A Phase 4 interventional study of Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) and Artemether-lumefantrine (AL) in Malaria,Falciparum, Malaria in Pregnancy and Malaria in Childbirth, sponsored by Duke University. Active, not recruiting at 2 sites in 2 countries. Open to female participants aged 16 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Duke University · Phase 4, Interventional, and Screening
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.
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.
384 studies on the registry are indexed under Malaria, Falciparum; 38 are open to participants now.
This study's enrollment of 2,174 is above the median of 132 across 319 interventional studies indexed under Malaria, Falciparum.
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Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine
Diagnostic Test: Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) · Drug: Artemether-lumefantrine (AL)
Pregnant women will receive usual antenatal care
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%
Also known as: 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
Also known as: AL
Composite number of adverse pregnancy outcomes
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).
Time frame: Enrollment to 28 days Post-delivery (including each antenatal care visit)
Birthweight
Birthweight in grams
Time frame: Delivery
Number of infants with low birthweight
\< 2500 grams, livebirth
Time frame: Delivery
Gestational age (GA)
GA at delivery in weeks/days, livebirth
Time frame: Delivery
Preterm
\< 37 0/7 weeks, livebirth
Time frame: Delivery
Number of infants that are small for gestational age
Weight for gestational age \< 10th percentile, livebirth
Time frame: Delivery
Number of adverse newborn outcomes
low birthweight OR preterm OR small for gestational age
Time frame: Delivery
Number of spontaneous abortions
Pregnancy loss \< 22 0/7 weeks gestation
Time frame: Delivery
Number of stillbirths
Pregnancy loss ≥ 22 0/7 weeks gestation
Time frame: Delivery
Number of early fetal deaths
Pregnancy loss 22 0/7 - 27 6/7 weeks gestation
Time frame: Delivery
Number of late fetal deaths
Pregnancy loss ≥ 28 0/7 weeks gestation
Time frame: Delivery
Number of pregnancy losses
Spontaneous abortion OR stillbirth
Time frame: Delivery
Number of neonatal deaths
Before the 28th day of life, livebirth
Time frame: Delivery to 28 days Post-delivery
Number of perinatal deaths
Late fetal death OR Neonatal death
Time frame: Delivery to 28 days Post-delivery
Incidence of clinical malaria during pregnancy
Maternal symptoms with peripheral malaria parasitemia detected by light microscopy or rapid diagnostic test
Time frame: Enrollment to Delivery (including each antenatal care visit)
Number of mothers with peripheral parasitemia at delivery
Maternal peripheral parasitemia at delivery by PCR
Time frame: Delivery
Mean maternal hemoglobin concentration
Maternal hemoglobin (g/dL)
Time frame: Enrollment and Delivery
Number of mothers with anemia at delivery
Maternal Hb concentration ≤ 11 g/dL
Time frame: Delivery
Number of mothers with severe anemia at delivery
Maternal Hb concentration ≤ 7 g/dL
Time frame: Delivery
Number of maternal serious adverse events
Serious adverse events in the mothers
Time frame: Enrollment to 28 days Post-delivery
Number of infants with congenital malformations
Congenital malformations identified within the first 28 days of birth
Time frame: Delivery to 28 days Post-delivery
Number of offspring with the need for hospitalization or acute medical evaluation
Hospitalization or acute medical evaluation within the first 28 days of life
Time frame: Delivery to 28 days Post-delivery
Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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