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Children with acute malnutrition are at high risk of morality. Mass azithromycin distribution reduces all-cause mortality among children aged 1-59 months, and effects may be greater in underweight infants. Here, we evaluate the efficacy of azithromycin for reducing all-cause mortality in children aged 6-59 months with acute malnutrition (mid-upper arm circumference, MUAC, < 12.5 cm). Communities in Nouna District, Burkina Faso were 1:1 randomized to biannual mass distribution of single dose azithromycin or placebo to all children aged 1-59 months. Mortality was assessed during each census and treatment round. MUAC measurements were collected for all children. We evaluated the effect of azithromycin on mortality in subgroups of children aged 6-59 months defined by acute malnutrition (MUAC < 12.5 cm versus MUAC ≥ 12.5 cm). In children with MUAC < 12.5 cm, mortality rates were 51% lower among those living in azithromycin communities compared to placebo (incidence rate ratio 0.49, 95% confidence interval, CI, 0.25 to 0.99; incidence rate difference -18.1 deaths per 1,000 person-years, 95% CI -37.0 to -0.01), which was greater than the reduction in mortality among children with MUAC ≥ 12.5 cm (P-value for interaction on the relative scale = 0.09; P-value for interaction of the additive scale = 0.03). Children with acute malnutrition may benefit from single dose azithromycin above and beyond those without acute malnutrition. Trial registration: ClinicalTrials.gov NCT03676764; https://clinicaltrials.gov/study/NCT03676764.
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BACKGROUND: Schistosomiasis remains a public health problem, particularly in sub-Saharan Africa. The disease is intimately connected to poverty and environmental factors. Our research was readily embedded into a multi-country schistosomiasis oversampling study. The aim of the study presented here was to determine the prevalence of Schistosoma mansoni and to investigate the role of water body characteristics and water-related human activities in disease transmission. METHODS: In August and September 2022, a cross-sectional study was conducted in the western part of Côte d'Ivoire. Stool and urine samples were collected from 1602 and 1729 children aged 5-14 years, respectively, in 65 villages in the health districts of Biankouma, Ouaninou and Touba. Additionally, data were collected from direct observation of water-related activities at water bodies and interviews conducted with community leaders and health workers. The prevalence and risk factors for Schistosoma infection were assessed using generalised estimating equation models. RESULTS: The prevalence ofS. mansoni and S. haematobium were 27.4% (95% confidence interval [CI] 21.5-34.3%) and 0.1% (95% CI 0.03-0.5%), respectively. Low prevalence of soil-transmitted helminths was observed with 2.4%, 0.4% and 0.2% for hookworm, Trichuris trichiura and Ascaris lumbricoides, respectively. At the health district level, we found S. mansoni prevalence of 34.4% (95% CI 25.0-45.3%), 34.3% (95% CI 24.0-46.2%) and 16.3% (95% CI 9.5-26.6%) for Biankouma, Ouaninou and Touba, respectively. Female and male participants were at a similar risk of infection (29.0% vs. 26.0%, odds ratio [OR]: 1.18, 95% CI 0.92-1.50). Children aged 9-14 years showed a higher prevalence than their younger counterparts aged 5-8 years (34.5% vs. 22.7%, OR: 1.80, 95% CI 1.42-2.27). High infection prevalence was observed in villages where children were washing clothes and dishes at open surface water sites and pursued recreational activities (e.g. swimming and playing in the water). The temperature, total dissolved solids and pH of water samples showed no significant association with S. mansoni infection at the village unit. CONCLUSIONS: Human water-related activities such as washing clothes and playing in the water are risk factors for S. mansoni transmission. Hence, preventive chemotherapy should be combined with information, education and communication to avoid or reduce the frequency of water exposure in children as part of a comprehensive package of interventions towards elimination of schistosomiasis as a public health problem.
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Heces , Schistosoma mansoni , Esquistosomiasis mansoni , Agua , Humanos , Côte d'Ivoire/epidemiología , Niño , Estudios Transversales , Masculino , Femenino , Adolescente , Animales , Esquistosomiasis mansoni/epidemiología , Esquistosomiasis mansoni/transmisión , Esquistosomiasis mansoni/parasitología , Prevalencia , Preescolar , Factores de Riesgo , Heces/parasitología , Agua/parasitología , Schistosoma haematobiumRESUMEN
Although community randomized trials have found a reduction in all-cause child mortality in communities receiving mass azithromycin distribution compared with placebo, individually randomized trials have not found similar protective effects. If a direct effect of azithromycin for prevention of child mortality exists, it is likely due to reduction in infectious mortality. Here, we assessed cause-specific mortality in a large randomized controlled trial of azithromycin administered during well-infant visits in Burkina Faso for prevention of mortality. Among 32,877 enrolled infants, the most common causes of death by 6 months of age were malaria, acute respiratory infections, and diarrheal disease. We found no evidence of a difference in the distribution of cause of death by randomized treatment assignment (P = 0.42) or in any infectious-specific cause of death. The results of this analysis are consistent with no direct effect of azithromycin on infant mortality when administered during well-infant visits.
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The elimination of schistosomiasis as a public health problem by 2030 is one of the main goals put forth in the World Health Organization's roadmap for neglected tropical diseases. This study aimed to compare different sampling approaches to guide mapping and preventive chemotherapy. A cross-sectional parasitological survey was conducted from August to September 2022 in the health districts of Biankouma, Ouaninou, and Touba in the western part of Côte d'Ivoire. The prevalence and intensity of Schistosoma mansoni infection were assessed in children aged 5-14 years using three sampling approaches. The first approach involved a random selection of 50% of the villages in the health districts. The second approach involved a random selection of half of the villages selected in approach 1, thus constituting 25% of the villages in the health district. The third approach consisted of randomly selecting 15 villages from villages selected by approach 2 in each health district. The overall prevalence of S. mansoni was 23.5% (95% confidence interval (CI): 19.9-27.6%), 21.6% (95% CI: 17.1-26.8%), and 18.3% (95% CI: 11.9-27.1%) with the first, second, and third approach, respectively. The respective geometric mean S. mansoni infection intensity was 117.9 eggs per gram of stool (EPG) (95% CI: 109.3-127.3 EPG), 104.6 EPG (95% CI: 93.8-116.6 EPG), and 94.6 EPG (95% CI 79.5-112.7 EPG). We conclude that, although randomly sampling up to 50% of villages in a health district provides more precise population-based prevalence and intensity measures of S. mansoni, randomly selecting only 15 villages in a district characterized by low heterogeneity provides reasonable estimates and is less costly.
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Single-dose azithromycin is being considered by the WHO as an intervention for prevention of child mortality. However, concerns have emerged related to longer term unintended consequences of early life antibiotic use, particularly among infants. We conducted a long-term follow-up in a random sample of children who had been enrolled in a trial of neonatal azithromycin versus placebo for prevention of mortality to assess whether neonatal azithromycin exposure led to differences in child growth up to 4 years of age. We found no evidence of a difference in any anthropometric outcome among children who had received a single oral dose of azithromycin compared with placebo during the neonatal period. These results do not support long-term growth-promoting or deleterious effects of early life azithromycin exposure.
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Antibacterianos , Azitromicina , Humanos , Azitromicina/uso terapéutico , Azitromicina/administración & dosificación , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Antibacterianos/efectos adversos , Recién Nacido , Femenino , Lactante , Estudios de Seguimiento , Preescolar , Masculino , Desarrollo Infantil/efectos de los fármacos , Mortalidad del NiñoRESUMEN
The geographical range of schistosomiasis is affected by the ecology of schistosome parasites and their obligate host snails, including their response to temperature. Previous models predicted schistosomiasis' thermal optimum at 21.7 °C, which is not compatible with the temperature in sub-Saharan Africa (SSA) regions where schistosomiasis is hyperendemic. We performed an extensive literature search for empirical data on the effect of temperature on physiological and epidemiological parameters regulating the free-living stages of S. mansoni and S. haematobium and their obligate host snails, i.e., Biomphalaria spp. and Bulinus spp., respectively. We derived nonlinear thermal responses fitted on these data to parameterize a mechanistic, process-based model of schistosomiasis. We then re-cast the basic reproduction number and the prevalence of schistosome infection as functions of temperature. We found that the thermal optima for transmission of S. mansoni and S. haematobium range between 23.1-27.3 °C and 23.6-27.9 °C (95 % CI) respectively. We also found that the thermal optimum shifts toward higher temperatures as the human water contact rate increases with temperature. Our findings align with an extensive dataset of schistosomiasis prevalence in SSA. The refined nonlinear thermal-response model developed here suggests a more suitable current climate and a greater risk of increased transmission with future warming for more than half of the schistosomiasis suitable regions with mean annual temperature below the thermal optimum.
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The geographical range of schistosomiasis is affected by the ecology of schistosome parasites and their obligate host snails, including their response to temperature. Previous models predicted schistosomiasis' thermal optimum at 21.7°C, which is not compatible with the temperature in sub-Saharan Africa (SSA) regions where schistosomiasis is hyperendemic. We performed an extensive literature search for empirical data on the effect of temperature on physiological and epidemiological parameters regulating the free-living stages of S. mansoni and S. haematobium and their obligate host snails, i.e., Biomphalaria spp. and Bulinus spp., respectively. We derived nonlinear thermal responses fitted on these data to parameterize a mechanistic, process-based model of schistosomiasis. We then re-cast the basic reproduction number and the prevalence of schistosome infection as functions of temperature. We found that the thermal optima for transmission of S. mansoni and S. haematobium range between 23.1-27.3°C and 23.6-27.9°C (95% CI) respectively. We also found that the thermal optimum shifts toward higher temperatures as the human water contact rate increases with temperature. Our findings align with an extensive dataset of schistosomiasis prevalence in SSA. The refined nonlinear thermal-response model developed here suggests a more suitable current climate and a greater risk of increased transmission with future warming for more than half of the schistosomiasis suitable regions with mean annual temperature below the thermal optimum.
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Schistosoma haematobium , Schistosoma mansoni , Temperatura , Animales , Humanos , Schistosoma haematobium/fisiología , Schistosoma mansoni/fisiología , África del Sur del Sahara/epidemiología , Biomphalaria/parasitología , Esquistosomiasis/transmisión , Esquistosomiasis/epidemiología , Esquistosomiasis mansoni/transmisión , Esquistosomiasis mansoni/epidemiología , Bulinus/parasitología , Esquistosomiasis Urinaria/transmisión , Esquistosomiasis Urinaria/epidemiología , PrevalenciaRESUMEN
Importance: Repeated mass distribution of azithromycin has been shown to reduce childhood mortality by 14% in sub-Saharan Africa. However, the estimated effect varied by location, suggesting that the intervention may not be effective in different geographical areas, time periods, or conditions. Objective: To evaluate the efficacy of twice-yearly azithromycin to reduce mortality in children in the presence of seasonal malaria chemoprevention. Design, Setting, and Participants: This cluster randomized placebo-controlled trial evaluating the efficacy of single-dose azithromycin for prevention of all-cause childhood mortality included 341 communities in the Nouna district in rural northwestern Burkina Faso. Participants were children aged 1 to 59 months living in the study communities. Interventions: Communities were randomized in a 1:1 ratio to receive oral azithromycin or placebo distribution. Children aged 1 to 59 months were offered single-dose treatment twice yearly for 3 years (6 distributions) from August 2019 to February 2023. Main Outcomes and Measures: The primary outcome was all-cause childhood mortality, measured during a twice-yearly enumerative census. Results: A total of 34â¯399 children (mean [SD] age, 25.2 [18] months) in the azithromycin group and 33â¯847 children (mean [SD] age, 25.6 [18] months) in the placebo group were included. A mean (SD) of 90.1% (16.0%) of the censused children received the scheduled study drug in the azithromycin group and 89.8% (17.1%) received the scheduled study drug in the placebo group. In the azithromycin group, 498 deaths were recorded over 60â¯592 person-years (8.2 deaths/1000 person-years). In the placebo group, 588 deaths were recorded over 58â¯547 person-years (10.0 deaths/1000 person-years). The incidence rate ratio for mortality was 0.82 (95% CI, 0.67-1.02; P = .07) in the azithromycin group compared with the placebo group. The incidence rate ratio was 0.99 (95% CI, 0.72-1.36) in those aged 1 to 11 months, 0.92 (95% CI, 0.67-1.27) in those aged 12 to 23 months, and 0.73 (95% CI, 0.57-0.94) in those aged 24 to 59 months. Conclusions and Relevance: Mortality in children (aged 1-59 months) was lower with biannual mass azithromycin distribution in a setting in which seasonal malaria chemoprevention was also being distributed, but the difference was not statistically significant. The study may have been underpowered to detect a clinically relevant difference. Trial Registration: ClinicalTrials.gov Identifier: NCT03676764.
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Antibacterianos , Azitromicina , Mortalidad del Niño , Malaria , Humanos , Azitromicina/provisión & distribución , Azitromicina/uso terapéutico , Burkina Faso/epidemiología , Quimioprevención/métodos , Quimioprevención/estadística & datos numéricos , Mortalidad del Niño/tendencias , Malaria/epidemiología , Malaria/mortalidad , Malaria/prevención & control , Antibacterianos/provisión & distribución , Antibacterianos/uso terapéutico , Estaciones del Año , Lactante , PreescolarRESUMEN
BACKGROUND: Mass distribution of azithromycin to children 1 to 59 months of age has been shown to reduce childhood all-cause mortality in some sub-Saharan African regions, with the largest reduction seen among infants younger than 12 months of age. Whether the administration of azithromycin at routine health care visits for infants would be effective in preventing death is unclear. METHODS: We conducted a randomized, placebo-controlled trial of a single dose of azithromycin (20 mg per kilogram of body weight) as compared with placebo, administered during infancy (5 to 12 weeks of age). The primary end point was death before 6 months of age. Infants were recruited at routine vaccination or other well-child visits in clinics and through community outreach in three regions of Burkina Faso. Vital status was assessed at 6 months of age. RESULTS: Of the 32,877 infants enrolled from September 2019 through October 2022, a total of 16,416 infants were randomly assigned to azithromycin and 16,461 to placebo. Eighty-two infants in the azithromycin group and 75 infants in the placebo group died before 6 months of age (hazard ratio, 1.09; 95% confidence interval [CI], 0.80 to 1.49; P = 0.58); the absolute difference in mortality was 0.04 percentage points (95% CI, -0.10 to 0.21). There was no evidence of an effect of azithromycin on mortality in any of the prespecified subgroups, including subgroups defined according to age, sex, and baseline weight, and no evidence of a difference between the two trial groups in the incidence of adverse events. CONCLUSIONS: In this trial conducted in Burkina Faso, we found that administration of azithromycin to infants through the existing health care system did not prevent death. (Funded by the Bill and Melinda Gates Foundation; CHAT ClinicalTrials.gov number, NCT03676764.).
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Antibacterianos , Azitromicina , Mortalidad Infantil , Niño , Humanos , Lactante , Antibacterianos/administración & dosificación , Antibacterianos/uso terapéutico , Azitromicina/administración & dosificación , Azitromicina/uso terapéutico , Mortalidad Infantil/tendencias , Administración Masiva de Medicamentos/métodos , Administración Masiva de Medicamentos/mortalidad , Administración Masiva de Medicamentos/estadística & datos numéricos , Burkina Faso/epidemiologíaRESUMEN
BACKGROUND: Antibiotic use during early infancy has been linked to childhood obesity in high-income countries. We evaluated whether a single oral dose of azithromycin administered during infant-well visits led to changes in infant growth outcomes at 6 months of age in a setting with a high prevalence of undernutrition in rural Burkina Faso. METHODS AND FINDINGS: Infants were enrolled from September 25, 2019, until October 22, 2022, in a randomized controlled trial designed to evaluate the efficacy of a single oral dose of azithromycin (20 mg/kg) compared to placebo when administered during well-child visits for prevention of infant mortality. The trial found no evidence of a difference in the primary endpoint. This paper presents prespecified secondary anthropometric endpoints including weight gain (g/day), height change (mm/day), weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and mid-upper arm circumference (MUAC). Infants were eligible for the trial if they were between 5 and 12 weeks of age, able to orally feed, and their families were planning to remain in the study area for the duration of the study. Anthropometric measurements were collected at enrollment (5 to 12 weeks of age) and 6 months of age. Among 32,877 infants enrolled in the trial, 27,298 (83%) were followed and had valid anthropometric measurements at 6 months of age. We found no evidence of a difference in weight gain (mean difference 0.03 g/day, 95% confidence interval (CI) -0.12 to 0.18), height change (mean difference 0.004 mm/day, 95% CI -0.05 to 0.06), WAZ (mean difference -0.004 SD, 95% CI -0.03 to 0.02), WLZ (mean difference 0.001 SD, 95% CI -0.03 to 0.03), LAZ (mean difference -0.005 SD, 95% CI -0.03 to 0.02), or MUAC (mean difference 0.01 cm, 95% CI -0.01 to 0.04). The primary limitation of the trial was that measurements were only collected at enrollment and 6 months of age, precluding assessment of shorter-term or long-term changes in growth. CONCLUSIONS: Single-dose azithromycin does not appear to affect weight and height outcomes when administered during early infancy. TRIAL REGISTRATION: ClinicalTrials.gov NCT03676764.
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Azitromicina , Obesidad Infantil , Niño , Lactante , Humanos , Azitromicina/efectos adversos , Burkina Faso/epidemiología , Aumento de Peso , Antibacterianos/efectos adversosRESUMEN
Mass antibiotic distribution to preschool children resulted in alterations of the gut microbiome months after distribution. This individually randomized, placebo-controlled trial evaluated changes in the gut microbiome and resistome in children aged 8 days to 59 months after one dose of oral azithromycin in Burkina Faso. A total of 450 children were randomized in a 1:1 ratio to either placebo or azithromycin. Rectal samples were collected at baseline, 2 weeks, and 6 months after randomization and subjected to DNA deep sequencing. Gut microbiome diversity and normalized antimicrobial resistance determinants for different antibiotic classes were evaluated. Azithromycin decreased gut bacterial diversity (Shannon P < 0.0001; inverse Simpson P < 0.001) 2 weeks after treatment relative to placebo. Concurrently, the normalized abundance of macrolide resistance genetic determinants was 243-fold higher (95% CI: 76-fold to 776-fold, P < 0.0001). These alterations did not persist at 6 months, suggesting that disruptions were transient. Furthermore, we were unable to detect resistance changes in other antibiotic classes, indicating that co-resistance with a single course of azithromycin when treated at the individual level was unlikely.
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Azitromicina , Microbioma Gastrointestinal , Humanos , Preescolar , Azitromicina/uso terapéutico , Antibacterianos/uso terapéutico , Macrólidos , Farmacorresistencia Bacteriana/genéticaRESUMEN
Clinic-based recruitment for preventative interventions for child health may select for healthier populations compared with community-based outreach. Nutritional status during infancy as measured by anthropometry is predictive of mortality, growth faltering later in life, and poor cognitive development outcomes. We evaluated baseline differences in infant nutritional status among children recruited directly in their community versus clinic recruitment among infants participating in a trial of azithromycin compared with placebo for prevention of mortality in three districts of Burkina Faso. Infants between 5 and 12 weeks of age were recruited in their community of residence via vaccine outreach teams or in primary health-care clinics during vaccine clinics. Weight, height, and mid upper arm circumference were measured. We used linear and logistic regression models to compare anthropometric outcomes among community and clinic recruited infants, adjusting for age at enrollment, gender, and season. Among 32,877 infants enrolled in the trial, 21,273 (64.7%) were recruited via community outreach. Mean weight-for-age z-score (WAZ) was -0.60 ± 1.2 (SD), weight-for-length z-score (WLZ) was -0.16 ± 1.5, and length-for-age z-score was-0.53 ± 1.3. Infants enrolled in the community had lower WAZ (mean difference, -0.12; 95% CI, -0.20 to -0.04) and WLZ (mean difference, -0.21; 95% CI, -0.32 to -0.09). Community-recruited infants were more often underweight (WAZ < -2; odds ratio [OR], 1.25; 95% CI, 1.09-1.43) and wasted (WLZ < -2; OR, 1.54; 95% CI, 1.31-1.79). There was no evidence of a difference in height-based measures. Community and clinic recruitment likely reach different populations of children.
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Azitromicina , Vacunas , Niño , Humanos , Lactante , Antropometría , Azitromicina/uso terapéutico , Burkina Faso/epidemiología , Mortalidad del NiñoRESUMEN
BACKGROUND: Schistosomiasis and hookworm infection remain public health problems in large parts of sub-Saharan Africa. The epidemiology of schistosomiasis and hookworm was studied in seasonal transmission settings in the northern part of Côte d'Ivoire. METHODOLOGY: In August 2018, a cross-sectional study was conducted. Urine and stool samples were collected from 742 individuals aged 6-96 years in 16 localities from four departments in northern Côte d'Ivoire. Urine samples were examined by a filtration method for quantification of Schistosoma haematobium eggs. Stool samples were subjected to duplicate Kato-Katz thick smears and eggs of Schistosoma mansoni and soil-transmitted helminths (STHs) were counted. Additionally, a questionnaire was administered to determine demographic characteristics and to identify risk factors of schistosomiasis and STHs. Malacologic surveys were carried out at water points that are contacted by humans and animals. PRINCIPAL FINDINGS: The prevalence of schistosomiasis was very low. Only two cases of S. mansoni were found (0.3%, 95% confidence interval [CI]: 0.1-1.0%). The distribution of S. haematobium was focal, with cases found only in two departments; Ferkessédougou (5.4%, 95% CI: 2.5-9.9%) and Ouangolodougou (2.7%, 95% CI: 0.9-6.3%). Hookworm was the only STH species observed with a prevalence of 1.5% (95% CI: 0.8-2.8%). A higher risk of S. haematobium infection was observed in males compared to females, but the difference was not statistically significant (2.3% versus 1.3%, odds ratio [OR]: 1.5, 95% CI: 0.8-2.7). Participants aged 16-20 years showed the highest prevalence of S. haematobium. A total of 111 human- and animal-water contact points were identified at 47 water sources. Three potential intermediate host snails of schistosomes were collected; namely, Bulinus forskalii (n = 761), Bulinus truncatus (n = 205), and Biomphalaria pfeifferi (n = 1). Yet, only one specimen of Bu. truncatus was found to be shedding schistosome cercariae. CONCLUSIONS/SIGNIFICANCE: This study confirms very low transmission of schistosomiasis and hookworm in northern Côte d'Ivoire. The establishment and rigorous implementation of integrated surveillance-response systems could lead to the elimination of schistosomiasis and hookworm in this part of Côte d'Ivoire.
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Infecciones por Uncinaria , Esquistosomiasis mansoni , Esquistosomiasis , Masculino , Femenino , Animales , Humanos , Estudios Transversales , Côte d'Ivoire/epidemiología , Prevalencia , Estaciones del Año , Esquistosomiasis/epidemiología , Schistosoma haematobium/fisiología , Bulinus , Infecciones por Uncinaria/epidemiología , Suelo/parasitología , Factores de Riesgo , Agua , Esquistosomiasis mansoni/epidemiología , Esquistosomiasis mansoni/parasitología , Heces/parasitologíaRESUMEN
Observational studies have linked early-life antibiotic exposure to increased risk of obesity in children in high income settings. We evaluated whether neonatal antibiotic exposure led to changes in infant growth at 6 months of age in Burkina Faso. Neonates aged 8 to 27 days of age who weighed at least 2,500 g at the time of enrollment were randomized in a 1:1 fashion to a single oral 20-mg/kg dose of azithromycin or equivalent volume of placebo from April 2019 through December 2020. Weight, length, and mid-upper-arm circumference (MUAC) were measured at baseline and 6 months of age. Growth outcomes, including weight gain in grams per day, length change in millimeters per day, and changes in weight-for-age Z-score (WAZ), weight-for-length Z-score (WLZ), length-for-age Z-score (LAZ), and MUAC were compared among neonates randomized to azithromycin compared with placebo. Among 21,832 neonates enrolled in the trial, median age at enrollment was 11 days, and 50% were female. We found no evidence of a difference in weight gain (mean difference -0.009 g/day, 95% confidence interval [CI]: -0.16 to 0.14, P = 0.90), length change (mean difference 0.003 mm/day, 95% CI: -0.002 to 0.007, P = 0.23), or WAZ (mean difference -0.005 SD, 95% CI: -0.03 to 0.02, P = 0.72), WLZ (mean difference -0.01 SD, 95% CI: -0.05 to 0.02, P = 0.39), LAZ (mean difference 0.01, 95% CI: -0.02 to 0.04, P = 0.47), or MUAC (mean difference 0.01 cm, 95% CI: -0.02 to 0.04, P = 0.49). These results do not suggest that azithromycin has growth-promoting properties in infants when administered during the neonatal period. Trial registration: ClinicalTrials.gov NCT03682653.
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Azitromicina , Obesidad Infantil , Recién Nacido , Niño , Lactante , Humanos , Femenino , Masculino , Aumento de Peso , Antibacterianos , Burkina FasoRESUMEN
BACKGROUND: WHO has underlined the need for a child-friendly treatment for schistosomiasis, a prevalent parasitic disease in low-income and middle-income countries. After successful phase 1 and 2 trials, we aimed to evaluate the efficacy, safety, palatability, and pharmacokinetics of arpraziquantel (L-praziquantel) orodispersible tablets for preschool-aged children. METHODS: This open-label, partly randomised, phase 3 study was conducted at two hospitals in Côte d'Ivoire and Kenya. Children with a minimum bodyweight of 5 kg in those aged 3 months to 2 years and 8 kg in those aged 2-6 years were eligible. In cohort 1, participants aged 4-6 years infected with Schistosoma mansoni were randomly assigned (2:1) to receive a single dose of oral arpraziquantel 50 mg/kg (cohort 1a) or oral praziquantel 40 mg/kg (cohort 1b) using a computer-generated randomisation list. Cohorts 2 (aged 2-3 years) and 3 (aged 3 months to 2 years) infected with S mansoni, and the first 30 participants in cohort 4a (aged 3 months to 6 years) infected with Schistosoma haematobium, received a single dose of oral arpraziquantel 50 mg/kg. After follow-up assessments, arpraziquantel was increased to 60 mg/kg (cohort 4b). Laboratory personnel were masked to the treatment group, screening, and baseline values. S mansoni was detected using a point-of-care circulating cathodic antigen urine cassette test and confirmed using the Kato-Katz method. The primary efficacy endpoint was clinical cure rate at 17-21 days after treatment in cohorts 1a and 1b, measured in the modified intention-to-treat population and calculated using the Clopper-Pearson method. This study is registered with ClinicalTrials.gov, NCT03845140. FINDINGS: Between Sept 2, 2019, and Aug 7, 2021, 2663 participants were prescreened and 326 were diagnosed with S mansoni or S haematobium. 288 were enrolled (n=100 in cohort 1a, n=50 in cohort 1b, n=30 in cohort 2, n=18 in cohort 3, n=30 in cohort 4a, and n=60 in cohort 4b), but eight participants received antimalarial drugs and were excluded from the efficacy analyses. The median age was 5·1 years (IQR 4·1-6·0) and 132 (47%) of 280 participants were female and 148 (53%) were male. Cure rates with arpraziquantel were similar to those with praziquantel (87·8% [95% CI 79·6-93·5] in cohort 1a vs 81·3% [67·4-91·1] in cohort 1b). No safety concerns were identified during the study. The most common drug-related treatment-emergent adverse events were abdominal pain (41 [14%] of 288 participants), diarrhoea (27 [9%]), vomiting (16 [6%]), and somnolence (21 [7%]). INTERPRETATION: Arpraziquantel, a first-line orodispersible tablet, showed high efficacy and favourable safety in preschool-aged children with schistosomiasis. FUNDING: The Global Health Innovative Technology Fund, the European and Developing Countries Clinical Trials Partnership, and the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).
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Antihelmínticos , Esquistosomiasis mansoni , Esquistosomiasis , Animales , Preescolar , Masculino , Femenino , Humanos , Praziquantel/efectos adversos , Côte d'Ivoire , Kenia , Esquistosomiasis mansoni/tratamiento farmacológico , Esquistosomiasis mansoni/diagnóstico , Esquistosomiasis mansoni/prevención & control , Antihelmínticos/efectos adversos , Schistosoma mansoni , Esquistosomiasis/tratamiento farmacológicoRESUMEN
The relationship between malaria infection and malnutrition is complex. Using data from a randomized controlled trial of 450 children 0-5 years of age in Burkina Faso, we examined the effect of malaria infection on short-term changes in anthropometric measures, the effect of malnutrition on malaria infection, and whether age modified the effect of baseline anthropometric measures on malaria infection. Malaria infection, assessed by blood smear microscopy and weight, height, mid-upper arm circumference, height-for-age z-score, weight-for-age z-score, and weight-for-height z-score were measured at three time points: baseline, 2 weeks, and 6 months. We used generalized estimating equations adjusted for sex, age, breastfeeding, maternal education, and study treatment (azithromycin versus placebo) for all analyses. Interaction terms were used to assess effect modification by age. Among the 366 children with no malaria infection at baseline, 43 (11.6%) had malaria infection within 6 months. There were no important differences in anthropometric measures at 2 weeks and 6 months between those with and without malaria infection at baseline. There were no significant differences in prevalence of malaria infection by baseline anthropometric measures. Age (0-30 months versus 30-60 months) modified the effect of baseline weight and height on malaria infection. Among those aged 0-30 months, for each kilogram increase in weight, malaria infection increased by 27% (95% CI: 6-53%), and for each centimeter increase in height, it increased by 9% (95% CI: 1-17%), but there were no differences for those aged 30-60 months.
Asunto(s)
Malaria , Desnutrición , Femenino , Niño , Humanos , Lactante , Preescolar , Recién Nacido , Burkina Faso/epidemiología , Estudios Longitudinales , Desnutrición/epidemiología , Peso CorporalRESUMEN
RésuméMalgré la dépénalisation de l'avortement et la gratuité des soins après avortement (SAA), les femmes Burkinabè vivent des relations difficiles avec les soignants. Cette étude vise à déterminer le profil des femmes recevant des SAA, leur perception de la qualité des SAA et ses déterminants dans des structures sanitaires publiques et confessionnelles du pays. Une enquête quantitative a été menée auprès de 2174 femmes vues pour des SAA et recrutées de façon exhaustive de 2018 à 2020. Un questionnaire structuré a été administré à la sortie des soins. Une analyse uni-, bi- et multivariée a été faite. La majorité des clientes de SAA vivait en milieu rural (55%), avait 25 ans et plus (60%), vivait en couple (87%) et était sans-emploi (59%). La grossesse était non désirée chez 17% des femmes et 4% d'entre elles souhaitaient avorter. La satisfaction globale de la qualité des SAA était de 84%. Dans l'analyse multivariée, ses déterminants étaient la résidence en milieu rural (OR = 1.80 [1.38; 2.34]), un niveau scolaire primaire (OR = 1.48 [1.06; 2.07]) ou secondaire (OR = 1.95 [1.38; 2.74]), et avoir eu au moins un enfant (OR = 1.43 [1.02; 2.00]). Les facteurs associés à une faible satisfaction des SAA étaient une grossesse non désirée (OR = 0.64 [0.46; 0.89]) ou avoir souhaité avorter (OR = 0.09 [0.05; 0.16]). Le niveau de satisfaction globale est acceptable mais faible chez les clientes ayant souhaité avorter. Il est fondamental d'organiser un programme de formation des professionnels des SAA sur la communication, la relation interpersonnelle et l'empathie pendant les soins de santé.
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Resinas Compuestas , Humanos , Burkina FasoRESUMEN
Background and Aims: hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) represent the major transfusion-transmissible pathogens worldwide. The risk of transmission is relatively high in African countries, mainly due to unreliable screening methods of blood donations. In Burkina Faso, predonation screening using rapid diagnostic tests (RDTs) is widespread, raising the major question of the transfusion safety in the country. The objective of this study was to assess the risk of transmission of HBV, HCV, and HIV through blood transfusion in the context of the use of RDTs for screening of the blood donations. Methods: In this cross-sectional study, a total of 417 serum samples obtained from blood donors tested negative for HBsAg, anti-HCV, and anti-HIV using RDTs were retested for the same markers using chemiluminescent immunologic assays. Total antibodies to HBV core (anti-HBc) were tested on randomly selected samples. HBV-DNA and HCV-RNA viral loads (VLs) were quantified on HBsAg and anti-HCV positive samples, respectively. To assess possible occult hepatitis B infection (OBI), HBV-DNA-VL was quantified on 313 randomly selected HBsAg-negative samples. Results: HBsAg and anti-HCV were found respectively in 6 (6/417; 1.4%) and 11 (11/417; 2.6%) samples. No samples were reactive for anti-HIV. Total anti-HBc were detected in 217 out of the 319 randomly selected samples (217/319; 68.02%). HBV-DNA was detected in four (4/313; 1.27%) samples, including two (2/6; 33.33%) of the six HBsAg positive samples and two (2/313; 0.6%) of the HBsAg-negative samples, suggesting two cases of occult HBV infection. All anti-HCV antibody-positive samples were HCV-RNA negative. Conclusion: This study shows that RDTs are not sufficiently sensitive for the screening of blood donations. Our results highlight the urgent need to think about the extension of sensitive immunological tests in all blood transfusion centers and also the implementation of nucleic acid amplification techniques.
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Food safety risks are becoming a public health problem with important socioeconomic consequences for human wellbeing, especially for pregnant women and infants. In this article, we describe findings from microbiological, toxicological, and nutritional quality assessments of foods from 5 localities in Burkina Faso, with the aim to provide baseline data on the quality of food and the risks to mothers and children. Samples for assessment included food sold in markets, stores, and restaurants (eg, cereals, oilseeds, vegetables, edible oils, powdered milk, dried fish, packaged water, ready-to-eat meals). The research team selected the samples using the random route method and analyzed them at the National Public Health Laboratory in Ouagadougou between January and December 2020. A total of 443 food samples were collected, of which 101 were analyzed for microbial contamination, 360 were analyzed for the presence of toxins, and 59 were analyzed for their nutritional value. The microbiological quality of 11.88% of the food samples was unsatisfactory, and 41.50% were contaminated with aflatoxins. At least 1 pesticide residue and cyfluthrin were detected in 58.10% of samples. The most detected contaminant (cyfluthrin) was found in 79.10% of the analyzed samples. A peroxide index higher than the normal value (10 mEq/kg) was found in 3.38% of the oil samples and 76.27% of the oil samples had a vitamin A content lower than the recommended limit of 11 mg/kg. This study is the first in Burkina Faso that provides baseline data on the quality of food and potential health risks to mothers and children in Burkina Faso. Considering the level of contaminants reported in this article, it is imperative to enhance routine monitoring of foods in the country.
Asunto(s)
Alimentos , Restaurantes , Animales , Burkina Faso , Niño , Femenino , Humanos , Lactante , EmbarazoRESUMEN
BACKGROUND: In many parts of sub-Saharan Africa, access to abortion is legally restricted, which partly contributes to high incidence of unsafe abortion. This may result in unsafe abortion-related complications that demand long hospital stays, treatment and attendance by skilled health providers. There is however, limited knowledge on the capacity of public health facilities to deliver post-abortion care (PAC), and the spread of PAC services in these settings. We describe and discuss the preparedness and capacity of public health facilities to deliver complete and quality PAC services in Burkina Faso, Kenya and Nigeria. METHODS: A cross-sectional survey of primary, secondary and tertiary-level public health facilities was conducted between November 2018 and February 2019 in the three countries. Data on signal functions (including information on essential equipment and supplies, staffing and training among others) for measuring the ability of health facilities to provide post-abortion services were collected and analyzed. RESULTS: Across the three countries, fewer primary health facilities (ranging from 6.3-12.1% in Kenya and Burkina Faso) had the capacity to deliver on all components of basic PAC services. Approximately one-third (26-43%) of referral facilities across Burkina Faso, Kenya and Nigeria could provide comprehensive PAC services. Lack of trained staff, absence of necessary equipment and lack of PAC commodities and supplies were a main reason for inability to deliver specific PAC services (such as surgical procedures for abortion complications, blood transfusion and post-PAC contraceptive counselling). Further, the lack of capacity to refer acute PAC cases to higher-level facilities was identified as a key weakness in provision of post-abortion care services. CONCLUSIONS: Our findings reveal considerable gaps and weaknesses in the delivery of basic and comprehensive PAC within the three countries, linked to both the legal and policy contexts for abortion as well as broad health system challenges in the countries. There is a need for increased investments by governments to strengthen the capacity of primary, secondary and tertiary public health facilities to deliver quality PAC services, in order to increase access to PAC and avert preventable maternal mortalities.