Facilitators and Barriers to National COVID 19 Guideline Adherence among Healthcare Providers in Ethiopia.

Background: Evidence-base practice needs to be supported by guidelines and decision-making protocols. This study aimed to look into the barriers and facilitators of adherence to national protocols in Ethiopia. Methods: Exploratory qualitative method was implemented to explore adherence to protocol. The national COVID-19 case management guideline was used as this study's prototype reference. A total of five FGDS were conducted among 26 healthcare providers. A total of 14 physicians and 12 nurses participated in the FGDs. Semi-structured focus group discussions guides were used to facilitate the discussion among healthcare workers involved in COVID-19 case management. The FGDs were audio recorded, transcribed and analyzed thematically. Results: Three broad themes have emerged from the content analysis. These include individual factors, environmental factors and system factors. System factors barriers to utilization include unclear guidelines, discordant guidelines and a lack of live national guidelines, while the main facilitator was supportive management. The environmental factors that were barriers to adherence included limited infrastructure and shortages of drugs suggested in the protocols. Conclusion: Outdated and discordant guidelines and a shortage of suggested managements were barriers. Future similar works should consider the identified barriers and need regular updates to facilitate effective implementation.

Prognostic factors and outcomes of COVID-19 cases in Ethiopia: multi-center cohort study protocol.

BACKGROUND: The coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2) and became pandemic after emerging in Wuhan, China, in December 2019. Several studies have been conducted to understand the key features of COVID-19 and its public health impact. However, the prognostic factors of COVID-19 are not well studied in the African setting. In this study, we aim to determine the epidemiological and clinical features of COVID-19 cases, immunological and virological courses, interaction with nutritional status, and response to treatment for COVID-19 patients in Ethiopia. METHODS: A multi-center cohort study design will be performed. Patients with confirmed COVID-19 infection admitted to selected treatment centers will be enrolled irrespective of their symptoms and followed-up for 12 months. Baseline epidemiological, clinical, laboratory and imaging data will be collected from treatment records, interviews, physical measurements, and biological samples. Follow-up data collection involves treatment and prognostic outcomes to be measured using different biomarkers and clinical parameters. Data collection will be done electronically using the Open Data Kit (ODK) software package and then exported to STATA/SPSS for analysis. Both descriptive and multivariable analyses will be performed to assess the independent determinants of the treatment outcome and prognosis to generate relevant information for informed prevention and case management. The primary outcomes of this study are death/survival and viral shedding. Secondary outcomes include epidemiological characteristics, clinical features, genetic frequency shifts (genotypic variations), and nutritional status. DISCUSSION: This is the first large prospective cohort study of patients in hospitals with COVID-19 in Ethiopia. The results will enable us to better understand the epidemiology of SARS-CoV-2 in Africa. This study will also provide useful information for effective public health measures and future pandemic preparedness and in response to outbreaks. It will also support policymakers in managing the epidemic based on scientific evidence. TRIAL REGISTRATION: The Protocol prospectively registered in ClinicalTrials.gov (NCT04584424) on 30 October, 2020.

Clinical Characteristics of COVID-19 Related Deaths in Ethiopia.

BACKGROUND: Since the occurrence of COVID-19 in the world, it has claimed nearly 1.39 million human lives in the world and more than 1500 lives in Ethiopia. The number of deaths is increasing with variable distribution in the world. Despite its increasing fatality, the clinical characteristics of the deceased patients are not yet fully known. Analyzing the clinical characteristics of deceased patients will help to improve the outcome of infected patients. Hence, this study aimed to determine the clinical characteristics of patients who died due to COVID-19 in Ethiopia. METHODS: Hospital based multi-center cross-sectional study was conducted using chart review of deceased patients. Since the number of COVID-19 related deaths was limited, all consecutive COVID-19 related hospital deaths were analyzed. The data was entered into and analyzed using SPSS version 25.0. Descriptive statistics was used to explain the data collected from the survey. RESULT: A total of 92 deceased patient charts were analyzed. Of these patients, 65(71%) were males. Age ranged from 17 to 92 years (mean age being 59 years). On arrival vital signs, 60.5% of them had hypoxia, 49% had tachycardia and only 32% of patients had fever. Three fourth of the patients 64/85 had at least one comorbidity. Diabetes mellitus (DM) was the commonest comorbidity accounting for 445.9%, followed by hypertension, 23/85(27%), and HIV/ AIDS, 15/85 (17.5%). CONCLUSION: The results of this study showed that COVID-19 deceased patients presented with respiratory failure and hypoxia. However, less than a third of these patients had fever. In addition, the presence of comorbid illnesses and non-COVID-19 diseases like AIDS defining illness in significant amount needs further study to identify their level of contribution to the increasing burden of COVID-19 deaths in Ethiopia.

Clinical and Socio-demographic Profile of the First 33 COVID-19 Cases Treated at Dedicated Treatment Center in Ethiopia.

BACKGROUND: Severe respiratory tract infection caused by family of Corona viruses has become world pandemic. The purpose of this study was to describe the first few COVID 19 cases in Ethiopia. METHOD: Descriptive study was conducted on the first 33 consecutive RT-PCR confirmed COVID 19 cases diagnosed and managed at Ekka-Kotebe COVID Treatment Center in Addis Ababa, Ethiopia. RESULT: The median age of the cases was 36 years. Cough, headache and fever were the most frequent symptoms. Diarrhea, sore throats, loss of taste and/or smell sensation were among the rare symptoms. Most (84.8%) had mild to moderate disease, and 15.2%(n=5) were critical at the time of admission. Among the five ICU admissions, four patients required invasive mechanical ventilation. Thirty cases were discharged after two pairs of nasopharyngeal and oropharyngeal samples turned negative for SARS CoV2. Three cases from the ICU died while on mechanical ventilator. The age of the two deaths was 65 years, and one was 60 years. With the exception of three, all cases were either imported from abroad or had contact with confirmed cases. CONCLUSION: Most of our patients were in the younger age group with male predominance and few with comorbidities. Cough was the commonest symptom followed by headache and fever. As it was in the early stage of the pandemic, observation of more cases in the future will reveal further clinical and demographic profiles of COVID-19 cases in Ethiopia.

Clinical and socio-demographic profile of the first 33 COVID-19 cases treated at dedicated treatment center in Ethiopia

BACKGROUND:Severe respiratory tract infection caused by family of Corona viruses has become world pandemic. The purpose of this study was to describe the first few COVID 19 cases in Ethiopia. METHOD: Descriptive study was conducted on the first 33 consecutive RT-PCR confirmed COVID 19 cases diagnosed and managed at Ekka-Kotebe COVID Treatment Center in Addis Ababa, Ethiopia. RESULT: The median age of the cases was 36 years. Cough, headache and fever were the most frequent symptoms. Diarrhea, sore throats, loss of taste and/or smell sensation were among the rare symptoms. Most (84.8%) had mild to moderate disease, and 15.2%(n=5) were critical at the time of admission. Among the five ICU admissions, four patients required invasive mechanical ventilation. Thirty cases were discharged after two pairs of nasopharyngeal and oropharyngeal samples turned negative for SARS CoV2. Three cases from the ICU died while on mechanical ventilator. The age of the two deaths was 65 years, and one was 60 years. With the exception of three, all cases were either imported from abroad or had contact with confirmed cases. CONCLUSION: Most of our patients were in the younger age group with male predominance and few with comorbidities. Cough was the commonest symptom followed by headache and fever. As it was in the early stage of the pandemic, observation of more cases in the future will reveal further clinical and demographic profiles of COVID-19 cases in Ethiopia

Safety and efficacy of liposomal amphotericin B for treatment of complicated visceral leishmaniasis in patients without HIV, North-West Ethiopia.

BACKGROUND: Visceral leishmaniasis (VL) is a protozoan disease that is invariably fatal if left untreated. The disease is found in 70 countries with incidence of 0.2 - 0.4 million cases. The mainstay of treatment in resource limited countries like Ethiopia is antimonials, while use of liposomal amphotericin B is reserved for treatment of complicated VL cases. The aim of this study was to assess the safety and efficacy of liposomal amphotericin B in HIV negative VL patients diagnosed with complications. METHODS: A retrospective chart review was conducted involving records of patients admitted between January 2009 and December 2014. Baseline sociodemographic, clinical, and treatment outcome data were collected. The doses of liposomal amphotericin B and adverse events related to treatment were retrieved. Categorical and continuous variables respectively were analyzed by Chi-square and Mann-Whitney U tests. A p-value of less than 0.05 was considered statistically significant. RESULTS: A total of 147 patients with severe VL were treated with liposomal amphotericin B in total dose ranges of 20 mg/kg to 35 mg/kg. In the overall treatment outcome analysis, initial cure (30 days after start of treatment) was observed in 128 (87.1 %), treatment failures in 10 (6.8 %), interruptions in 2(1.4 %) and deaths in 7 (4.8 %) patients. Initial cure rate at high dose (24-35 mg/kg total dose) was 96.7 % (59/61) versus 80.2 % (69/86) at lower doses (<24 mg/kg); which was significantly higher (P < 0.01), OR = 4.56: 95 %, Confidence Interval (CI) = 1.17 - 20.78). Ten cases (11.8 %) of treatment failure occurred in the low dose treatment group. The most common adverse events (AEs) were hypokalemia in 39 cases (26.5 %) and infusion related reactions in 16 (10.9 %). The frequency of hypokalemia and infusion related reactions were not significantly different between the low and high dose liposomal amphotericin B. CONCLUSION: In HIV negative complicated VL patients, high dose of liposomal amphotericin B was found to have high cure rate at the end of treatment. The appropriate dose for better efficacy needs to be determined. Monitoring serum potassium level during treatment with liposomal amphotericin B should be an essential component of the clinical management of VL.

The additional yield of GeneXpert MTB/RIF test in the diagnosis of pulmonary tuberculosis among household contacts of smear positive TB cases.

OBJECTIVE: The objective of this study was to compare the diagnostic yield of GeneXpert MTB/RIF with Ziehl-Neelson (ZN) sputum smear microscopy among index TB cases and their household contacts. METHODS: A cross sectional study was conducted among sputum smear positive index TB cases and their household contacts in Northern Ethiopia. RESULTS: Of 353 contacts screened, 41 (11%) were found to have presumptive TB. GeneXpert test done among 39 presumptive TB cases diagnosed 14 (35.9%) cases of TB (one being rifampicin resistant), whereas the number of TB cases diagnosed by microscopy was only 5 (12.8%): a 64.3% increased positivity rate by GeneXpert versus ZN microscopy. The number needed to screen and number needed to test to diagnose a single case of TB was significantly lower with the use of GeneXpert than ZN microscopy. Of 119 index TB cases, GeneXpert test revealed that 106 (89.1%) and 5 (4.2%) were positive for rifampicin sensitive and rifampicin resistant TB, respectively. CONCLUSION: GeneXpert test led to increased TB case detection among household contacts in addition to its advantage in the diagnosis of Rifampicin resistance among contacts and index TB cases. There should be a consideration in using GeneXpert MTB/RIF as a point of care TB testing tool among high risk groups.

Childhood cancer in Gondar University Hospital, Northwest Ethiopia.

BACKGROUND: Childhood cancer becomes a public health problem in developing countries which aggravates the burden of childhood mortality by infectious diseases and malnutrition. In poor countries, the death rate for most pediatric cancers is almost 100%. This study attempts to determine the magnitude, patterns and trends of pediatric malignancies in the study area which is important in re-evaluating existing services and in improving facilities and patient care. METHODS: A retrospective study of 3 year period were carried out among all children aged below 15 years old admitted into the pediatric wards of Gondar University Hospital, Northwest Ethiopia. The charts of all children aged below 15 years old admitted in the pediatric wards due to cancer were reviewed by using the data collection format. Data were entered and analyzed using SPSS version 20 statistical package. RESULT: A total of 71 cancer cases were diagnosed and admitted to the pediatrics ward during the study period. More than two-third of the study subjects 50 (70.4%) were males. The mean age of study subjects was 7 ± 4 year where majority 26 (36.6%) of the study subjects were ≥10 years. Of all, 43 (60.6%) were hematological malignancy followed by Wilms tumor 13 (18.3%), Neuroblastoma 5 (7%), Rhabdomyosarcoma 3 (4.2%), Brain tumor 3 (4.2%), Hepatoblastoma 2 (2.8%). More than two-third of cases were found to be concomitantly malnourished being stunted, wasted and under weight. Nearly half of patients had not received chemotherapy and majority of those started chemotherapy did not complete all the treatment cycles. Shortage and absence of safe and affordable chemotherapy drugs were the major reasons for therapy interruption. CONCLUSION: The study shows increasing childhood cancer cases over the years. Hematological malignancy takes the leading prevalence followed by Wilms tumor and Neuroblastoma. The majority of cases were also discharged without any clinical change that had the only death option. Therefore, the government and the hospital should give emphasis to establish cancer therapy centers and insure accessibility and affordability of chemotherapy drugs.

Effect of deworming on Th2 immune response during HIV-helminths co-infection.

BACKGROUND: Helminths infections have been suggested to worsen the outcome of HIV infection by polarizing the immune response towards Th2. The purpose of this study is to determine the activity of Th2 immune response by measuring total serum IgE level during symptomatic and asymptomatic HIV infection with and without helminths co-infection and to define the role of deworming and/or ART on kinetics of serum IgE. METHODS: This prospective comparative study was conducted among symptomatic HIV-1 infected adults, treatment naïve asymptomatic HIV positive individuals and HIV negative apparently healthy controls with and without helminths co-infection. Detection and quantification of helminths and determination of serum IgE level, CD4(+), and CD8(+) T cell count were done at baseline and 12 weeks after ART and/or deworming. RESULTS: HIV patients co-infected with helminths showed a high level of serum IgE compared to HIV patients without helminths co-infection (1,688 [IQR 721-2,473] versus 1,221 [IQR 618-2,289] IU/ml; P = 0.022). This difference was also markedly observed between symptomatic HIV infected patients after with and without helminths infection (1,690 [IQR 1,116-2,491] versus 1,252 [703-2,251] IU/ml; P = 0.047). A significant decline in serum IgE level was observed 12 weeks after deworming and ART of symptomatic HIV infected patients with (1,487 versus 992, P = 0.002) and without (1,233 versus 976 IU/ml, P = 0.093) helminths co-infection. However, there was no significant decrease in serum IgE level among asymptomatic HIV infected individuals (1,183 versus 1,097 IU/ml, P = 0.13) and apparently health controls (666 IU/ml versus 571, P = 0.09) without helminths co-infection 12 weeks after deworming. CONCLUSIONS: The significant decline of serum IgE level 12 weeks after deworming of both symptomatic and asymptomatic patients indicate a tendency to down-regulate the Th2 immune response and is additional supportive evidence that deworming positively impacts HIV/AIDS diseases progression. Thus, deworming should be integrated with ART program in helminths endemic areas of tropical countries.

Quadruple burden of HIV/AIDS, tuberculosis, chronic intestinal parasitoses, and multiple micronutrient deficiency in ethiopia: a summary of available findings.

Human immunodeficiency virus (HIV), tuberculosis (TB), and helminthic infections are among the commonest public health problems in the sub-Saharan African countries like Ethiopia. Multiple micronutrient deficiencies also known as the "hidden hunger" are common in people living in these countries either playing a role in their pathogenesis or as consequences. This results in a vicious cycle of multiple micronutrient deficiencies and infection/disease progression. As infection is profoundly associated with nutritional status resulting from decreased nutrient intake, decreased nutrient absorption, and nutrient losses, micronutrient deficiencies affect immune system and impact infection and diseases progression. As a result, micronutrients, immunity, and infection are interrelated. The goal of this review is therefore to provide a summary of available findings regarding the "quadruple burden trouble" of HIV, TB, intestinal parasitic infections, and multiple micronutrient deficiencies to describe immune-modulating effects related to disorders.

Safety and efficacy of single dose versus multiple doses of AmBisome for treatment of visceral leishmaniasis in eastern Africa: a randomised trial.

BACKGROUND: Anti-leishmanial drug regimens that include a single dose AmBisome could be suitable for eastern African patients with symptomatic visceral leishmaniasis (VL) but the appropriate single dose is unknown. METHODOLOGY: A multi-centre, open-label, non-inferiority, randomized controlled trial with an adaptive design, was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome for the treatment of VL in eastern Africa. The primary efficacy endpoint was definitive cure (DC) at 6 months. Symptomatic patients with parasitologically-confirmed, non-severe VL, received a single dose of AmBisome 7.5 mg/kg body weight or multiple doses, 7 times 3 mg/kg on days 1-5, 14, and 21. If interim analyses, evaluated 30 days after the start of treatment following 40 or 80 patients, showed the single dose gave significantly poorer parasite clearance than multiple doses at the 5% significance level, the single dose was increased by 2·5 mg/kg. In a sub-set of patients, parasite clearance was measured by quantitative reverse transcriptase (qRT) PCR. PRINCIPAL FINDINGS: The trial was terminated after the third interim analysis because of low efficacy of both regimens. Based on the intention-to-treat population, DC was 85% (95%CI 73-93%), 40% (95%CI 19-64%), and 58% (95%CI 41-73%) in patients treated with multiple doses (n = 63), and single doses of 7·5 (n = 21) or 10 mg/kg (n = 40), respectively. qRT-PCR suggested superior parasite clearance with multiple doses as early as day 3. Safety data accorded with the drug label. CONCLUSIONS: The tested AmBisome regimens would not be suitable for VL treatment across eastern Africa. An optimal single dose regimen was not identified. TRIALS REGISTRATION: www.clinicaltrials.govNCT00832208.

Changing Trends in Prevalence and Antibiotics Resistance of Uropathogens in Patients Attending the Gondar University Hospital, Northwest Ethiopia.

Background. In most hospitals of developing countries, urinary tract infections are treated empirically because of lack of culture facilities. This leads to emergence of multiresistant uropathogens. Culturing and drug susceptibility testing are essential to guide therapy. Objectives. To assess changing prevalence and resistance pattern of uropathogens to commonly used antibiotics in a two-year study period. Methods. Urine specimens were collected and cultured. Uropathogens were identified by standard methods and tested for antibiotics resistance. Data were analyzed using SPSS version 16 statistical sofware. P value < 0.05 was considered statistically significant. Results. The commonest isolates in both the previous and present studies were E. coli, Klebsiella, CoNS, S. aureus, Proteus, and Citrobacter species. Previous isolates of Enterobacteriaceae were 100% sensitive to ciprofloxacin, whereas present isolates developed 31% to 60% resistance to it. Previous isolates were less resistant to gentamycin than the present ones. Multiresistance isolates were predominant in present study than previous ones. Conclusion. E. coli was predominant in the two study periods. Present isolates were more resistant than previous ones. Some previous isolates were 100% sensitive to ciprofloxacin, whereas present isolates were increasingly resistant. Ciprofloxacin and gentamicin have been recommended for empiric treatment of urinary tract infections.

Polymorphism in the HASPB repeat region of East African Leishmania donovani strains.

BACKGROUND/OBJECTIVES: Visceral leishmaniasis (VL) caused by Leishmania donovani is a major health problem in Ethiopia. Parasites in disparate regions are transmitted by different vectors, and cluster in distinctive genotypes. Recently isolated strains from VL and HIV-VL co-infected patients in north and south Ethiopia were characterized as part of a longitudinal study on VL transmission. METHODOLOGY/PRINCIPAL FINDINGS: Sixty-three L. donovani strains were examined by polymerase chain reaction (PCR) targeting three regions: internal transcribed spacer 1 (ITS1), cysteine protease B (cpb), and HASPB (k26). ITS1- and cpb--PCR identified these strains as L. donovani. Interestingly, the k26--PCR amplicon size varied depending on the patient's geographic origin. Most strains from northwestern Ethiopia (36/40) produced a 290 bp product with a minority (4/40) giving a 410 bp amplicon. All of the latter strains were isolated from patients with HIV-VL co-infections, while the former group contained both VL and HIV-VL co-infected patients. Almost all the strains (20/23) from southwestern Ethiopia produced a 450 bp amplicon with smaller products (290 or 360 bp) only observed for three strains. Sudanese strains produced amplicons identical (290 bp) to those found in northwestern Ethiopia; while Kenyan strains gave larger PCR products (500 and 650 bp). High-resolution melt (HRM) analysis distinguished the different PCR products. Sequence analysis showed that the k26 repeat region in L. donovani is comprised of polymorphic 13 and 14 amino acid motifs. The 13 amino acid peptide motifs, prevalent in L. donovani, are rare in L. infantum. The number and order of the repeats in L. donovani varies between geographic regions. CONCLUSIONS/SIGNIFICANCE: HASPB repeat region (k26) shows considerable polymorphism among L. donovani strains from different regions in East Africa. This should be taken into account when designing diagnostic assays and vaccines based on this antigen.

Sodium stibogluconate (SSG) & paromomycin combination compared to SSG for visceral leishmaniasis in East Africa: a randomised controlled trial.

BACKGROUND: Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India. METHODS: A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4-60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data. FINDINGS: The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200 patients respectively. The SSG & PM versus SSG comparison enrolled 381 and 386 patients per arm respectively, with primary efficacy data available for 359 patients per arm. In Intention-to-Treat complete-case analyses, the efficacy of PM was significantly lower than SSG (84.3% versus 94.1%, difference = 9.7%, 95% confidence interval, CI: 3.6 to 15.7%, p = 0.002). The efficacy of SSG & PM was comparable to SSG (91.4% versus 93.9%, difference = 2.5%, 95% CI: -1.3 to 6.3%, p = 0.198). End of treatment efficacy results were very similar. There were no apparent differences in the safety profile of the three treatment regimens. CONCLUSION: The 17 day SSG & PM combination treatment had a good safety profile and was similar in efficacy to the standard 30 day SSG treatment, suggesting suitability for VL treatment in East Africa. CLINICAL TRIALS REGISTRATION: www.clinicaltrials.govNCT00255567.

HIV-Positive Status Disclosure and Associated Factors among Children in North Gondar, Northwest Ethiopia.

Introduction. Clinical reports have indicated positive outcomes associated with disclosure of HIV-positive status in children. This study assessed the level and associated factors of HIV-positive status disclosure to HIV-infected children in northwest Ethiopia. Methods. Institution-based cross-sectional study was conducted among HIV-positive children from March to April 2012. Data were collected using a structured questionnaire by face-to-face interview technique. Bivariate and multivariate analyses were performed. Results. Of the 428 children, 169 (39.5%) were disclosed their HIV-positive status. The mean age of HIV-positive status disclosure was at 10.7 (±2.3) years. Having a nonbiological parent (AOR = 4.14, 95% CI: 1.22, 14.04), child's age older than 10 years (AOR = 8.54, 95% CI: 4.5, 15.53), and death of a family member (AOR = 2.04, 95% CI: 1.16, 3.6) were significantly and independently associated with disclosure of HIV-positive status to infected children. Conclusions. The rate of disclosure of HIV-positive status to infected children still remains low in North Gondar. Hence, it is important to target children living with their biological parents and having young parents and children younger than 10 years. The guideline for disclosure of children with HIV/AIDS should be established in an Ethiopian context.

Intestinal parasitosis and shigellosis among diarrheal patients in Gondar teaching hospital, northwest Ethiopia.

BACKGROUND: Diarrheal diseases are the major causes of morbidity and mortality in developing world. Understanding the etiologic agents of diarrheal diseases and their association with socio-demographic characteristics of patients would help to design better preventive measures. Thus, this study was aimed to determine the prevalence of intestinal parasites and enteropathogenic bacteria in diarrheic patients. METHODS: A cross-sectional study involving 384 consecutive diarrheal patients who visited Gondar teaching hospital, Gondar, Ethiopia from October 2006 to March 2007 was conducted. Stool specimens were collected and examined for intestinal parasites and enteropathogenic bacteria following standard parasitological and microbiological procedures. RESULTS: Intestinal parasites were diagnosed in 36.5% of the patients. The most frequently encountered protozoan parasite was Entamoeba histolytica/dispar (7.3%) followed by Giardia lamblia (5.0%), Cryptosporidium parvum (1.8%) and Isospora belli (1.3%). The dominant helminthic parasite identified was Ascaris lumbricoides (5.5%) followed by Strongyloides stercoralis and Schistosoma mansoni (3.1% each), hookworm infection (1.8%), and Hymenolepis species (1.3%). Multiple infections of intestinal parasites were also observed in 6.3% of the patients. Among the enteropathogenic bacteria Shigella and Salmonella species were isolated from 15.6% and 1.6%, respectively, of the patients. Escherichia coli O57:H7 was not found in any of the stool samples tested. Eighty eight percent and 83.3% of the Shigella and Salmonella isolates were resistant to one or more commonly used antibiotics, respectively.Intestinal parasitosis was higher in patients who live in rural area, in patients who were washing their hands after visiting toilet either irregularly with soap and without soap or not at all, in patients who used well and spring water for household consumption, and in patients who had nausea (P < 0.05). Statistically significant associations were also observed between Shigella infections and patients who were using well and spring water for household consumption, and patients who had dysentery and mucoid stool (P < 0.05). CONCLUSIONS: The high prevalence of intestinal parasites and Shigella species in diarrheic patients calls for institution of appropriate public health intervention measures to reduce morbidity and mortality associated with these diseases. The rational use of antibiotics should also be practiced.

Single-dose liposomal amphotericin B (AmBisome®) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial.

BACKGROUND: AmBisome® is an efficacious, safe anti-leishmanial treatment. There is growing interest in its use, either as a single dose or in combination treatments. In East Africa, the minimum optimal single-dosage has not been identified. METHODS/DESIGN: An open-label, 2-arm, non-inferiority, multi-centre randomised controlled trial is being conducted to determine the optimal single-dose treatment with AmBisome®.Patients in the single-dose arm will receive one infusion on day 1, at a dose depending on body weight. For the first group of patients entered to the trial, the dose will be 7.5 mg/kg, but if this dose is found to be ineffective then in subsequent patient series the dose will be escalated progressively to 10, 12.5 and 15 mg/kg. Patients in the reference arm will receive a multi-dose regimen of AmBisome® (3 mg/kg/day on days 1-5, 14 and 21: total dose 21 mg/kg). Patients will be hospitalised for approximately one month after the start of treatment and then followed up at three and six months. The primary endpoint is the status of patients six months after treatment. A secondary endpoint is assessment at day 30. Treatment success is determined as the absence of parasites on microscopy samples taken from bone marrow, lymph node or splenic aspirates. Interim analyses to assess the comparative efficacy of the single dose are planned after recruitment of 20 and 40 patients per arm. The final non-inferiority analysis will include 120 patients per arm, to determine if the single-dose efficacy 6 months after treatment is not more than 10% inferior to the multi-dose. DISCUSSION: An effective, safe single-dose treatment would reduce hospitalization and treatment costs. Results will inform the design of combination treatment studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT00832208.

Geographical variation in the response of visceral leishmaniasis to paromomycin in East Africa: a multicentre, open-label, randomized trial.

BACKGROUND: Visceral leishmaniasis (VL) is a major health problem in developing countries. The untreated disease is fatal, available treatment is expensive and often toxic, and drug resistance is increasing. Improved treatment options are needed. Paromomycin was shown to be an efficacious first-line treatment with low toxicity in India. METHODS: This was a 3-arm multicentre, open-label, randomized, controlled clinical trial to compare three treatment regimens for VL in East Africa: paromomycin sulphate (PM) at 15 mg/kg/day for 21 days versus sodium stibogluconate (SSG) at 20 mg/kg/day for 30 days; and the combination of both dose regimens for 17 days. The primary efficacy endpoint was cure based on parasite-free tissue aspirates taken 6 months after treatment. FINDINGS: Overall, 135 patients per arm were enrolled at five centres in Sudan (2 sites), Kenya (1) and Ethiopia (2), when the PM arm had to be discontinued due to poor efficacy. The trial has continued with the higher dose of PM as well as the combination of PM and SSG arms. These results will be reported later. Baseline patient characteristics were similar among treatment arms. The overall cure with PM was significantly inferior to that with SSG (63.8% versus 92.2%; difference 28.5%, 95%CI 18.8% to 38.8%, p<0.001). The efficacy of PM varied among centres and was significantly lower in Sudan (14.3% and 46.7%) than in Kenya (80.0%) and Ethiopia (75.0% and 96.6%). No major safety issues with PM were identified. CONCLUSION: The efficacy of PM at 15 mg/kg/day for 21 days was inadequate, particularly in Sudan. The efficacy of higher doses and the combination treatment warrant further studies.

Safety and effectiveness of meglumine antimoniate in the treatment of Ethiopian visceral leishmaniasis patients with and without HIV co-infection.

In sub-Saharan Africa, visceral leishmaniasis (VL) is treated with either Pentostam(TM) (sodium antimony gluconate) or generic sodium stibogluconate (SSG), except in Uganda where Glucantime(®) (meglumine antimoniate) has been in use for at least a decade. Between January 2008 and February 2009, 54 Ethiopian VL patients were treated with Glucantime. The medical charts of these patients were reviewed to assess the effectiveness and safety profile of Glucantime in a routine healthcare setting. None of the patients from south Ethiopia (n=24) and 46.4% of the patients from north Ethiopia (n=30) were HIV co-infected. At completion of treatment (Day 31), cure rates were 78.6% (95% CI 59.0-91.7%) in north Ethiopia and 100% (95% CI 85.8-100%) in south Ethiopia. Thirty-three non-serious and six serious adverse events (two pancreatitis, one renal failure and three deaths) were observed in 26 patients. One-third of the non-serious adverse events were due to biochemical pancreatitis. During treatment, a case-fatality rate of 10.0% in north Ethiopia and 0.0% in south Ethiopia was noted. These data show that Glucantime can be as effective as Pentostam or SSG in HIV-negative patients. The data also point to clinical pancreatitis as a safety concern, especially in patients with HIV co-infection.

Risk factors and case management of acute diarrhoea in North Gondar Zone, Ethiopia.

In Ethiopia, evidence is lacking about maternal care-taking and environmental risk factors that contribute to acute diarrhoea and the case management of diarrhoea. The aim of this study was to identify the risk factors and to understand the management of acute diarrhoea. A pretested structured questionnaire was used for interviewing mothers of 440 children in a prospective, matched, case-control study at the University of Gondar Referral and Teaching Hospital in Gondar, Ethiopia. Results of multivariate analysis demonstrated that children who were breastfed and not completely weaned and mothers who were farmers were protective factors; risk factors for diarrhoea included sharing drinking-water and introducing supplemental foods. Children presented with acute diarrhoea for 3.9 days with 4.3 stools per day. Mothers usually did not increase breastmilk and other fluids during diarrhoea episodes and generally did not take children with diarrhoea to traditional healers. Incorporating messages about the prevention and treatment of acute diarrhoea into child-health interventions will help reduce morbidity and mortality associated with this disease.