NCT05757167View on ClinicalTrials.gov

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

PHASE4RecruitingINTERVENTIONAL
Enrollment

2,500

Participants

Timeline

Start Date

November 6, 2023

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Malaria,FalciparumMalaria in PregnancyMalaria in ChildbirthPregnancyNeonatal HealthLow BirthweightStillbirthGestational Age and Weight ConditionsPreterm Birth
Interventions
DIAGNOSTIC_TEST

Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)

"Detection of Plasmodium falciparum HRP-II antigen1~Method: Lateral Flow; Time to Result: 20 minutes; Sample Type: Fingerstick Whole Blood; Sample Volume: 5µl; Storage Conditions: 1-30°C; Shelf Life: 12 months; Sensitivity/Specificity: 99.0%/98.6%"

DRUG

Artemether-lumefantrine (AL)

oral tablets: 6 doses of 80/480 mg over 3 days

Trial Locations (2)

Unknown

RECRUITING

Kinshasa School of Public Health, Kinshasa

RECRUITING

Moi University, Eldoret

Sponsors

Lead Sponsor

Duke University
All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Duke University

OTHER

NCT05757167 - Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics | Biotech Hunter | Biotech Hunter