NCT00495508

A Randomised, Open-label Non-inferiority Trial of Artemether-lumefantrine Versus Quinine for the Treatment of Uncomplicated Falciparum Malaria During Pregnancy, Mbarara, Uganda (2006-2007)

Completed Phase 4 Last updated 31 May 2022

What this trial tests

Phase 4 trial testing Quinine in Malaria in 300 participants. Completed in 1 June 2009.

Timeline

1 October 2006

Primary endpoint
1 June 2009

1 June 2009

Quick facts

Lead sponsor	Epicentre
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	300
Start date	1 October 2006
Primary completion	1 June 2009
Estimated completion	1 June 2009
Sites	1 location across Uganda

Drugs / interventions tested

• Quinine (QUININE) — full drug profile →
• artemether / lumefantrine

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

Epicentre — full company profile →

Who can join

Eligibility, female only, with Malaria. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery.
  Time frame: 3 years

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of malaria during pregnancy on pregnancy outcomes in a Ugandan prospective cohort with intensive malaria screening and prompt treatment.
   De Beaudrap P, Turyakira E, White LJ, Nabasumba C, et al · · 2013 · cited 105× · PMID 23617626 · DOI 10.1186/1475-2875-12-139
2. Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial.
   Piola P, Nabasumba C, Turyakira E, Dhorda M, et al · · 2010 · cited 83× · PMID 20932805 · DOI 10.1016/s1473-3099(10)70202-4
3. Population Pharmacokinetics of Lumefantrine in Pregnant and Nonpregnant Women With Uncomplicated Plasmodium falciparum Malaria in Uganda.
   Kloprogge F, Piola P, Dhorda M, Muwanga S, et al · · 2013 · cited 41× · PMID 24226803 · DOI 10.1038/psp.2013.59
4. Pharmacokinetic properties of artemether, dihydroartemisinin, lumefantrine, and quinine in pregnant women with uncomplicated plasmodium falciparum malaria in Uganda.
   Tarning J, Kloprogge F, Dhorda M, Jullien V, et al · · 2013 · cited 35× · PMID 23917320 · DOI 10.1128/aac.00683-13
5. Timing of malaria in pregnancy and impact on infant growth and morbidity: a cohort study in Uganda.
   De Beaudrap P, Turyakira E, Nabasumba C, Tumwebaze B, et al · · 2016 · cited 33× · PMID 26879849 · DOI 10.1186/s12936-016-1135-7
6. Population pharmacokinetics of Artemether and dihydroartemisinin in pregnant women with uncomplicated Plasmodium falciparum malaria in Uganda.
   Tarning J, Kloprogge F, Piola P, Dhorda M, et al · · 2012 · cited 32× · PMID 22913677 · DOI 10.1186/1475-2875-11-293
7. Artemether-lumefantrine to treat malaria in pregnancy is associated with reduced placental haemozoin deposition compared to quinine in a randomized controlled trial.
   Muehlenbachs A, Nabasumba C, McGready R, Turyakira E, et al · · 2012 · cited 21× · PMID 22554092 · DOI 10.1186/1475-2875-11-150
8. Population pharmacokinetics of quinine in pregnant women with uncomplicated Plasmodium falciparum malaria in Uganda.
   Kloprogge F, Jullien V, Piola P, Dhorda M, et al · · 2014 · cited 15× · PMID 24970740 · DOI 10.1093/jac/dku228