ABSTRACT
Dengue poses a significant public health concern worldwide. It is identified as a recent emerging infectious disease in Nepal. Understanding the situation and dynamics between knowledge, attitudes, and practices (KAP) related to dengue among students is crucial for effective prevention and control strategies. This study aimed to assess the KAP and their associated factors of dengue among non-health undergraduate students of Nepal to identify gaps and suggest appropriate interventions. A web-based cross-sectional study was conducted among 429 non-health undergraduate students at eleven Nepalese Universities, with 80% of participants from the four most prominent ones in the country. Self-administered online forms were administered via Google Forms platform predominantly through social media for data collection. Data was cleaned and then exported to IBM SPSS Statistics 20.0 for analysis. Demographic characteristics of respondents were described using descriptive statistics. Multivariate logistic regression was conducted to determine the association between individual characteristics and KAP. Pearson's correlation coefficient was used to determine the association between knowledge-attitude, attitude-practice, and knowledge-practice. Statistical significance was determined at the P-value < 0.05. Around half of the participants were female (50.3%). The majority of participants were between 22 to 37 years, unmarried, and belonged to the Brahmin/Chhetri ethnic group. This study demonstrated a significant gap in KAP. Only 15.2% of participants had good knowledge while 25.9% and 68.3% of participants exhibited good attitudes and practices respectively. Marital status (AOR = 3.32, CI: 1.32-8.34), third-year educational level (AOR = 3.59, CI:1.34-9.57), and fourth-year educational level (AOR = 4.93, CI:1.88-12.94) were significantly associated with knowledge regarding dengue. Age (AOR = 1.73, CI: 1.10-3.01) was significantly associated with preventive practice regarding dengue. None of the demographic or socio-economic characteristics of respondents was associated with attitude on dengue. The knowledge-attitude (rka = 0.01), knowledge-practice (rkp = 0.22), and attitude-practice (rap = 0.01) were positively correlated in this study.
Subject(s)
Dengue , Health Knowledge, Attitudes, Practice , Students , Humans , Dengue/prevention & control , Dengue/epidemiology , Female , Male , Nepal/epidemiology , Adult , Cross-Sectional Studies , Young Adult , Students/psychology , Surveys and Questionnaires , Universities , AdolescentABSTRACT
Four noncommunicable diseases (NCDs): cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes, account for 71% of global deaths. However, little is known about the NCDs risk profile of sexual and gender minorities (SGMs). This study aimed to determine the prevalence of NCDs risk factors among the SGMs of Kathmandu valley, Nepal. A cross-sectional study was conducted among SGMs in the Kathmandu valley, Nepal. We recruited 140 participants using the snowball sampling method. A face-to-face interview was done using a structured questionnaire adapted from World Health Organization Step Wise Approach to Surveillance (STEPS instruments V2.2 2019) along with blood pressure and anthropometric measurements. Data were analyzed using Statistical Package for Social Science (SPSS.v20). More than two-thirds of the participants, 96 (68.6%), had co-occurrence of NCDs risk factors. The prevalence of insufficient fruits and vegetables consumption, current smoking, harmful alcohol consumption, overweight/obesity, and hypertension were 95.7%, 40.0%, 32.9%, 28.5%, and 28.6%, respectively. There was a significant association between hypertension, harmful alcohol consumption, and overweight/obesity with the participants' age, employment status, and marital status, respectively. Study findings indicated a higher prevalence of NCDs risk factors among SGMs. National-level NCDs surveillance, policy planning, prevention, and targeted health interventions should prioritize the SGMs.
Subject(s)
Alcoholism , Hypertension , Noncommunicable Diseases , Humans , Overweight/epidemiology , Prevalence , Nepal/epidemiology , Noncommunicable Diseases/epidemiology , Cross-Sectional Studies , Risk Factors , Obesity/epidemiology , Hypertension/epidemiologyABSTRACT
Depression is one of the most common mental disorders, affecting 300 million people worldwide and 75% of these occur in low- and middle-income countries. Persons with physical disabilities are vulnerable groups and are more prone to experience depressive symptoms than the general population. This study investigated the prevalence of depressive symptoms and the associated factors among persons with a physical disability. We conducted a concurrent triangulation mixed methods design using Beck's Depression Inventory scale among 162 persons with physical disabilities in the Kathmandu district. In parallel, eight in-depth interviews were conducted with an interview guideline to collect the participants' perceptions and experiences of disability. Both quantitative and qualitative findings were integrated into the results. We found that about 77% of the participants with a physical disability had experienced depressive symptoms. Unemployment status (adjusted odds ratio (AOR) 2.7, 95% confidence interval (CI) 1.0-7.3) and comorbidity (AOR 2.5, 95% CI 1.0-6.0) had a statistically significant association with depressive symptoms. The majority of people with physical disabilities had negative experiences with societal prejudice and coping with their limitations. They were depressed as well as angry over having to stop their careers, education, and possibilities. Nevertheless, they were significantly happier and less sad than in their earlier years of life because of the possibilities, family environment, improved means of subsistence, therapeutic facilities, and supportive atmosphere at disability care homes. The policymakers should focus on preventing comorbidity and providing technical skills to persons with physical disabilities to improve their employment status and promote a healthy lifestyle.
ABSTRACT
Consumption of mad honey can lead to intoxication. The exact incidence of mad honey-induced intoxication is unknown. Typically, the patients present with dizziness, nausea, syncope, and sinus bradycardia. Case presentation: The authors reported the case of a middle-aged male patient who presented with blurring of vision, passage of loose stools, vomiting, and profuse sweating after ingestion of honey. He also had a history of loss of consciousness. On presentation, he was hypotensive and tachypneic with cold, clammy extremities. His ECG showed sinus bradycardia. The authors made a diagnosis of mad honey intoxication with suspected anaphylaxis. The authors treated him with intravenous normal saline, epinephrine, and atropine. He again developed hypotension and bradycardia in a few hours, for which hydrocortisone was administered, following which his heart rate was normalized in 2 h. Overall, the recovery time in our patient was 8 h. The patient was counseled to avoid consuming mad honey and did well on his monthly follow-up. Discussion: Our patient had signs and symptoms suggesting intoxication following ingestion of mad honey with suspicion of anaphylaxis. Similar to other reported cases, the patient had sinus bradycardia and hypotension. Epinephrine and atropine were administered to treat hypotension and bradycardia, respectively. Also, refractory hypotension was managed by intravenous hydrocortisone. Usually, atropine and saline infusion are sufficient to manage these cases, and simultaneous use of epinephrine and atropine should be avoided unless indicated. Conclusion: Our case highlighted the approach to diagnosing and treating mad honey intoxication with suspected anaphylaxis.
ABSTRACT
In the past few decades, the Nepali government has endorsed several nutritional policies, strategies, and guidelines. Given the lack of a comprehensive review of such policy documents, this review aims to describe the nutrition and food security policies and understand the existing policy gaps in Nepal. Findings from this study can be used to develop policies and programs to address Nepal's current and future nutritional needs. Policies relevant to nutrition and food security were identified by searching government websites and directly approaching relevant government ministries. Thematic analysis was conducted using framework methods under 8 predetermined themes: nutrition intervention, food security, food system, capacity building of human resources, nutrition education, nutrition governance, research, and monitoring and evaluation. The contents of each document reviewed were manually extracted in a spreadsheet stratified by the themes, and the findings were summarized for the respective themes. A total of 30 policy documents were reviewed. Most policies have focused on undernutrition; only a few have addressed overnutrition and diet-related noncommunicable diseases. Food security through a sustainable food system has been considered a key policy area in Nepal. Other areas in the food and nutrition policy landscape are capacity building for human resources, behavior change practices, nutrition governance, monitoring, and evaluation. Policy gaps have been identified in the quality and sustainability of nutrition programs; access to health care services; competent human resources for nutrition; intersectoral coordination and commitment; and support for monitoring, evaluation, and research activities. Most policies have tried to address a wide range of components of food and nutrition security; however, strategies focused on overnutrition and diet-related noncommunicable diseases are lacking. Several gaps are identified in this policy review; the findings can guide the policymakers to address these gaps via further policy development.
Subject(s)
Noncommunicable Diseases , Overnutrition , Humans , Nepal , Nutritional Status , Nutrition Policy , Food SecurityABSTRACT
The population of Nepal is rapidly aging, as in other low and middle-income countries, and the number of individuals living with Alzheimer's Disease and related dementias (ADRD) is expected to increase. However, information about the neuropsychological assessment of ADRD in Nepal is lacking. We first aimed to examine the needs, challenges, and opportunities associated with the neuropsychological assessment of older adults in Nepal for population-based ADRD ascertainment. Second, we introduce the Chitwan Valley Family Study-Study of Cognition and Aging in Nepal (CVFS-SCAN), which is poised to address these needs, and its collaboration with the Harmonized Cognitive Assessment Protocol (HCAP) international network. We reviewed the existing literature on the prevalence, risk factors, available neuropsychological assessment instruments, and sociocultural factors that may influence the neuropsychological assessment of older adults for ADRD ascertainment in Nepal. Our review revealed no existing population-based data on the prevalence of ADRD in Nepal. Very few studies have utilized formal cognitive assessment instruments for ADRD assessment, and there have been no comprehensive neuropsychological assessment instruments that have been validated for the assessment of ADRD in Nepal. We describe how the CVFS-SCAN study will address this need through careful adaptation of the HCAP instrument. We conclude that the development of culturally appropriate neuropsychological assessment instruments is urgently needed for the population-based assessment of ADRD in Nepal. The CVFS-SCAN is designed to address this need and will contribute to the growth of global and equitable neuropsychology and to the science of ADRD in low- and middle-income countries.
Subject(s)
Alzheimer Disease , Dementia , Humans , Aged , Dementia/diagnosis , Dementia/epidemiology , Nepal/epidemiology , Alzheimer Disease/epidemiology , Aging , Neuropsychological TestsABSTRACT
INTRODUCTION: The construction industry in Nepal, which employs a significant proportion of the population, ranks as one of the largest industries in the country. Construction work is physically demanding and can be risky due to the use of heavy machinery and the presence of intense physical labor. However, the physical and mental health of construction workers in Nepal is often neglected. This study aimed to assess psychological distress (depression, anxiety, and stress symptoms) and its association with socio-demographic, lifestyle, and occupational factors among construction workers in Kavre district, Nepal. METHODS: We conducted a cross-sectional study from 1st October 2019 to 15th January 2020 among 402 construction workers in Banepa, and Panauti municipalities of Kavre district, Nepal. We collected data with face-to-face interviews using a structured questionnaire consisting of a) socio-demographic characteristics; b) lifestyle and occupational characteristics; and c) depression, anxiety and stress symptoms. We collected data using electronic forms in KoboToolbox and imported them into R version 3.6.2 for statistical analysis. We present parametric numerical variables as mean and standard deviation, and categorical variables as percentage and frequency. The confidence interval around proportion was estimated with the Clopper-Pearson method. We applied univariate and multivariable logistic regression to determine factors associated with depression symptoms, anxiety, and stress. The result of logistic regression was presented as crude odds ratio, adjusted odds ratio (AOR), and their 95% confidence interval (CI). RESULTS: The prevalence of depression, anxiety and stress symptoms were 17.1% (95%CI: 13.6-21.2), 19.2% (95%CI: 15.5-23.4) and 16.4% (95%CI: 12.9-20.4), respectively. In multivariable logistic regression analysis, depression symptom was positively associated with poor sleep quality (AOR = 3.51; 95%CI: 1.5-8.19; p-value: 0.004); stress symptom was positively associated with Brahmin ethnicity (AOR = 3.76; 95%CI:1.34-10.58; p-value: 0.012) and current smoking (AOR = 2.0; 95%CI: 1.11-3.82 p-value: 0.022). But anxiety symptoms were not associated with any of the variables. CONCLUSIONS: The prevalence of depression, anxiety, and stress symptoms were high among construction workers. Developing evidence-based and appropriate community-based mental health prevention programs among laborers and construction workers is recommended.
Subject(s)
Construction Industry , Depression , Humans , Depression/epidemiology , Prevalence , Nepal/epidemiology , Cross-Sectional Studies , Anxiety/epidemiologyABSTRACT
BACKGROUND: Adolescence is a critical transition in human growth and adolescents tend to engage in various risky behaviors which are likely to continue into adulthood. Co-occurrence of non-communicable disease risk factors has the potential to increase risks of chronic disease comorbidity and increased mortality in later life. Behavioral risk factors are adopted due to changes in lifestyle and adolescents are more prone to acquire them. This study aimed to determine the prevalence and associated factors of co-occurrence of non-communicable disease risk factors among school-going adolescents of Kathmandu Metropolitan City. METHODS: We conducted a cross-sectional study among school-going adolescents of Kathmandu Metropolitan City in January/February 2020. We used stratified random sampling to select 1108 adolescents studying in 9, 10, 11, and 12 grades. We used Global Schools Health Survey tools to collect data. We entered data in EpiData 3.1 and exported it into Statistical Package for Social Science (SPSS) version 20 for statistical analysis. We estimated prevalence of NCDs risk factors and co-occurrence of risk factors. We applied multivariate multinomial logistic regression analysis adjusting for age, gender, ethnicity, religion, education, type of school, and parental education to determine factors associated with co-occurrence of NCDs risk factors. RESULTS: The prevalence of physical inactivity, unhealthy diet, harmful use of alcohol and tobacco among school-going adolescents were 72.3% (95%CI: 69.6-74.9), 41.1% (95%CI: 38.2-44.0), 14.8% (95%CI: 12.8-17.0) and 7.8% (95%CI:6.3-9.5) respectively. The adolescent with co-occurrence of two or more risk factors was 40.7% (95%CI: 37.8-43.7). The school-going adolescents who were in higher age group (AOR = 1.72, 95% CI- 1.06, 2.77), Hindus (AOR = 1.78, 95% CI-1.09, 2.89), other than Brahmin/Chhetri by ethnicity (AOR = 2.11, 95% CI-1.39, 2.22) and with lower education level of mothers (AOR = 2.40, 95% CI- 1.46,3.98) were more likely to have co-occurrence of NCDs risk factors after adjusting for all socio-demographic variables. CONCLUSION: The co-occurrence of non-communicable disease risk factors was high among school going adolescents and was associated with age, religion, ethnicity and mother's education. Integrated and comprehensive interventional programs should be developed by concerned authorities.
Subject(s)
Noncommunicable Diseases , Students , Adolescent , Cities/epidemiology , Comorbidity , Cross-Sectional Studies , Humans , Nepal/epidemiology , Noncommunicable Diseases/epidemiology , Prevalence , Risk Factors , Schools , Students/statistics & numerical dataABSTRACT
Introduction: Intensive lifestyle modification including a healthy diet changes the diagnostic status of patient from prediabetes to nondiabetes. In type 2 diabetes, improper eating habits increase insulin resistance. This study is aimed at assessing adherence to the dietary recommendation and its associated factors among people with type 2 diabetes. Methods: A cross-sectional descriptive study was conducted among systematically sampled type 2 diabetic patients using interview on Gandaki Medical College Teaching Hospital and Diabetes, Thyroid, and Endocrinology Care Center, Pokhara. The Perceived Dietary Adherence Questionnaire was used to assess dietary adherence. Data was entered in EpiData version 3.1 and analyzed on SPSS version 20. Logistic regression with adjusted odds ratio and the corresponding 95% confidence intervals were used to find out significance of association. Results: Among 204 participants, only 15.7% of the participants had good dietary adherence. The mean age and standard deviation were 53.03 ± 11.90 years. Factors such as participants living in single family (AOR 2.7, 95% CI 1.0-7.4), participants who could afford recommended diet (AOR 2.9, 95% CI 1.0-8.3), participants having self-control on food (AOR 4.1, 95% CI 1.2-14.1), participants who were engaged in moderate to heavy physical activities (AOR 3.3, 95% CI 1.2-9.2), and participants who had adherence to medication (AOR 3.5, 95% CI 1.2-10.1) were significantly associated with adherence to dietary recommendation. Conclusions: Adherence to dietary recommendation among people with type 2 diabetes was low. Factors such as family type, affordability of recommended diet, self-control on food, physical activity, and medication adherence were significantly associated with adherence to dietary recommendations among people with type 2 diabetes. These factors should be considered by nutrition counselors and clinical decision-makers in patient counseling regarding dietary adherence.
Subject(s)
Diabetes Mellitus, Type 2 , Humans , Cross-Sectional Studies , Nepal , Diet , Medication Adherence , EthiopiaABSTRACT
BACKGROUND: The co-existence of undernutrition and overnutrition is a global public health threat. We aim to report the burden of both nutritional deficiency (Protein-Energy Malnutrition) and overweight (high Body Mass Index) in Nepal over a decade (2010-2019) and observe the changes through trend charts. METHODS: We did a secondary data analysis using the Institute for Health Metrics and Evaluation (IHME)'s Global Burden of Disease (GBD) database to download age-standardized data on Protein Energy Malnutrition (PEM) and high Body Mass Index (BMI). We presented the trend of death, Disability Adjusted Life Years (DALYs), Years of Life Lost (YLL), and Years Lost due to Disability (YLD) of PEM and high BMI in Nepal from 2010 to 2019 and also compared data for 2019 among South Asian countries. RESULTS: Between 2010 and 2019, in Nepal, the Disability Adjusted Life Years (DALYs) due to PEM were declining while high BMI was in increasing trend. Sex-specific trends revealed that females had higher DALYs for PEM than males. In contrast, males had higher DALYs for high BMI than females. In 2019, Nepal had the highest death rate for PEM (5.22 per 100,000 populations) than any other South Asian country. The burden of PEM in terms of DALY was higher in under-five children (912 per 100,000 populations) and elderly above 80 years old (808.9 per 100,000 populations), while the population aged 65-69 years had the highest burden of high BMI (5893 per 100,000 populations). In the last decade, the DALYs for risk factors contributing to PEM such as child growth failure (stunting and wasting), unsafe water, sanitation and handwashing, and sub-optimal breastfeeding have declined in Nepal. On the contrary, the DALYs for risk factors contributing to high BMI, such as a diet high in sugar-sweetened beverages, a diet high in trans fatty acid, and low physical activity, have increased. This could be a possible explanation for the increasing trend of high BMI and decreasing trend of PEM. CONCLUSION: Rapidly growing prevalence of high BMI and the persistent existence of undernutrition indicate the double burden of malnutrition in Nepal. Public health initiatives should be planned to address this problem.
Subject(s)
Malnutrition , Protein-Energy Malnutrition , Trans Fatty Acids , Aged , Aged, 80 and over , Body Mass Index , Child , Female , Global Burden of Disease , Humans , Male , Nepal/epidemiology , Protein-Energy Malnutrition/epidemiologyABSTRACT
Low birth weight is still an important public health problem worldwide. It is a major contributor to neonatal death in developing countries, including Nepal. The government of Nepal has developed and implemented different programs to improve maternal and neonatal health, including baby's birth weight. However, low birth weight is a major maternal and child health challenge. Maternal factors determining the birth weight of neonates have been poorly assessed in previous studies in Nepal. Thus, this study aims to assess the prevalence and risk factors associated with low birth weight in Nepal. An institution-based descriptive cross-sectional study was carried out in Paropakar Maternity Hospital and Tribhuvan University Teaching Hospital of Kathmandu district among 308 postnatal mothers. The data was collected through the face-to-face interview technique. The data was entered in EpiData 3.1 and exported to Statistical Package and Service Solutions version 21 for analysis. Multivariate logistic regression was used to obtain an adjusted odds ratio, while p-value < 0.05 with 95% Confidence Interval (CI) was considered significant. The findings showed that 15.3% of the children had low birth weight. The mean and standard deviation of childbirth weight was 2.96±0.59 kg. Mothers belonged to Dalit ethnic (AOR = 2.9, 95% CI = 1.2-7.1), Antenatal Care visited three or fewer (AOR = 2.6, 95%CI = 1.0-6.6) and did not comply with Iron and Folic Acid supplementation (AOR = 2.1, 95% CI = 1.0-4.4) were significantly associated with low birth weight. Nearly one in every six children had low birth weight. Maternal health services such as antenatal care and compliance with a recommended dose of maternal micronutrients significantly impact on birth weight. Maternal and neonatal health programs should consider these factors to reduce adverse birth outcomes in Nepal.
ABSTRACT
Meat hygiene refers to all conditions and measures necessary to ensure safety and suitability of meat at all stages of the food chain. Inadequate hygiene practices allow consumers to be exposed to pathogens causing public health problems. Inadequate facilities and hygiene practices in meat shops results in meat contamination. The study aimed to identify factors associated with meat hygiene practices among meat handlers in the Metropolitan City of Kathmandu, Nepal. A cross-sectional study was designed with a semi-structured questionnaire and observation checklist that collected information about hygiene practices from 320 consenting meat-handlers by interviewer-administered technique. Data was entered in EpiData and analyzed using IBM SPSS version 21. Descriptive statistics of frequency distribution were used to report meat hygiene-practices and other independent variables, with multivariate logistic regression to establish predictors of meat hygiene-practices at 5% level of significance. The study revealed that less than half (44.4%) of the meat handlers had satisfactory meat hygiene practices. The adjusted regression analysis showed, strong evidence (p<0.01) of association of higher education level (AOR = 2.8, 95% CI = 1.7-4.5), other occupational involvement (AOR = 2.2, 95% CI = 1.9-2.4), and being officially registered (AOR = 2.8, 95% CI = 1.2-6.8) with meat hygiene practices. However, there was fair evidence (p<0.05) of association between shorter duration of meat being processed to sale (AOR = 0.57, P = 0.042) and meat hygiene practices. In this study, the satisfactory meat hygiene practices of meat handlers was low. The educational level, registration status of shops, involvement in other jobs, and awareness on meat hygiene were identified as key factors associated with meat hygiene practices. Thus, these factors need to be considered while developing programs to improve meat hygiene practices among the meat handlers. Meat handlers should be provided with training and orientation program for improving the meat hygiene practices.
ABSTRACT
As the current COVID-19 pandemic is evolving, skin lesions are being reported more, the most common skin manifestation being morbilliform rashes. We describe a patient of severe COVID-19 infection, 48-year-old who initially presented with fever, cough and constitutional symptoms who developed morbilliform macular rashes during his illness. The rash appeared on 6th day of illness in the trunk, arms with sparing of palms and soles, associated with itching. He later developed features of the cytokine-storm syndrome. The exact mechanism for the rashes is yet to be elaborated, however, it is postulated that it is either due to immune-mediated vasodilation or micro thrombosis secondary to low-grade-coagulopathy associated with COVID-19. Recognition of rashes as a feature of this disease is particularly significant to clinicians as it aids in early diagnosis, particularly in resource-poor countries. There is no evident association, however, between the severity and the rashes in COVID-19 infection.
Subject(s)
COVID-19 , Exanthema , Exanthema/diagnosis , Exanthema/etiology , Humans , Male , Middle Aged , Pandemics , Pruritus , SARS-CoV-2ABSTRACT
Infant and young child feeding is a key area to improve child survival and promote healthy growth and development. Nepal government has developed and implemented different programs to improve infant and young child feeding practice. However, the practice remains poor and is a major cause of malnutrition in Nepal. This study aims to identify infant and young child feeding practices and its associated factors among mothers of children aged less than two years in western hilly region of Nepal. A descriptive cross-sectional study was carried out among 360 mothers of under two years' children in Syangja district. A semi structural questionnaire was used. Data was entered in EpiData and analyzed using IBM SPSS version 21. Descriptive statistics were used to report the feeding practices and other independent variables. Bivariate and multivariate logistic regression model was used to establish the factors associated with infant and young child feeding practices. The prevalence of breastfeeding, timely initiation of breastfeeding, exclusive breastfeeding, timely initiation of complementary feeding, minimum dietary diversity, minimum meal frequency and minimum acceptable diet (MAD) were 95.6%, 69.2%, 47.6%, 53.3%, 61.5%, 67.3% and 49.9% respectively. Normal delivery (AOR 6.1, 95% CI 1.2-31.3) and higher maternal autonomy (AOR 5.2, 95% CI 1.8-14.6) were significantly associated with exclusive breastfeeding. Similarly, crop production and food security (AOR 3.8, 95% CI 1.9-7.7), maternal knowledge on MAD (AOR 2.5, 95% CI 1.0-6.2) and maternal autonomy (AOR 4.2, 95% CI 2.1-8.4) were significantly associated with minimum acceptable diet. Factors such as maternal education, maternal health services utilization, maternal knowledge, and maternal autonomy were associated with infant and young child feeding practices, which warrants further attention to these factors to reduce malnutrition.
Subject(s)
Government Programs/methods , Malnutrition/epidemiology , Mothers/education , Adult , Breast Feeding/statistics & numerical data , Child Nutritional Physiological Phenomena/physiology , Child, Preschool , Cross-Sectional Studies , Diet , Educational Status , Feeding Behavior/psychology , Female , Government Programs/trends , Humans , Infant , Infant Food/supply & distribution , Infant Nutritional Physiological Phenomena , Infant, Newborn , Male , Maternal Health Services , Meals , Nepal , Pregnancy , Socioeconomic Factors , Surveys and QuestionnairesABSTRACT
BACKGROUND: Because treatment with third-generation cephalosporins is associated with slow clinical improvement and high relapse burden for enteric fever, whereas the fluoroquinolone gatifloxacin is associated with rapid fever clearance and low relapse burden, we postulated that gatifloxacin would be superior to the cephalosporin ceftriaxone in treating enteric fever. METHODS: We did an open-label, randomised, controlled, superiority trial at two hospitals in the Kathmandu valley, Nepal. Eligible participants were children (aged 2-13 years) and adult (aged 14-45 years) with criteria for suspected enteric fever (body temperature ≥38·0°C for ≥4 days without a focus of infection). We randomly assigned eligible patients (1:1) without stratification to 7 days of either oral gatifloxacin (10 mg/kg per day) or intravenous ceftriaxone (60 mg/kg up to 2 g per day for patients aged 2-13 years, or 2 g per day for patients aged ≥14 years). The randomisation list was computer-generated using blocks of four and six. The primary outcome was a composite of treatment failure, defined as the occurrence of at least one of the following: fever clearance time of more than 7 days after treatment initiation; the need for rescue treatment on day 8; microbiological failure (ie, blood cultures positive for Salmonella enterica serotype Typhi, or Paratyphi A, B, or C) on day 8; or relapse or disease-related complications within 28 days of treatment initiation. We did the analyses in the modified intention-to-treat population, and subpopulations with either confirmed blood-culture positivity, or blood-culture negativity. The trial was powered to detect an increase of 20% in the risk of failure. This trial was registered at ClinicalTrials.gov, number NCT01421693, and is now closed. FINDINGS: Between Sept 18, 2011, and July 14, 2014, we screened 725 patients for eligibility. On July 14, 2014, the trial was stopped early by the data safety and monitoring board because S Typhi strains with high-level resistance to ciprofloxacin and gatifloxacin had emerged. At this point, 239 were in the modified intention-to-treat population (120 assigned to gatifloxacin, 119 to ceftriaxone). 18 (15%) patients who received gatifloxacin had treatment failure, compared with 19 (16%) who received ceftriaxone (hazard ratio [HR] 1·04 [95% CI 0·55-1·98]; p=0·91). In the culture-confirmed population, 16 (26%) of 62 patients who received gatifloxacin failed treatment, compared with four (7%) of 54 who received ceftriaxone (HR 0·24 [95% CI 0·08-0·73]; p=0·01). Treatment failure was associated with the emergence of S Typhi exhibiting resistance against fluoroquinolones, requiring the trial to be stopped. By contrast, in patients with a negative blood culture, only two (3%) of 58 who received gatifloxacin failed treatment versus 15 (23%) of 65 who received ceftriaxone (HR 7·50 [95% CI 1·71-32·80]; p=0·01). A similar number of non-serious adverse events occurred in each treatment group, and no serious events were reported. INTERPRETATION: Our results suggest that fluoroquinolones should no longer be used for treatment of enteric fever in Nepal. Additionally, under our study conditions, ceftriaxone was suboptimum in a high proportion of patients with culture-negative enteric fever. Since antimicrobials, specifically fluoroquinolones, are one of the only routinely used control measures for enteric fever, the assessment of novel diagnostics, new treatment options, and use of existing vaccines and development of next-generation vaccines are now a high priority. FUNDING: Wellcome Trust and Li Ka Shing Foundation.