Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy
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)
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedJune 3, 2022
August 1, 2019
2.7 years
July 2, 2007
May 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery.
3 years
Secondary Outcomes (5)
Pharmacokinetic parameters
3.5 years
Incidence of adverse events
3 years
Pregnancy outcome
3.5 years
Infant development during the first year of life
3 years
Histopathological findings in the placenta
4 years
Study Arms (2)
Quinine
ACTIVE COMPARATORArthemeter lumefantrine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Cohort Study:
- Weeks of pregnancy between 13 and 22 weeks
- Resident in Mbarara Municipality (radius of 15km from MNRH)
- Cohort study signed informed consent form
- Efficacy Study:
- Pregnant woman
- Malaria infection, detected by microscopy, with P. falciparum (mixed or mono-infection)
- Age of gestation: 13 weeks and beyond
- Efficacy study signed informed consent form
You may not qualify if:
- Efficacy Study:
- P. falciparum parasitaemia above 250,000 parasites/μl
- Severe anaemia
- Signs or symptoms of severe/complicated malaria requiring parenteral treatment (WHO 2000)
- Known allergy to artemisinin derivatives, lumefantrine or quinine;
- Previous participation in the efficacy study
- Inability to attend the efficacy study follow-up schedule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epicentrelead
- Medecins Sans Frontieres, Netherlandscollaborator
- University of Cape Towncollaborator
- Shoklo Malaria Research Unitcollaborator
Study Sites (1)
Epicentre
Mbarara, Mbarara District, Uganda
Related Publications (4)
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.
PMID: 26879849DERIVEDDe 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.
PMID: 23617626DERIVEDMuehlenbachs 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.
PMID: 22554092DERIVEDPiola 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.
PMID: 20932805DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrice Piola, MD, MPH
Epicentre
- STUDY CHAIR
Philippe J Guerin, MD, MPH, PhD
Epicentre
- STUDY CHAIR
Elizabeth Ashley, MB BS
Epicentre
- STUDY CHAIR
Rose McGready, MD, PhD
Shoklo Malaria Research Unit (SMRU)
- STUDY CHAIR
François Nosten, MD, PhD
SMRU
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 3, 2007
Study Start
October 1, 2006
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
June 3, 2022
Record last verified: 2019-08