drugset / Trial / NCT00495508
Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy
Phase 4
Completed
300 enrolled
Epicentre
Medecins Sans Frontieres, Netherlands · collabShoklo Malaria Research Unit · collabUniversity of Cape Town · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. The PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion. Newborns will be followed for growth and development indicators.
Timeline
- Start
- 2006-10
- Primary completion
- 2009-06
- Completion
- 2009-06
Publications
- De Beaudrap P, Turyakira E, Nabasumba C, Tumwebaze B, Piola P, Boum Ii Y, McGready R. Timing of malaria in pregnancy and impact on infant growth and morbidity: a cohort study in Uganda. Malar J. 2016 Feb 16;15:92. doi: 10.1186/s12936-016-1135-7.
- De Beaudrap P, Turyakira E, White LJ, Nabasumba C, Tumwebaze B, Muehlenbachs A, Guerin PJ, Boum Y, McGready R, Piola P. Impact of malaria during pregnancy on pregnancy outcomes in a Ugandan prospective cohort with intensive malaria screening and prompt treatment. Malar J. 2013 Apr 24;12:139. doi: 10.1186/1475-2875-12-139.
- Muehlenbachs A, Nabasumba C, McGready R, Turyakira E, Tumwebaze B, Dhorda M, Nyehangane D, Nalusaji A, Nosten F, Guerin PJ, Piola P. Artemether-lumefantrine to treat malaria in pregnancy is associated with reduced placental haemozoin deposition compared to quinine in a randomized controlled trial. Malar J. 2012 May 3;11:150. doi: 10.1186/1475-2875-11-150.
- Piola P, Nabasumba C, Turyakira E, Dhorda M, Lindegardh N, Nyehangane D, Snounou G, Ashley EA, McGready R, Nosten F, Guerin PJ. Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. Lancet Infect Dis. 2010 Nov;10(11):762-9. doi: 10.1016/S1473-3099(10)70202-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Artemether | Small molecule | 20 mg | Oral |
| Comparator | Quinine | Small molecule | 10 mg/kg | Oral |
| Comparator | lumefantrine | Small molecule | 120 mg | Oral |