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

Study acronym: INTREPiD
StatusActive, Not Recruiting
PhasePhase 4
Started2023-11-06
View on ClinicalTrials.gov ↗

Amendment history

2026-05-06
Study Status, Study Design, Contacts/Locations v11
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 2500 → 2174 participants
Primary completion moved earlier: 2027-02 → 2026-12
Completion moved earlier: 2027-02 → 2026-12
Study sitesdetails revised at 2 of 2 sites
2026-01-16
Study Status v10
Primary completion date2026-11-30→2027-02
Completion date2026-11-30→2027-02
2025-05-15
Study Identification, Study Status, Arms and Interventions v9
Primary completion date2026-10-09→2026-11-30
Completion date2026-10-09→2026-11-30
InterventionsArtemether-Lumefantrine 20 Mg-120 Mg Oral Tablet (Drug), Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) (Diagnostic Test)→Artemether-lumefantrine (AL) (Drug), Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) (Diagnostic Test)
2025-01-23
Study Status v8
Primary completion date2026-10→2026-10-09
Completion date2026-10→2026-10-09
2024-11-12
Study Status v7
Primary completion date2026-04→2026-10
Completion date2026-04→2026-10
Show 6 earlier versions
2024-05-17
Study Status v6
Primary completion date2025-12→2026-04
Completion date2025-12→2026-04
2024-01-23
Study Status v5
Primary completion date2025-02→2025-12
Completion date2025-02→2025-12
2023-11-09
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11→confirmed 2023-11-06
Study sitesdetails revised at 2 of 2 sites
2023-10-25
Study Status v3
Start date2023-09→2023-11
2023-08-16
Study Status v2
Start date2023-07→2023-09
2023-05-11
Study Status v1
Start date2023-04→2023-07
2023-02-24
Original filing
Duke University
455 trials monitored
See 53 trials at risk
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.
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