Using Azithromycin to Reduce Child Mortality in Africa
Evaluation of the Impact on Childhood Mortality of Azithromycin Plus Intermittent Preventive Treatment Administered Through the Expanded Program on Immunization in Sierra Leone
This study is testing whether giving Azithromycin along with routine vaccinations can help reduce the number of babies who die before their second birthday in Sierra Leone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20560 (estimated) |
| Ages | 6 Weeks to 8 Weeks |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health Academic / other |
| Locations | 1 site (Freetown) |
| Trial ID | NCT04235816 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of administering Azithromycin as part of routine immunizations on reducing all-cause mortality in infants up to 18 months of age in Sierra Leone. The study will be a large-scale, individually randomized, placebo-controlled trial that assesses the effectiveness of Azithromycin alongside other preventive health interventions recommended by the WHO. It will also investigate potential antibiotic resistance, interactions with routine immunizations, and the overall safety and impact on the health system. The trial is designed to generate evidence to inform health policy and improve child survival rates in a region with high under-five mortality.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 18 months of age living in the study area whose parents or guardians can provide informed consent.
Not a fit: Patients who have known allergies to macrolides or sulfadoxine-pyrimethamine, or those with acute illnesses at the time of recruitment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce child mortality rates in Sierra Leone and similar regions.
How similar studies have performed: Other studies have shown promise with similar approaches in reducing child mortality through preventive treatments, making this a potentially impactful intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parents/guardians have signed the informed consent * Permanent residence in the study area-health facility catchment area * Without known allergies to or contraindications to macrolides * Without known allergies to or contraindications to SP * Agreement to complete the EPI scheme at the recruitment health facility * Parents/guardians agree to participate Exclusion Criteria: * Residence outside the study area or planning to move out in the following 12 months from enrolment * Known history of allergy or contraindications to macrolides and/or SP * Known history of allergy or contraindications to SP * With signs of any acute illness at the time of recruitment * Participating in other intervention studies
Where this trial is running
Freetown
- College of Medicine and Allied Health Sciences — Freetown, Sierra Leone (Recruiting)
Study contacts
- Study coordinator: Haily Chen, MSc.
- Email: haily.chen@isglobal.org
- Phone: +34 932275400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.