Malaria Molecular Surveillance in Mozambique (Phase 2)

Recruiting

• Conditions: Malaria; Falciparum Malaria; Malaria in Pregnancy

• Registration Number: NCT06529237
• Lead Sponsor: Centro de Investigacao em Saude de Manhica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18750

Inclusion Criteria

A) CHILDREN AT HEALTH FACILITIES<br><br>Inclusion Criteria:<br><br> - Informed, written consent to participate from the guardian<br><br> - Children 2-10 years of age<br><br> - Fever (axillary temperature =37.5ºC) or history of fever in the preceding 24 hours<br><br> - At least one positive parasitological test for malaria diagnosis via RDT (HRP2 or<br> LDH)<br><br>Exclusion Criteria:<br><br> - Unwilling to provide informed, written consent<br><br> - Age <2 years or >10 years<br><br> - not resident in study area<br><br> - Any symptoms of severe malaria<br><br> - Negative of both (HRP2 and LDH) parasitological test for malaria via RDT<br><br> - History of antimalarial treatment in the last 14 days<br><br>B) PREGNANT WOMEN AT ANC<br><br>Inclusion Criteria:<br><br> - Pregnant women attending first antenatal care visit<br><br> - Resident in the study area<br><br> - Pregnant Women older than 12 years old<br><br> - Informed, written consent to participate from participant and/or guardian<br><br>Exclusion Criteria:<br><br> - Unwilling to provide informed, written consent<br><br> - Not resident in study area<br><br> - Any symptoms of severe malaria<br><br>C) DENSE SAMPLING<br><br>Inclusion Criteria:<br><br> - People > 6 months of age<br><br> - Fever (axillary temperature =37.5ºC) or history of fever in the preceding 24 hours<br><br> - Positive parasitological test for malaria diagnosis via RDT<br><br> - Informed, written consent to participate from participant and/or guardian<br><br>Exclusion Criteria:<br><br> - Any symptoms of severe malaria<br><br> - Negative parasitological test for malaria via RDT<br><br> - Unwilling to provide informed, written consent<br><br> - History of antimalarial treatment in the last 14 days

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of molecular markers of antimalarial resistance at provincial level;Prevalence of hrp2/3 deletions determined at regional level;Genetic diversity of the parasite population by period, study area and population;Genetic relatedness between pairs of samples and populations by period, study area and population;Genetic diversity in circumsporozoite protein C-terminal region encompassing T-cell epitopes