Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance

This study has been completed.
Sponsor:
Collaborator:
DBL -Institute for Health Research and Development
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00140517
First received: August 31, 2005
Last updated: March 30, 2009
Last verified: March 2009
  Purpose

Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy.

This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks.

The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.


Condition Intervention
Malaria in Pregnancy
Birth Weight
Anaemia
Drug: sulphadoxine-pyrimethamine
Drug: chloroquine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • See detailed description

Secondary Outcome Measures:
  • see detailed description

Estimated Enrollment: 700
Study Start Date: October 2002
Study Completion Date: March 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primi or secundigravidae - seen between 12th and 24th weeks of gestation

    • with a non 'at risk pregnancy' (multiple pregnancy, obstetric misproportions, previous caesarean, high blood pressure, diabetes, clinical signs of AIDS.
    • staying in a neighbouring district or village
    • ability to come for follow-up and delivery.

Exclusion Criteria:

  • • At risk pregnancy

    • Severe systemic disease
    • Wish to withdraw from participation.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00140517

Locations
Burkina Faso
Centre Medicale Paul VI
Ouagadougou, Burkina Faso, 01-2099
Sponsors and Collaborators
Gates Malaria Partnership
DBL -Institute for Health Research and Development
Investigators
Principal Investigator: Sheick O Coulibaly, MD Laboratoire National de Sante Publique
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00140517     History of Changes
Other Study ID Numbers: HSR/DD/677-01/DG-CM/624-02
Study First Received: August 31, 2005
Last Updated: March 30, 2009
Health Authority: Burkina Faso: Ministry of Health

Keywords provided by Gates Malaria Partnership:
Plasmodium falciparum
malaria
pregnancy
resistance

Additional relevant MeSH terms:
Malaria
Birth Weight
Protozoan Infections
Parasitic Diseases
Body Weight
Signs and Symptoms
Fanasil, pyrimethamine drug combination
Sulfadoxine
Pyrimethamine
Antimalarials
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014