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

Duke University

Status and phase: Enrolling; Phase 4

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

Treatments: Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT); Drug: Artemether-lumefantrine (AL)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05757167

1U01AI162463-01A1 (U.S. NIH Grant/Contract)

5U01AI162463-03 (U.S. NIH Grant/Contract)

5U01AI162463-04 (U.S. NIH Grant/Contract)

5U01AI162463-02 (U.S. NIH Grant/Contract)

Pro00110771

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: Female

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,500 participants in 2 patient groups

HS-RDT screening/AL treatment

Experimental group

Description:

Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine

Treatment:

Drug: Artemether-lumefantrine (AL)

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

Usual antenatal care

No Intervention group

Description:

Pregnant women will receive usual antenatal care