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Sponsors and Collaborators: |
Gates Malaria Partnership Ministry of Health, Ghana |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00146783 |
In areas of stable transmission, pregnant women, especially during the first and second pregnancies, have an increased susceptibility to Plasmodium falciparum malaria, malaria-related anaemia and an increased risk of having low birthweight babies. Intermittent Preventive Treatment in pregnancy(IPTp) with sulphadoxine-pyrimethamine has been shown to be effective in reducing the effects of malaria in pregnancy. This has mainly been in areas of perennial transmission and there is a need to study this effect in intense seasonal transmission settings. The emergence and spread of resistance to SP is likely to undermine its useful lifespan and it is important that other antimalarials that are safe and effective are identified for use in IPTp. The options are however limited. Amodiaquine has been shown to be effective in treatment of clinical cases of malaria, even in areas where chloroquine resistance is prevalent, and its combination with SP has been associated with favourable results. Both are affordable. However, there is limited data on their use in pregnancy. This study aims to assess the efficacy of SP in an area of intense seasonal transmission, and evaluate the safety and efficacy of amodiaquine and a combination of sulphadoxine-pyrimethamine and amodiaquine as possible alternatives to SP for use as IPTp.
Condition | Intervention | Phase |
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Malaria |
Drug: Sulphadoxine-pyrimethamine Drug: Sulphadoxine-pyrimethamine, amodiaquine |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Sulphadoxine-Pyrimethamine and Amodiaquine Alone or in Combination as Intermittent Preventive Treatment in Pregnancy in the Kassena-Nankana District of Ghana: a Randomized Controlled Trial |
Enrollment: | 3642 |
Study Start Date: | June 2004 |
Study Completion Date: | February 2007 |
Ages Eligible for Study: | 15 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ghana, Upper East Region | |
Navrongo District Hosptial | |
Navrongo, Upper East Region, Ghana |
Principal Investigator: | Christine Clerk, MBChB, MSc | London School of Hygiene and Tropical Medicine |
Principal Investigator: | Daniel Chandramohan, MBBS, PhD | London School of Hygiene and Tropical Medicine |
Principal Investigator: | Brian Greenwood, FRCP, FRS | London School of Hygiene and Tropical Medicine |
Study ID Numbers: | ITCR5096 |
Study First Received: | September 5, 2005 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00146783 |
Health Authority: | Ghana: Ministry of Health |
intermittent preventive treatment malaria pregnancy efficacy safety |
Folic Acid Pyrimethamine Protozoan Infections Amodiaquine |
Sulfadoxine-pyrimethamine Parasitic Diseases Malaria Sulfadoxine |
Anti-Infective Agents Antimalarials Antiparasitic Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis |
Therapeutic Uses Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents Folic Acid Antagonists Pharmacologic Actions |