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Sponsors and Collaborators: |
Gates Malaria Partnership London School of Hygiene and Tropical Medicine Ministry of Health, Ghana |
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Information provided by: | Gates Malaria Partnership |
ClinicalTrials.gov Identifier: | NCT00131703 |
Malaria in pregnancy is potentially fatal to both the mother and the foetus particularly in the primigravidae. Implementation of appropriate control and preventive measures is challenged by the fact that malaria infection in pregnancy is often asymptomatic and parasitized red blood cells sequestrated in the placental microcirculation may not be detectable in the peripheral blood. In addition, the widespread prevalence of parasites resistant to chloroquine and sulphadoxine-pyrimethamine (SP) and, the safety concerns about newer antimalarials, poverty and inadequate supply have made antimalarial treatment options available to pregnant women very limited. These have necessitated an urgent search for alternative safe and efficacious treatment options for pregnant women. The objective of this study is to assess the efficacy, safety and tolerability of four antimalarial treatment options in rural Ghana within a programme setting.
Condition | Intervention | Phase |
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Malaria Pregnancy |
Drug: Amodiaquine Drug: Sulphadoxine-pyrimethamine Drug: Chloroquine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised Double Blind Clinical Trial of Amodiaquine (AQ) and Sulphadoxine-Pyrimethamine (SP) Used Singly and in Combination (AQ+SP) Compared With Chloroquine (CQ) in the Treatment of Falciparum Malaria Infection in Pregnancy |
Estimated Enrollment: | 900 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | March 2005 |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Harry K Tagbor, MD | London School of Hygiene and Tropical Medicine |
Study ID Numbers: | ITCR5092 |
Study First Received: | August 18, 2005 |
Last Updated: | December 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00131703 |
Health Authority: | Ghana: Ministry of Health |
Screening Treatment Amodiaquine Sulphadoxine-pyrimethamine Malaria in pregnancy |
Folic Acid Pyrimethamine Protozoan Infections Amodiaquine Sulfadoxine-pyrimethamine Chloroquine diphosphate |
Chloroquine Parasitic Diseases Malaria Sulfadoxine Malaria, Falciparum |
Anti-Inflammatory Agents Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Renal Agents Antimalarials Antiparasitic Agents Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Amebicides |
Antinematodal Agents Coccidiosis Filaricides Anthelmintics Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Pharmacologic Actions Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |