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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
Medecins Sans Frontieres, Netherlands
University of Cape Town
Shoklo Malaria Research Unit
Information provided by:

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 Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated 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)
Study Start Date : October 2006
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria
U.S. FDA Resources

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

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Ages Eligible for Study:   Child, Adult, Senior
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

Mbarara, Mbarara District, Uganda
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
University of Cape Town
Shoklo Malaria Research Unit
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):
Responsible Party: Dr Patrice Piola, Epicentre
ClinicalTrials.gov Identifier: NCT00495508     History of Changes
Other Study ID Numbers: Mba/06/MIP
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: May 13, 2010
Last Verified: May 2010

Keywords provided by Epicentre:
Artemisinin- based combination therapy
Malaria In Pregnancy

Additional relevant MeSH terms:
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Sensory System Agents