Paediatrics
Conditions
Interventions
MASS ADMINISTRATION OF AZITHROMYCIN
Sponsors
Bill and Melinda Gate Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. Community eligibility criteria Inclusion criteria: • The community located in target states. • The community leader’s permission for study conduct. B. Individual eligibility criteria Inclusion criteria: • All children in the study communities aged 1-11months old during the study period • The ability of the children to tolerate oral feeds • The family intends to stay within the study area for the duration of the study
Exclusion criteria
Exclusion criteria: Community Exclusion criteria: • Community with significant security challenges Individual Exclusion criteria: • Children less than 3kg of body weight • Children unable to take orally • Individuals allergic to antibiotics • Those who appear to be ill
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcomes: 1.Incidence of serious adverse events (SAE) and adverse events (AE) within 7-14 days of study drug administration. AMR outcomes: Phenotypic macrolide resistance among Streptococcus pneumoniae, K. pneumoniae, and S. aureus in the nasopharyngeal samples and E. coli, Salmonella spp. and Shigella spp strains isolated from stool samples among 1-11 month-old children, at 0, 6, 12, 18 and 24 months during MDA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality outcome: Mortality (deaths / 1000 years at risk) among children who were 1-11 months old at the time of study drug administration, based on a birth history approach or similar as used in routine population-based surveys such as Demographic Health Surveys. Cost and cost-effectiveness outcomes: Cost per child treated and cost per death averted. Cost data will be collected following an ingredients approach, based on a semi-structured questionnaire and by consultation of the programme accounting system. The work will also present an analysis of the full cost of scaled programme in all high-mortality states in Nigeria. Feasibility and acceptability outcomes: A qualitative evaluation will seek to identify and describe key assumptions and conditions underlying the implementation, sustainability and scaling-up of the different delivery approaches. Investigation will focus on (i) feasibility, including a situation and stakeholder analysis of the structural, organizational and management factors that enhance or constrain effective implementation, and (ii) community acceptability | — |
Countries
Nigeria
Contacts
Public ContactAdesola Zaidat Musa
Chief Research Fellow Nigerian Institute of Medical Research
Outcome results
None listed