Efficacy of Intermittent Screening and Treatment or Intermittent Preventive Treatment (IPT) With Dihydroartemisinin-Piperaquine, Versus IPT With Sulfadoxine-Pyrimethamine for the Control of Malaria in Pregnancy in Kenya
Summary
Malaria in pregnancy (MiP) due to Plasmodium falciparum infection is a major cause of maternal morbidity and poor birth outcomes. Intermittent preventive treatment in pregnancy (IPTp) with Sulfadoxine pyrimethamine (SP), the administration of SP at predefined intervals in the second and third trimesters of pregnancy irrespective of the presence of malaria parasitemia, is currently recommended for HIV-negative women in all areas with stable moderate to high transmission of malaria. Due to increasing resistance to SP, it is no longer used as a treatment for symptomatic malaria, and the efficacy of IPTp-SP seems to be decreased. This study aims to look at a new drug, Dihydroartemisinin-Piperaquine (DP) for IPTp, as well as to explore the strategy of intermittent screening and treatment in pregnancy (ISTp) with DP. This strategy uses increased screening at time of focused antenatal care (FANC) with treatment of women who screen positive. The hypothesis is that the efficacy of both IPTp-DP and ISTp-DP will be associated with a reduction in malaria infection at delivery among HIV(-) women when compared to IPTp-SP, in an area with decreasing malaria transmission and high levels of SP resistance in Kenya.
Timeline
- Start
- 2012-08
- Primary completion
- 2014-10
- Completion
- 2015-12
Outcome
Mixed primary results
paper Prevalence of malaria infection at delivery was lower in the intermittent preventive treatment with dihydroartemisinin-piperaquine group than in the intermittent preventive treatment with sulfadoxine-pyrimethamine group PMID 26429700 ↗
paper 15 [3%] of 457 women vs 47 [10%] of 459 women; relative risk 0·32, 95% CI 0·18-0·56; p<0·0001 PMID 26429700 ↗
paper but not in the intermittent screening and treatment with dihydroartemisinin-piperaquine group (57 [13%] of 452 women; 1·23, 0·86-1·77; p=0·26). PMID 26429700 ↗
Publications
- Chotsiri P, Gutman JR, Ahmed R, Poespoprodjo JR, Syafruddin D, Khairallah C, Asih PBS, L'lanziva A, Otieno K, Kariuki S, Ouma P, Were V, Katana A, Price RN, Desai M, Ter Kuile FO, Tarning J. Piperaquine Pharmacokinetics during Intermittent Preventive Treatment for Malaria in Pregnancy. Antimicrob Agents Chemother. 2021 Feb 17;65(3):e01150-20. doi: 10.1128/AAC.01150-20. Print 2021 Feb 17.
- Desai M, Gutman J, L'lanziva A, Otieno K, Juma E, Kariuki S, Ouma P, Were V, Laserson K, Katana A, Williamson J, ter Kuile FO. Intermittent screening and treatment or intermittent preventive treatment with dihydroartemisinin-piperaquine versus intermittent preventive treatment with sulfadoxine-pyrimethamine for the control of malaria during pregnancy in western Kenya: an open-label, three-group, randomised controlled superiority trial. Lancet. 2015 Dec 19;386(10012):2507-19. doi: 10.1016/S0140-6736(15)00310-4. Epub 2015 Sep 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ARTENIMOL | Small molecule | 80 mg | Oral |
| Subject | ARTENIMOL | Small molecule | 120 mg | Oral |
| Subject | ARTENIMOL | Small molecule | 160 mg | Oral |
| Subject | piperaquine | Small molecule | 640 mg | Oral |
| Subject | piperaquine | Small molecule | 960 mg | Oral |
| Subject | piperaquine | Small molecule | 1280 mg | Oral |
| Comparator | pyrimethamine | Small molecule | 75 mg | — |
| Comparator | sulfadoxine | Small molecule | 1500 mg | — |