|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Gates Malaria Partnership |
|---|---|
| Collaborator: |
National Institute for Medical Research, Tanzania |
| Information provided by: | Gates Malaria Partnership |
| ClinicalTrials.gov Identifier: | NCT00146731 |
Purpose
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 |
|---|---|---|
|
Malaria |
Drug: SP Drug: SP + amodiaquine Drug: AQ + artesunate Drug: chlorproguanil-dapsone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treating Malaria During Pregnancy: A Randomized Trial of Potential Options for Treatment in an Area of High Drug Resistance in Tanzania |
| Enrollment: | 310 |
| Study Start Date: | January 2004 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| 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/uL in an asymptomatic woman
or any of the following symptoms within 2 days prior to consultation:
and (in both cases) the following:
Exclusion Criteria:
Contacts and Locations| Tanzania | |
| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00146731 History of Changes |
| Other Study ID Numbers: | ITCRVG04 |
| Study First Received: | September 5, 2005 |
| Last Updated: | February 17, 2010 |
| Health Authority: | Tanzania: Ministry of Health |
|
malaria pregnancy treatment Africa Tanzania |
|
Malaria Protozoan Infections Parasitic Diseases Amodiaquine Antimalarials Dapsone Artesunate Chlorproguanil Proguanil Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Anti-Bacterial Agents Amebicides Antimetabolites |