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Daily Co-trimoxazole Prophylaxis to Prevent Malaria in Pregnancy

NCT00711906 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2016-01-18

No results posted yet for this study

Summary

Malaria is a major contributor of disease burden in Sub-Saharan Africa, and pregnant women and children are the most vulnerable population. Malaria in pregnancy increases the risks of abortion, prematurity, maternal anaemia, low birth weight (LBW), perinatal, neonatal and infant mortality. For prevention and control of malaria in pregnancy, Intermittent Preventive Treatment (IPT), insecticide treated nets (ITNs) and case management for malaria and anemia are recommended.

HIV infection in pregnancy increases the risk of malaria, LBW, post-natal mortality and also of anaemia. In pregnant women, HIV infection decreases the efficacy of IPT with the medicine sulfadoxine-pyrimethamine (SP), which is the only treatment with proven efficacy and safety in IPT and is recommended by the World Health Organization (WHO). Unfortunately, there is a documented increase of resistance to SP, so cotrimoxazole (CTX) could be an alternative: many studies in Zambia and Uganda demonstrated that it reduces mortality and morbidity in HIV infected persons, and CTX prophylaxis significantly improves birth outcomes in immuno-suppressed HIV women. Unfortunately, there is not yet information on its effectiveness for preventing placental malaria infection, maternal anaemia and LBW. Thus in this study, we aim to establish the safety and efficacy of daily CTX in preventing malaria infection during pregnancy and its consequences, both in HIV infected and non-infected pregnant women. This information is urgently needed to assist to issue guidelines on IPT in pregnancy.

Conditions

  • Malaria in Pregnancy

Interventions

DRUG

Cotrimoxazole

Cotrimoxazole

DRUG

Sulfadoxine-pyrimethamine

Sulfadoxine-pyrimethamine

Sponsors & Collaborators

  • Tropical Diseases Research Centre, Zambia

    collaborator OTHER_GOV

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Christine Manyando, MD · Tropical Diseases Research Centre

  • Jean-Pierre Van geertruyden, MD PhD · Institute of Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2010-09-30

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00711906 on ClinicalTrials.gov