Cross-sectional health centre and community-based evaluation of the impact of pneumococcal and malaria vaccination on antibiotic prescription and usage, febrile illness and antimicrobial resistance in young children in Malawi: the IVAR study protocol.

INTRODUCTION: Vaccination is a potentially critical component of efforts to arrest development and dissemination of antimicrobial resistance (AMR), though little is known about vaccination impact within low-income and middle-income countries. This study will evaluate the impact of vaccination on reducing carriage prevalence of resistant Streptococcus pneumoniae and extended spectrum beta-lactamase-producing Escherichia coli and Klebsiella species. We will leverage two large ongoing cluster-randomised vaccine evaluations in Malawi assessing; first, adding a booster dose to the 13-valent pneumococcal conjugate vaccine (PCV13) schedule, and second, introduction of the RTS,S/AS01 malaria vaccine. METHODS AND ANALYSIS: Six cross-sectional surveys will be implemented within primary healthcare centres (n=3000 users of outpatient facilities per survey) and their local communities (n=700 healthy children per survey): three surveys in Blantyre district (PCV13 component) and three surveys in Mangochi district (RTS,S/AS01 component). We will evaluate antibiotic prescription practices and AMR carriage in children ≤3 years. For the PCV13 component, surveys will be conducted 9, 18 and 33 months following a 3+0 to 2+1 schedule change. For the RTS,S/AS01 component, surveys will be conducted 32, 44 and 56 months post-RTS,S/AS01 introduction. Six health centres in each study component will be randomly selected for study inclusion. Between intervention arms, the primary outcome will be the difference in penicillin non-susceptibility prevalence among S. pneumoniae nasopharyngeal carriage isolates in healthy children. The study is powered to detect an absolute change of 13 percentage points (ie, 35% vs 22% penicillin non-susceptibility). ETHICS AND DISSEMINATION: This study has been approved by the Kamuzu University of Health Sciences (Ref: P01-21-3249), University College London (Ref: 18331/002) and University of Liverpool (Ref: 9908) Research Ethics Committees. Parental/caregiver verbal or written informed consent will be obtained prior to inclusion or recruitment in the health centre-based and community-based activities, respectively. Results will be disseminated via the Malawi Ministry of Health, WHO, peer-reviewed publications and conference presentations.

Development of bioelectrical impedance-based equations for the prediction of body composition of Malawian adolescents aged 10-18 years: a cross-sectional study.

OBJECTIVES: The accuracy of bioelectrical impedance analysis (BIA) depends on population-specific prediction equations and there is no population-specific equation for predicting fat-free mass (FFM) in Malawian adolescents. This study aimed at determining the agreement between FFM measured by deuterium oxide dilution technique (the reference) and FFM by BIA; and propose BIA-based prediction equations to estimate FFM for Malawian adolescents. DESIGN: This was a cross-sectional study. SETTING: The study was conducted in Blantyre, Malawi PARTICIPANTS: 186 Malawian adolescents aged between 10 and 18 years were included in this study. Body composition was estimated by both the BodyStat BIA analyser and the deuterium oxide dilution method. RESULTS: BIA inbuilt equation underestimated FFM compared with deuterium oxide dilution (p=0.039). The new prediction equation for FFM (kg)=-4.316+ 0.425* height2(cm)/resistance (Ω)+1.287* sex (male=1, female=0)+0.307*age(years)+0.344* weight(kg)+0.019*reactance(Ω) yielded an R2 of 0.926. The equation for total body water (TBW) (kg)=-2.152 + 0.328*height2(cm)/resistance (Ω) 0.910*sex (male=1, female=0)+0.307 *age (years)+0.249*weight(kg)+0.015*reactance(Ω) yielded an R2 of 0.922. The Bland-Altman plot illustrated a good level of concordance between the FFM and TBW predicted by the new equations and the values derived using deuterium dilution method. CONCLUSIONS: The new BIA prediction equations for estimating FFM and TBW could be used to assess with very good accuracy and precision the body composition of Malawian and adolescents with similar characteristics.