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Safety And Antimicrobial Resistance of Mass Administration of Azithromycin In Children 1 - 59 Months In Nigeria: A type III hybrid effectiveness implementation study design using the RE-AIM framework

Safety And Antimicrobial Resistance of Mass Administration of Azithromycin In Children 1 - 59 Months In Nigeria: A type III hybrid effectiveness implementation study design using the RE-AIM framework

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603768509836
Enrollment
13743977
Registered
2026-03-19
Start date
2024-05-05
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatrics

Interventions

Azithromycin AZM

Sponsors

Gates Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A. Eligibility Criteria for MDA, Coverage Evaluation Survey (CES) and Community based Antimicrobial Resistance Assessment Community eligibility criteria Inclusion criteria: 1. The communities located in target states. 2. Relevant stakeholder’s permission and ethical approval to conduct the study 3. The community leader’s permission for study conduct. Individual eligibility criteria 1. All children in the study communities aged 1-59 months old during the study period irrespective of sex, ethnicity, and socioeconomic status 2. The ability of the children to tolerate oral feeds. B. Eligibility Criteria for Facility Based AMR assessment Children aged 1-59 months presenting with a non-malarial fever greater than 37.5°C, with (out) diarrhoea (passage of loose stools 4 episodes per day) or with (out) symptoms of respiratory tract infections (RTIs) (cough, fast breathing and/or difficulty in breathing) or with (out) symptoms of urinary tract infection (painful urination, frequency or urgency) C. Eligibility Criteria for Mortality Assessment: Women of Reproductive Age between 15 and 49 years

Exclusion criteria

Exclusion criteria: A. Community Exclusion criteria: 1. Community with significant security challenges Individual Exclusion criteria: 1. Children less than 3kg of body weight 2. Individuals allergic to macrolide based antibiotics 3. Those who appear to be ill B. Children aged 1-59 months presenting with fever but confirmed malaria test positive C. Women less than 15 years or greater than 49 years Non-consenting mothers and Head of Households

Design outcomes

Primary

MeasureTime frame
1. All cause under-5 mortality 2. Azithromycin antimicrobial resistance

Secondary

MeasureTime frame
1. Safety profile of AZM MDA among children 1-59 months 2. Treatment coverage 3. Facilitators and barriers to adoption, integration, and sustainability of AZM MDA as a child survival strategy 4. Implementation adaptation tracker

Countries

Nigeria

Contacts

Public ContactAdesola Zaidat Musa

Deputy Director Research Nigerian Institute of Medical Research

zaidatmusa@gmail.com+2348033430791

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026