Clinical Trial

Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics

Study acronym: INTREPiD
Active, Not Recruiting Phase 4
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Summary
The purpose of the INTREPiD study is to compare 1st trimester screening for malaria parasites with a high-sensitivity malaria rapid diagnostic test followed by treatment of test-positive women with artemether-lumefantrine (AL) against usual antenatal care on a composite adverse pregnancy outcome including low birth weight, small for gestational age, preterm, fetal loss, or neonatal death.
Protocol Amendment History 4 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-08
notable Enrollment reduced: 2500 -> 2174 participants 2026-05-08
notable Primary completion moved earlier: 2027-02 -> 2026-12 2026-05-08
minor Completion moved earlier: 2027-02 -> 2026-12 2026-05-08
Trial Details
NCT Number NCT05757167
Lead Sponsor Duke University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Malaria,Falciparum, Malaria in Pregnancy, Malaria in Childbirth, Pregnancy, Neonatal Health, Low Birthweight, Stillbirth, Gestational Age and Weight Conditions +1 more
Enrollment 2,174 participants
Start Date 2023-11-06
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-07