Quinine vs. Artemether/Lumefantrine in Uncomplicated Malaria During Pregnancy

This study has been completed.
Sponsor:
Collaborators:
Medecins Sans Frontieres
University of Cape Town
Sholklo Malaria Research Unit
Information provided by:
Epicentre
ClinicalTrials.gov Identifier:
NCT00495508
First received: July 2, 2007
Last updated: May 12, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Malaria
Drug: Quinine
Drug: artemether / lumefantrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Epicentre:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495508

Locations
Uganda
Epicentre
Mbarara, Mbarara District, Uganda
Sponsors and Collaborators
Epicentre
Medecins Sans Frontieres
University of Cape Town
Sholklo Malaria Research Unit
Investigators
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
  More Information

No publications provided by Epicentre

Additional 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
Study First Received: July 2, 2007
Last Updated: May 12, 2010
Health Authority: France: Institutional Ethical Committee

Keywords provided by Epicentre:
Quinine
Artemether
Lumefantrine
malaria
Uganda
Artemisinin- based combination therapy
pregnancy
Malaria In Pregnancy

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Quinine
Artemether
Artemisinins
Lumefantrine
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on August 26, 2014