Intermittent preventive treatment of malaria in infants
MULTIple Doses of IPTi Proposal: a Lifesaving High Yield Intervention
Barcelona Institute for Global Health · NCT05085340
This study is testing if giving a malaria prevention treatment to infants under two years old can help reduce the number of malaria cases and hospital visits in sub-Saharan Africa.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45000 (estimated) |
| Ages | 10 Weeks to 18 Months |
| Sex | All |
| Sponsor | Barcelona Institute for Global Health (other) |
| Locations | 3 sites (Manhiça and 2 other locations) |
| Trial ID | NCT05085340 on ClinicalTrials.gov |
What this trial studies
This observational study aims to implement Perennial Malaria Chemoprevention (PMC) through the Expanded Program on Immunization (EPI) in sub-Saharan Africa, targeting infants under two years old. The intervention involves administering sulfadoxine-pyrimethamine (SP) to reduce the incidence of malaria, anemia, and hospital admissions in this vulnerable population. Conducted in Sierra Leone, Mozambique, and Togo, the study will enroll approximately 45,000 children over two years, focusing on those eligible for routine immunizations. The study seeks to evaluate the safety and efficacy of this preventive treatment in real-world settings.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under two years old attending their second EPI contact who are eligible for immunizations.
Not a fit: Patients who have acute malaria, known sulfa allergies, or have taken SP in the past four weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce malaria-related morbidity and mortality in infants in high-risk regions.
How similar studies have performed: Previous studies have shown that similar approaches to malaria prevention in infants have been effective, particularly in Sierra Leone where IPTi has been implemented.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All infants attending their 2nd EPI contact who are eligible to receive the corresponding immunisations. Exclusion Criteria: Infants/children; with acute malaria; known to have sulfa allergies; who have taken SP in the past 4 weeks; who are HIV-exposed or HIV-infected
Where this trial is running
Manhiça and 2 other locations
- Fundaçao Manhiça — Manhiça, Mozambique (RECRUITING)
- College of Medicine & Allied Health Sciences (COMAHS), University of Sierra Leone — Freetown, Sierra Leone (RECRUITING)
- University of Lomé — Lomé, Togo (RECRUITING)
Study contacts
- Principal investigator: Clara Menéndez, MD, PhD — Barcelona Institute for Global Health
- Study coordinator: Cristina Raya, MA
- Email: cristina.raya@isglobal.org
- Phone: +34 93 227 5400
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.
Conditions: Malaria, IPTi, Sulfadoxine-pyrimethamine, IPTi-SP, chemoprevention, Intermittent preventive treatment of malaria in infants, children, EPI