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Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

ABSTRACT: BACKGROUND:Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger. METHODS AND PRINCIPAL FINDINGS:Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported. CONCLUSIONS:Azithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective. TRIAL REGISTRATION:ClinicalTrials.gov NCT02048007.

SUBMITTER: Oldenburg CE

PROVIDER: S-EPMC6258425 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

Oldenburg Catherine E CE Arzika Ahmed M AM Maliki Ramatou R Kane Mohamed Salissou MS Lebas Elodie E Ray Kathryn J KJ Cook Catherine C Cotter Sun Y SY Zhou Zhaoxia Z West Sheila K SK Bailey Robin R Porco Travis C TC Keenan Jeremy D JD Lietman Thomas M TM

PLoS neglected tropical diseases 20181112 11

<h4>Background</h4>Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger.<h4>Methods and principal findings</h4>Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large c ...[more]

PMID: 30419040

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Project description:Introduction:Practicing exclusive breastfeeding (EBF) in an infant's first six months of life is recommended by the World Health Organization because of its proven effectiveness as a method to support the infant's short- and long-term physical and cognitive development. However, many countries, including Cambodia, face contextually driven challenges in meeting this optimum standard of breastfeeding. The recent declining EBF rate in Cambodia is a concerning indicator of the impact of these challenges. Methods:We used existing data from the 2014 Cambodian Demographic and Health Survey (CDHS) to analyze 717 Cambodian mother-infant pairs. CDHS 2014 used a two-stage stratified cluster sampling approach to select samples. A multivariable logistic regression analysis was used to assess determinants of EBF, taking into account the sampling weight in the analysis. Adjusted odds ratios (AOR) with 95% confidence intervals (CI) were calculated, and significance level was considered at p value < 0.05. Results:Our findings indicate that among mothers with infants under six months, EBF was more likely if they resided rurally (AOR = 2.28; 95% CI 1.23-4.23) and if they delivered at a public hospital (AOR = 2.64; 95% CI 1.28-5.47). On the other hand, mothers of middle wealth index practiced EBF less than mothers of low wealth index (AOR = 0.58; 95% CI 0.34-0.99). And as expected, our analysis confirmed that the older the infants grew, the less likely they were to be exclusively breastfed than those younger than one month old (2-3 months: AOR = 0.49; 95% CI 0.26-0.92; 4-5 months: AOR = 0.25; 95% CI 0.15-0.43). Conclusion:The findings emphasize the need to address these determinants adequately by appropriate interventions to halt the declining trend of EBF practice. We recommend a multifaceted approach to improve EBF rates in Cambodia. Advocacy around EBF at public hospitals should continue, and private hospital staff should receive training to provide EBF counselling and support to mothers.

Project description:IntroductionExclusive breastfeeding (EBF) is the safest and healthiest option of feeding among infants in the first 6 months throughout the world. Thus, the promotion of EBF is essential to prevent complex infant health problems even at the adulthood level. But the majority of previous studies focused on individual- level determinants of EBF by using basic regression models in localized areas. This study aimed to identify the determinants of EBF at the individual and community level which would be helpful to design appropriate strategies for improving the practice of EBF.MethodsIt is a secondary data analysis using the 2016 Ethiopian Demographic and Health Survey (EDHS) data. A total of 1185 infants under 6 months of age were included in the analysis. A Multilevel logistic regression model was employed to investigate factors significantly associated with EBF among under-six infants in Ethiopia. Adjusted odds ratio (AOR) with 95% confidence interval (CI) was used to measure the association of variables whereas Intracluster correlation (ICC), median odds ratio (MOR), and proportional change in variance (PCV) were used to measure random effects (variation).ResultIn multilevel logistic regression; 4-5 months age infant (AOR = 0.04, 95%CI:0.02-0.07), female infants (AOR = 2.51, 95%CI:1.61-3.91), infant comorbidities (AOR = 0.35, 95%CI: 0.21-0.57), richest household wealth index (AOR = 10.34, 95%CI: 3.14-34.03) and antenatal care (AOR = 2.25, 95%CI:1.32-3.82) were individual- level determinants significantly associated with exclusive breastfeeding. Whereas, contextual region (AOR = 0.30, 95%CI: 0.10-0.87), community- level of postnatal visit (AOR = 2.77, 95%CI: 1.26-6.58) and community -level of maternal employment (AOR = 2.8, 95%CI: 1.21-6.47) were community level determinants significantly associated with EBF. The full model showed that46.8% of the variation of exclusive breastfeeding was explained by the combined factors at the individual and community levels. Similarly, it showed that the variation in exclusive breastfeeding across communities remained statistically significant (ICC = 8.77% and variance = 0.32 with P<0.001).Conclusion and recommendationOur study showed that both individual and community level determinants were significantly associated with EBF practice among under 6 infants. Based on our findings, it is recommended to promote and enhance antenatal and postnatal care services utilization of mothers to improve exclusive breastfeeding practice and more emphasis should be given to infants with comorbid conditions and those who were living in the pastoralist regions.

Project description:BackgroundIn the past two decades, there has been a growing recognition of the need to establish indigenous standards or reference growth charts, particularly following the WHO multicenter growth study in 2006. The availability of accurate and reliable growth charts is crucial for monitoring child health. The choice of an appropriate model for constructing growth charts depends on various data characteristics, including the distribution's tails and peak. While Pakistan has reported some reference growth charts, there is a notable absence of indigenous charts for children under two years of age, especially for infants aged 0-6 months who are exclusively breastfed. Additionally, acquiring data poses a significant challenge, particularly for low-income countries, as it demands substantial resources such as finances, time, and expertise. The Multiple Indicator Cluster Survey (MICS) constitutes a large-scale national survey conducted periodically in low-income countries under the auspices of UNICEF. In this study, we propose methods for generating selection variables utilizing the "Novel Case Selection Method," as previously published. Further our approach enables to select and fit appropriate model to the MICS data, selected, and to develop the standard growth charts.MethodsOut of the 11,478 children under 6 months of age included in MICS-6 (Pakistan), 3,655 children (1,831 males and 1,824 females) met the specified criteria and were selected using the "Novel Case Selection Method". The sample was distributed across provinces as follows: 841 (23.0%) from KPK, 1,464 (40.1%) from Punjab, 819 (22.4%) from Sindh, and 531 (14.5%) from Balochistan. This sample encompassed both rural (76.4%) and urban (23.6%) populations. Following data cleaning and outlier removal, a total of 3,540 records for weight (1,768 males and 1,772 females) and 3,515 records for height (1,759 males and 1,756 females) were ultimately available for the development of standard charts. The Bayesian Information Criterion (BIC) was employed to determine the optimal degrees of freedom for L, M, and S using RefCurv_0.4.2. Three families within the gamlss class-namely, Box Cox Cole and Green (BCCG), Box Cox T (BCT), and Box Cox Power Exponential (BCPE)-were applied, each with three smoothing techniques: penalized splines (ps), cubic splines (cs), and polynomial splines (poly). The best-fitted model was selected from these nine combinations based on the Akaike Information Criteria.ResultsThe Novel Case Selection Method yielded 3655 cases as per criteria. After cleaning the data, this method lead to selection of 3540 children for "weight for age" (W/A) and 3515 children for "height for age" (H/A). The "BCPE" family and "ps" as smoothing method proved to be best on AIC for all four curves, i.e. the W/A male, W/A female, H/A male, and H/A female. The optimum selected degrees of freedom for the curve "W/A", for both genders were (M = 1, L = 0, S = 0). The optimum degrees of freedom for H/A male were again (M = 1, L = 0, S = 0), but for females the selected degrees of freedom were (M = 1, L = 1, S = 1). The indigenous fitted standard curves for Pakistan were on lower trajectory in comparison to WHO standards.ConclusionThis study uses the Novel Case Selection Method with introduced algorithms to construct tailored growth charts for lower and middle-income countries. Leveraging extensive MICS data, the methodology ensures representative national samples. The resulting charts hold practical value and await validation from established data sources, offering valuable tools for policy makers and clinicians in diverse global contexts.

Project description:BackgroundBiannual distribution of azithromycin to children 1-59 months old reduced mortality by 14% in a cluster-randomized trial. The World Health Organization has proposed targeting this intervention to the subgroup of children 1-11 months old to reduce selection for antimicrobial resistance. Here, we describe a trial designed to determine the impact of age-based targeting of biannual azithromycin on mortality and antimicrobial resistance.MethodsAVENIR is a cluster-randomized, placebo-controlled, double-masked, response-adaptive large simple trial in Niger. During the 2.5-year study period, 3350 communities are targeted for enrollment. In the first year, communities in the Dosso region will be randomized 1:1:1 to 1) azithromycin 1-11: biannual azithromycin to children 1-11 months old with placebo to children 12-59 months old, 2) azithromycin 1-59: biannual azithromycin to children 1-59 months old, or 3) placebo: biannual placebo to children 1-59 months old. Regions enrolled after the first year will be randomized with an updated allocation based on the probability of mortality in children 1-59 months in each arm during the preceding study period. A biannual door-to-door census will be conducted to enumerate the population, distribute azithromycin and placebo, and monitor vital status. Primary mortality outcomes are defined as all-cause mortality rate (deaths per 1000 person-years) after 2.5 years from the first enrollment in 1) children 1-59 months old comparing the azithromycin 1-59 and placebo arms, 2) children 1-11 months old comparing the azithromycin 1-11 and placebo arm, and 3) children 12-59 months in the azithromycin 1-11 and azithromycin 1-59 arms. In the Dosso region, 50 communities from each arm will be followed to monitor antimicrobial resistance. Primary resistance outcomes will be assessed after 2 years of distributions and include 1) prevalence of genetic determinants of macrolide resistance in nasopharyngeal samples from children 1-59 months old, and 2) load of genetic determinants of macrolide resistance in rectal samples from children 1-59 months old.DiscussionAs high-mortality settings consider this intervention, the results of this trial will provide evidence to support programmatic and policy decision-making on age-based strategies for azithromycin distribution to promote child survival.Trial registrationThis trial was registered on January 13, 2020 (clinicaltrials.gov: NCT04224987 ).

Dataset Information

Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

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Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.

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