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RECRUITING
NCT05757167
PHASE4

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

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Official title: Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity

Key Details

Gender

FEMALE

Age Range

16 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2023-11-06

Completion Date

2027-02

Last Updated

2026-01-20

Healthy Volunteers

No

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

Locations (2)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Moi University

Eldoret, Kenya