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

January 23, 2024 updated by: Duke University

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

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.

Study Overview

Detailed Description

INTREPiD is a two-arm, open-label, parallel-assignment randomized trial of a strategy of 1st trimester screening for P. falciparum parasites with a high-sensitivity rapid diagnostic test (HS-RDT). Participants will be women of all gravidities presenting to antenatal clinics in the 1st trimester in sites endemic for P. falciparum malaria in Kenya and the Democratic Republic of the Congo.

Following consent and enrollment, women will be allocated 1:1 to either usual antenatal care or to the intervention. The intervention will be a single screening in the 1st trimester for P. falciparum infection in maternal peripheral blood with a HS-RDT. Women who test positive for P. falciparum on HS-RDT testing will be treated with a single course of Artemether-Lumefantrine (AL) and then returned to usual antenatal care.

Participants will be followed through delivery and then through their offspring's first month of life.

The Hypothesis is that, compared to usual antenatal care, screening women in the 1st trimester for P. falciparum and treating them if positive with AL will reduce the risk of an adverse pregnancy outcome.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 16 years and 40 years (inclusive)
  • Viable singleton pregnancy with gestational age estimated less than 13 6/7 weeks (inclusive) by ultrasound
  • HIV-uninfected
  • Willing to participate in the study schedule
  • Planning to remain in the study area for the duration of pregnancy and 1 month after delivery
  • Willing to deliver in a study-affiliated health facility

Exclusion Criteria:

  • High risk pregnancy that requires referral for specialized care by local guidelines
  • Active medical problem at the time of screening requiring higher level care
  • Antimalarial receipt in the 2 weeks prior to screening
  • Past allergy to Artemether or Lumefantrine or another condition that prohibits the receipt of either drug
  • Current participation in another clinical research study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS-RDT screening/AL treatment
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine

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%

Other Names:
  • NxTek™ Eliminate Malaria P.f
  • 05FK140 (Global)
  • 05FK141 (Global)
  • 05FK142 (Global)
  • 05FK143 (Global)
  • Alere Malaria Ag P.f
oral tablets: 6 doses of 80/480 mg over 3 days
Other Names:
  • Coartem
  • AL
No Intervention: Usual antenatal care
Pregnant women will receive usual antenatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite number of adverse pregnancy outcomes
Time Frame: Enrollment to 28 days Post-delivery (including each antenatal care visit)
Adverse pregnancy outcomes defined as low birth weight (<2500 grams) OR preterm (< 37 0/7 weeks) OR small for gestational age (GA) (< 10th percentile weight for GA) OR pregnancy loss, defined as a. spontaneous abortion ( loss < 22 0/7 weeks gestation) OR b. stillbirth (loss ≥ 22 0/7 weeks gestation) OR neonatal death (livebirth with death prior to the 28th day of life).
Enrollment to 28 days Post-delivery (including each antenatal care visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Birthweight
Time Frame: Delivery
Birthweight in grams
Delivery
Number of infants with low birthweight
Time Frame: Delivery
< 2500 grams, livebirth
Delivery
Gestational age (GA)
Time Frame: Delivery
GA at delivery in weeks/days, livebirth
Delivery
Preterm
Time Frame: Delivery
< 37 0/7 weeks, livebirth
Delivery
Number of infants that are small for gestational age
Time Frame: Delivery
Weight for gestational age < 10th percentile, livebirth
Delivery
Number of adverse newborn outcomes
Time Frame: Delivery
low birthweight OR preterm OR small for gestational age
Delivery
Number of spontaneous abortions
Time Frame: Delivery
Pregnancy loss < 22 0/7 weeks gestation
Delivery
Number of stillbirths
Time Frame: Delivery
Pregnancy loss ≥ 22 0/7 weeks gestation
Delivery
Number of early fetal deaths
Time Frame: Delivery
Pregnancy loss 22 0/7 - 27 6/7 weeks gestation
Delivery
Number of late fetal deaths
Time Frame: Delivery
Pregnancy loss ≥ 28 0/7 weeks gestation
Delivery
Number of pregnancy losses
Time Frame: Delivery
Spontaneous abortion OR stillbirth
Delivery
Number of neonatal deaths
Time Frame: Delivery to 28 days Post-delivery
Before the 28th day of life, livebirth
Delivery to 28 days Post-delivery
Number of perinatal deaths
Time Frame: Delivery to 28 days Post-delivery
Late fetal death OR Neonatal death
Delivery to 28 days Post-delivery
Incidence of clinical malaria during pregnancy
Time Frame: Enrollment to Delivery (including each antenatal care visit)
Maternal symptoms with peripheral malaria parasitemia detected by light microscopy or rapid diagnostic test
Enrollment to Delivery (including each antenatal care visit)
Number of mothers with peripheral parasitemia at delivery
Time Frame: Delivery
Maternal peripheral parasitemia at delivery by PCR
Delivery
Mean maternal hemoglobin concentration
Time Frame: Enrollment and Delivery
Maternal hemoglobin (g/dL)
Enrollment and Delivery
Number of mothers with anemia at delivery
Time Frame: Delivery
Maternal Hb concentration ≤ 11 g/dL
Delivery
Number of mothers with severe anemia at delivery
Time Frame: Delivery
Maternal Hb concentration ≤ 7 g/dL
Delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of maternal serious adverse events
Time Frame: Enrollment to 28 days Post-delivery
Serious adverse events in the mothers
Enrollment to 28 days Post-delivery
Number of infants with congenital malformations
Time Frame: Delivery to 28 days Post-delivery
Congenital malformations identified within the first 28 days of birth
Delivery to 28 days Post-delivery
Number of offspring with the need for hospitalization or acute medical evaluation
Time Frame: Delivery to 28 days Post-delivery
Hospitalization or acute medical evaluation within the first 28 days of life
Delivery to 28 days Post-delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Steve M Taylor, MD, MPH, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 24, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Estimated)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT)

Subscribe