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

NCT00140517 | Completed DMC

• 1 other identifier: HSR/DD/677-01/DG-CM/624-02
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria in Pregnancy; Birth Weight; Anaemia

Keywords

Plasmodium falciparum; malaria; pregnancy; resistance

Outcome Measures

Primary Outcomes (1)

• See detailed description

Secondary Outcomes (1)

• see detailed description

Interventions

sulphadoxine-pyrimethamine DRUG

chloroquine DRUG

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• At risk pregnancy
• Severe systemic disease
• Wish to withdraw from participation.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• DBL -Institute for Health Research and Development: collaborator

Study Sites (1)

Centre Medicale Paul VI

Ouagadougou, Ouagadougou, 01-2099, Burkina Faso

Location

Related Links

• DBL-Centre for Health Resaerch and Development

MeSH Terms

Conditions

Birth Weight; Anemia; Malaria, Falciparum; Malaria

Interventions

fanasil, pyrimethamine drug combination; Chloroquine

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sheick O Coulibaly, MD

  Laboratoire National de Sante Publique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2002
• Primary Completion: June 1, 2007
• Study Completion: March 1, 2008
• Last Updated: January 12, 2017

Record last verified: 2017-01

Locations

BU (1)