Monitoring malaria in Mozambique
Plasmodium Falciparum Molecular Surveillance in Mozambique to Monitor Markers of Antimalarial Drug Resistance, Rapid Tests Diagnostic Failure and Transmission in Mozambique: Phase 2
Centro de Investigacao em Saude de Manhica · NCT06529237
This study is trying to improve how we track and control malaria in Mozambique by using genetic information to help protect children and pregnant women from the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 18750 (estimated) |
| Ages | 6 Months and up |
| Sex | All |
| Sponsor | Centro de Investigacao em Saude de Manhica (other) |
| Locations | 1 site (Manhiça, Maputo Province) |
| Trial ID | NCT06529237 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance Molecular Malaria Surveillance (MMS) in Mozambique to optimize public health strategies against malaria. It focuses on real-time tracking of malaria transmission and drug resistance, utilizing genomic data to inform the National Malaria Control Program's strategies from 2023 to 2030. The study will involve children and pregnant women, assessing diagnostic effectiveness and therapeutic resistance through rapid diagnostic tests and molecular markers. By identifying transmission sources and improving vector control, the project seeks to implement targeted interventions for malaria control.
Who should consider this trial
Good fit: Ideal candidates for this study include children aged 2-10 years with fever and positive malaria tests, as well as pregnant women attending their first antenatal care visit.
Not a fit: Patients who are not residents of the study area or those with severe malaria symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this project could significantly improve malaria control strategies and reduce the burden of malaria in Mozambique.
How similar studies have performed: Other studies have shown success with similar molecular surveillance approaches in malaria control, indicating the potential effectiveness of this methodology.
Eligibility criteria
Show full inclusion / exclusion criteria
A) CHILDREN AT HEALTH FACILITIES Inclusion Criteria: * Informed, written consent to participate from the guardian * Children 2-10 years of age * Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours * At least one positive parasitological test for malaria diagnosis via RDT (HRP2 or LDH) Exclusion Criteria: * Unwilling to provide informed, written consent * Age \<2 years or \>10 years * not resident in study area * Any symptoms of severe malaria * Negative of both (HRP2 and LDH) parasitological test for malaria via RDT * History of antimalarial treatment in the last 14 days B) PREGNANT WOMEN AT ANC Inclusion Criteria: * Pregnant women attending first antenatal care visit * Resident in the study area * Pregnant Women older than 12 years old * Informed, written consent to participate from participant and/or guardian Exclusion Criteria: * Unwilling to provide informed, written consent * Not resident in study area * Any symptoms of severe malaria C) DENSE SAMPLING Inclusion Criteria: * People \> 6 months of age * Fever (axillary temperature ≥37.5ºC) or history of fever in the preceding 24 hours * Positive parasitological test for malaria diagnosis via RDT * Informed, written consent to participate from participant and/or guardian Exclusion Criteria: * Any symptoms of severe malaria * Negative parasitological test for malaria via RDT * Unwilling to provide informed, written consent * History of antimalarial treatment in the last 14 days
Where this trial is running
Manhiça, Maputo Province
- Centro de Investigaçao em Saúde de Manhiça — Manhiça, Maputo Province, Mozambique (RECRUITING)
Study contacts
- Study coordinator: Alfredo Mayor, Professor
- Email: alfredo.mayor@isglobal.org
- Phone: +34 686444183
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, Falciparum Malaria, Malaria in Pregnancy, drug resistance, Diagnostic resistance, Surveillance, Genomics, Importation