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

NCT05757167 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2174

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Malaria,Falciparum
  • Malaria in Pregnancy
  • Malaria in Childbirth
  • Pregnancy
  • Neonatal Health
  • Low Birthweight
  • Stillbirth
  • Gestational Age and Weight Conditions
  • Preterm 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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Steve M Taylor, MD, MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Democratic Republic of the Congo
  • Kenya

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05757167 on ClinicalTrials.gov