Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy
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|ClinicalTrials.gov Identifier: NCT00495508|
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : May 13, 2010
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Quinine Drug: artemether / lumefantrine||Phase 4|
Hide Detailed Description
Efficacy and Safety of Quinine vs Artemether/Lumefantrine in uncomplicated malaria during pregnancy, Mbarara, Uganda (2006/2007).
Investigational - Phase IV
Investigational Product and route:
- Quinine hydrochloride, oral route.
- Coartem® (Novartis Pharma AG, Basel, Switzerland), oral route.
Lead Investigator and Study Centre Primary objective - To establish that, in pregnant women with uncomplicated Plasmodium falciparum malaria, the PCR-adjusted efficacy of Artemether/Lumefantrine is not inferior to oral Quinine.
- To define the pharmacokinetics of the combination artemether-lumefantrine (AL) in the treatment of uncomplicated P. falciparum infections in the last two trimesters of pregnancy.
- To collect baseline data on maternal, obstetric and infant outcomes.
- To estimate the incidence of malaria infection, both microscopic and sub-microscopic (by PCR) during pregnancy.
- women attending Mbarara National Referral Hospital (MNRH) ante-natal clinic (ANC).
- Women with a positive blood smear during follow-up will be invited to participate in a non-inferiority, open, randomised, non- inferiority trial comparing the efficacy and tolerance of Coartem® (Artemether-Lumefantrine) for the treatment of uncomplicated malaria during second and third trimester pregnancy to oral Quinine hydrochloride. PCR-corrected adequate clinical and parasitological response (ACPR) on day 42 is considered as the primary efficacy criterion.
- Women with uncomplicated malaria from the efficacy study, will be followed to obtain an efficacy endpoint at 42 days OR at delivery, whichever timepoint is the last.
- Newborns will be followed monthly up to the age of 1 year.
Inclusion Criteria (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
Exclusion Criteria (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.
Study drugs and Administration
- Group 1 (Active Control): Quinine hydrochloride (10 mg/Kg/8h for 7 days) administered orally.
- Group 2 (Test): Coartem®, fixed Artemether-Lumefantrine (20/120 mg) GMP manufactured by Novartis Pharma AG (Basel, Switzerland), 4 tablets twice a day for 3 days with 200 ml of milk tea at each dose .
- Primary efficacy endpoint: PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42.
- Secondary efficacy endpoints:
- PCR-corrected(ACPR)at delivery
- Pharmacokinetic parameters
- Symptom clearance Time
- Proportion of patients who have fever cleared at Day 1, 2 and 3
- Safety endpoints:
- Incidence of any adverse events
- Pregnancy outcome
- Infant development during the first year of life
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
- PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery. [ Time Frame: 3 years ]
- Pharmacokinetic parameters [ Time Frame: 3.5 years ]
- Incidence of adverse events [ Time Frame: 3 years ]
- Pregnancy outcome [ Time Frame: 3.5 years ]
- Infant development during the first year of life [ Time Frame: 3 years ]
- Histopathological findings in the placenta [ Time Frame: 4 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495508
|Mbarara, Mbarara District, Uganda|
|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|