We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00495508
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : June 3, 2022
Medecins Sans Frontieres, Netherlands
University of Cape Town
Shoklo Malaria Research Unit
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: Quinine Drug: artemether / lumefantrine Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Pregnancy

Arm Intervention/treatment
Active Comparator: Quinine Drug: Quinine
Active Comparator: Arthemeter lumefantrine Drug: artemether / lumefantrine

Primary Outcome Measures :
  1. PCR-corrected adequate clinical and parasitological response (ACPR) on Day 42 or at delivery. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 3.5 years ]
  2. Incidence of adverse events [ Time Frame: 3 years ]
  3. Pregnancy outcome [ Time Frame: 3.5 years ]
  4. Infant development during the first year of life [ Time Frame: 3 years ]
  5. Histopathological findings in the placenta [ Time Frame: 4 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

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

Layout table for location information
Mbarara, Mbarara District, Uganda
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
University of Cape Town
Shoklo Malaria Research Unit
Layout table for investigator information
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT00495508    
Other Study ID Numbers: Mba/06/MIP
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: June 3, 2022
Last Verified: August 2019
Keywords provided by Epicentre:
Artemisinin- based combination therapy
Malaria In Pregnancy
Additional relevant MeSH terms:
Layout table for MeSH terms
Protozoan Infections
Parasitic Diseases
Vector Borne Diseases
Artemether, Lumefantrine Drug Combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents