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Sponsors and Collaborators: |
Gates Malaria Partnership National Institute for Medical Research, Tanzania |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00146731 |
Pregnant women are vulnerable to malaria, with significant implications both for their health and for the pregnancy. Sulfadoxine-pyrimethamine (SP) is currently the first line drug for the treatment of malaria in pregnancy in Tanzania and surrounding countries, but resistance is emerging rapidly. Alternative drugs must be found, and new drugs and drug combinations are being recommended by many for deployment as first line treatment at the point that SP resistance forces a policy change. However, there are few data on the safety and efficacy of these combinations in pregnant women. This randomised trial aims to assess efficacy and safety, including birth outcome, in pregnant women with malaria in the second or third trimesters. A total of 900 pregnant women will be randomised either to standard treatment (SP) or to one of three potential drugs, or drug combinations recently recommended by a WHO expert panel. These will be SP-amodiaquine, chlorproguanil-dapsone (Lapdap), and amodiaquine-artesunate. Primary outcome will be treatment failure. Secondary outcomes will include 28 day slide clearance, maternal side effects, foetal viability and birth outcome.
Condition | Intervention | Phase |
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Malaria |
Drug: SP Drug: SP + amodiaquine Drug: AQ + artesunate Drug: chlorproguanil-dapsone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treating Malaria During Pregnancy: A Randomized Trial of Potential Options for Treatment in an Area of High Drug Resistance in Tanzania |
Estimated Enrollment: | 310 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | July 2006 |
Ages Eligible for Study: | 15 Years to 38 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A pregnant woman who has either a positive blood smear for P.falciparum with at least 1000 asexual parasites/μL in an asymptomatic woman
or any of the following symptoms within 2 days prior to consultation:
and/or any of the following signs:
and (in both cases) the following:
Exclusion Criteria:
Tanzania, Tanga | |
Muheza Designated District Hospital | |
Muheza, Tanga, Tanzania, PB |
Study Director: | Theonest K Mutabingwa, MD PhD | LSHTM/NIMR |
Principal Investigator: | Christopher JM Whitty, FRCP | LSHTM |
Principal Investigator: | Daniel Chandramohan, MD | LSHTM |
Study ID Numbers: | ITCRVG04 |
Study First Received: | September 5, 2005 |
Last Updated: | April 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00146731 |
Health Authority: | Tanzania: Ministry of Health |
malaria pregnancy treatment Africa Tanzania |
Folic Acid Artesunate Protozoan Infections Amodiaquine Chloroguanide |
Dapsone Parasitic Diseases Malaria Chlorproguanil |
Antimetabolites Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Amebicides Leprostatic Agents |