drugset / Trial / NCT03208179
Improving PRegnancy Outcomes With Intermittent preVEntive Treatment in Africa
Phase 3
Completed
4680 enrolled
Liverpool School of Tropical Medicine
Centers for Disease Control and Prevention · collabFoundation for Innovative New Diagnostics, Switzerland · collabKamuzu University of Health Sciences · collabKenya Medical Research Institute · collabKilimanjaro Christian Medical Centre, Tanzania · collabLondon School of Hygiene and Tropical Medicine · collabMalawi-Liverpool-Wellcome Trust Clinical Research Programme · collabNational Institute for Medical Research, Tanzania · collabTampere University · collabUniversity College, London · collabUniversity of Bergen · collabUniversity of Copenhagen · collabUniversity of Massachusetts, Worcester · collabUniversity of Melbourne · collabUniversity of Toronto · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study evaluates the efficacy and safety of monthly intermittent preventive treatment using dihydroartemisinin piperaquine (DP) alone or in combination with azithromycin (AZ) compared to sulphadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women in the second and third trimester.
Timeline
- Start
- 2018-03-29
- Primary completion
- 2020-03-15
- Completion
- 2020-03-15
Outcome
Missed primary endpoint
paper the primary composite endpoint of adverse pregnancy outcomes was reported more frequently in the dihydroartemisinin-piperaquine group PMID 36913959 ↗
paper risk ratio 1·20, 95% CI 1·06-1·36; p=0·0040 PMID 36913959 ↗
paper the addition of a single course of azithromycin did not enhance the effect of monthly IPTp with dihydroartemisinin-piperaquine PMID 36913959 ↗
Publications
- Gore-Langton GR, Madanitsa M, Barsosio HC, Minja DTR, Mosha J, Kavishe RA, Mtove G, Gesase S, Msemo OA, Kariuki S, Otieno K, Phiri KS, Lusingu JPA, Mukerebe C, Manjurano A, Ikigo P, Saidi Q, Onyango ED, Schmiegelow C, Dodd J, Hill J, Hansson H, Alifrangis M, Gutman J, Hunter PJ, Klein N, Ashorn U, Khalil A, Cairns M, Ter Kuile FO, Chico RM. Prevalence and risk factors of curable sexually transmitted and reproductive tract infections and malaria co-infection among pregnant women at antenatal care booking in Kenya, Malawi and Tanzania: a cross-sectional study of randomised controlled trial data. BMJ Public Health. 2024 Sep 18;2(2):e000501. doi: 10.1136/bmjph-2023-000501. eCollection 2024 Dec.
- Madanitsa M, Barsosio HC, Minja DTR, Mtove G, Kavishe RA, Dodd J, Saidi Q, Onyango ED, Otieno K, Wang D, Ashorn U, Hill J, Mukerebe C, Gesase S, Msemo OA, Mwapasa V, Phiri KS, Maleta K, Klein N, Magnussen P, Lusingu JPA, Kariuki S, Mosha JF, Alifrangis M, Hansson H, Schmiegelow C, Gutman JR, Chico RM, Ter Kuile FO. Effect of monthly intermittent preventive treatment with dihydroartemisinin-piperaquine with and without azithromycin versus monthly sulfadoxine-pyrimethamine on adverse pregnancy outcomes in Africa: a double-blind randomised, partly placebo-controlled trial. Lancet. 2023 Mar 25;401(10381):1020-1036. doi: 10.1016/S0140-6736(22)02535-1. Epub 2023 Mar 10.
- Mtove G, Abdul O, Kullberg F, Gesase S, Scheike T, Andersen FM, Madanitsa M, Ter Kuile FO, Alifrangis M, Lusingu JPA, Minja DTR, Schmiegelow C. Weight change during the first week of life and a new method for retrospective prediction of birthweight among exclusively breastfed newborns. Acta Obstet Gynecol Scand. 2022 Mar;101(3):293-302. doi: 10.1111/aogs.14323. Epub 2022 Feb 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azithromycin | Small molecule | 500 mg | — |
| Subject | Dihydroartemisinin-piperaquine | Unknown | 40 mg | — |
| Subject | Dihydroartemisinin-piperaquine | Unknown | 320 mg | — |
| Comparator | sulphadoxine-pyrimethamine | Small molecule | 75 mg | — |
| Comparator | sulphadoxine-pyrimethamine | Small molecule | 1500 mg | — |