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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AI162463-01A1 | U.S. NIH Grant/Contract | View source | |
| 5U01AI162463-02 | U.S. NIH Grant/Contract | View source | |
| 5U01AI162463-03 | U.S. NIH Grant/Contract | View source | |
| 5U01AI162463-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-RDT screening/AL treatment | Experimental | Pregnant women will be screened with a malaria HS-RDT and, if positive, treated with artemether-lumefantrine |
|
| Usual antenatal care | No Intervention | Pregnant women will receive usual antenatal care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Malaria High-Sensitivity Rapid Diagnostic Test (HS-RDT) | Diagnostic Test | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Enrollment to 28 days Post-delivery (including each antenatal care visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Birthweight | Birthweight in grams | Delivery |
| Number of infants with low birthweight | < 2500 grams, livebirth | Delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of maternal serious adverse events | Serious adverse events in the mothers | Enrollment to 28 days Post-delivery |
| Number of infants with congenital malformations | Congenital malformations identified within the first 28 days of birth |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve M Taylor, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinshasa School of Public Health | Kinshasa | Democratic Republic of the Congo | ||||
| Moi University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24853593 | Background | Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19. | |
| 29396010 | Background | Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31. |
| Label | URL |
|---|---|
| Organization WH. Every Newborn: an action plan to end preventable deaths. | View source |
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Random assignment to either a) usual antenatal care or b) testing for malaria with a high-sensitivity rapid diagnostic test followed by treatment with artemether-lumefantrine if tested positive
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|
|
| Artemether-lumefantrine (AL) | Drug | oral tablets: 6 doses of 80/480 mg over 3 days |
|
|
| Gestational age (GA) | GA at delivery in weeks/days, livebirth | Delivery |
| Preterm | < 37 0/7 weeks, livebirth | Delivery |
| Number of infants that are small for gestational age | Weight for gestational age < 10th percentile, livebirth | Delivery |
| Number of adverse newborn outcomes | low birthweight OR preterm OR small for gestational age | Delivery |
| Number of spontaneous abortions | Pregnancy loss < 22 0/7 weeks gestation | Delivery |
| Number of stillbirths | Pregnancy loss ≥ 22 0/7 weeks gestation | Delivery |
| Number of early fetal deaths | Pregnancy loss 22 0/7 - 27 6/7 weeks gestation | Delivery |
| Number of late fetal deaths | Pregnancy loss ≥ 28 0/7 weeks gestation | Delivery |
| Number of pregnancy losses | Spontaneous abortion OR stillbirth | Delivery |
| Number of neonatal deaths | Before the 28th day of life, livebirth | Delivery to 28 days Post-delivery |
| Number of perinatal deaths | Late fetal death OR Neonatal death | 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 | Enrollment to Delivery (including each antenatal care visit) |
| Number of mothers with peripheral parasitemia at delivery | Maternal peripheral parasitemia at delivery by PCR | Delivery |
| Mean maternal hemoglobin concentration | Maternal hemoglobin (g/dL) | Enrollment and Delivery |
| Number of mothers with anemia at delivery | Maternal Hb concentration ≤ 11 g/dL | Delivery |
| Number of mothers with severe anemia at delivery | Maternal Hb concentration ≤ 7 g/dL | Delivery |
| 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 | Delivery to 28 days Post-delivery |
| Eldoret |
| Kenya |
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| 28032463 | Background | Clark RL, Youreneff M, DeLise AM. Developmental toxicity studies of lumefantrine and artemether in rats and rabbits. Birth Defects Res B Dev Reprod Toxicol. 2016 Dec;107(6):243-257. doi: 10.1002/bdrb.21189. |
| 20809964 | Background | Manyando C, Mkandawire R, Puma L, Sinkala M, Mpabalwani E, Njunju E, Gomes M, Ribeiro I, Walter V, Virtanen M, Schlienger R, Cousin M, Chipimo M, Sullivan FM. Safety of artemether-lumefantrine in pregnant women with malaria: results of a prospective cohort study in Zambia. Malar J. 2010 Sep 1;9:249. doi: 10.1186/1475-2875-9-249. |
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| WHO. Recommendations on intermittent screening and treatment in pregnancy and the safety of ACTs in the first trimester. | View source |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D050497 | Stillbirth |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided