Assessing the effectiveness of a malaria prevention treatment in young children in Nigeria
A Study Protocol to Assess the Chemoprevention Efficacy of Sulphadoxine-Pyrimethamine Plus Amodiaquine (SPAQ) and Resistance Marker Prevalence in Children 3-59 Months in Sokoto and Kwara States, Nigeria.
This study is testing if a malaria prevention treatment called SPAQ can keep young children in Nigeria safe from malaria for 28 days.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 3 Months to 59 Months |
| Sex | All |
| Sponsor | Malaria Consortium Academic / other |
| Locations | 1 site (Kwara) |
| Trial ID | NCT05979896 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) in preventing malaria among children aged 3 to 59 months in Sokoto and Kwara States, Nigeria. It aims to determine if SPAQ can provide 28 days of protection against Plasmodium falciparum malaria infections and to assess the prevalence of drug resistance markers. The study will involve a prospective cohort design, where children will receive standard age-based dosing of SPAQ and undergo monitoring for malaria symptoms and drug resistance. The findings will help inform future malaria prevention strategies in the region.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 59 months who are residents of the study area and are currently afebrile with no recent malaria symptoms.
Not a fit: Patients who have symptoms of malaria, known allergies to SPAQ, or are receiving certain medications that interact with SPAQ will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce malaria incidence in young children, improving health outcomes in affected communities.
How similar studies have performed: Previous studies have shown promising results with similar chemoprevention approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Children between 3-59 months. * Being resident in the research study area. * Afebrile children with no other malaria associated symptoms in the past 48 hours or at time of recruitment. * Consent to participate in the study obtained. * Can comply with 3 days DOT of standard SPAQ regimen. * Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections. Exclusion criteria * Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours) * Known allergy to SPAQ. * Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole). * Individuals receiving azithromycin due to the antimalarial activity of azithromycin. * Severe malnutrition according to WHO guidelines * HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz) * Chronic illness of any kind. * Treatment with an ACT in previous 2 weeks. * Previous treatment with SPAQ this malaria season.
Where this trial is running
Kwara
- Kwara Sentinell Site — Kwara, Nigeria (Recruiting)
Study contacts
- Principal investigator: Craig Bonnington — Malaria Consortium
- Study coordinator: Craig Bonnington
- Email: C.BONNINGTON@MALARIACONSORTIUM.ORG
- Phone: +447597549279
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.