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| Sponsors and Collaborators: |
Gates Malaria Partnership Ghana:INDEPTH Network |
|---|---|
| Information provided by: | Gates Malaria Partnership |
| ClinicalTrials.gov Identifier: | NCT00119132 |
Purpose
Intermittent preventive treatment for malaria in children (IPTc) is a promising new approach to malaria control. Preliminary studies of IPTc in Senegal and Mali indicate that this approach can be very effective. Although the results of these studies suggest that IPTc with sulphadoxine-pyrimethamine (SP) plus artesunate (AS) or SP alone is an efficacious and safe intervention for reducing the burden of malaria and anaemia in children in high transmission areas with short transmission periods, there is no data from areas with long transmission periods. This study aims to evaluate the effectiveness of IPTc in reducing anaemia and malaria in an area with up to 6 months of transmission in Ghana. Two thousand two hundred forty children aged 3-59 months will be randomly allocated to four groups (560 per arm) to receive amodiaquine plus artesunate (AQ+AS), given at two different intervals (monthly or bimonthly), SP or placebo. The children will also be followed to determine if there is any rebound in the incidence of severe malaria and anaemia in the year following IPTc.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria |
Drug: artesunate-amodiaquine Drug: sulphadoxine-pyrimethamine |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Study Of Impact Of Intermittent Preventive Treatment In Children With Amodiaquine Plus Artesunate Versus Sulphadoxine-Pyrimethamine On Hemoglobin Levels And Malaria Morbidity In Hohoe District Of Ghana |
| Enrollment: | 2602 |
| Study Start Date: | June 2005 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Months to 59 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Ghana, Volta region | |
| Ministry of Health, Hohoe district hospital | |
| Hohoe, Volta region, Ghana | |
| Principal Investigator: | Margaret Kweku, MBChB, MPH | 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 |
More Information
| Responsible Party: | London School of Hygiene & Tropical Medicine ( Daniel Chandramohan ) |
| Study ID Numbers: | ITCR5098 |
| Study First Received: | July 4, 2005 |
| Last Updated: | January 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00119132 History of Changes |
| Health Authority: | Ghana: Ministry of Health |
|
intermittent preventive treatment effectiveness malaria |
|
Folic Acid Artesunate Pyrimethamine Antimalarials Protozoan Infections Amodiaquine |
Sulfadoxine-pyrimethamine Anti-Infective Agents, Urinary Parasitic Diseases Malaria Folic Acid Antagonists Sulfadoxine |
|
Pyrimethamine Artesunate Protozoan Infections Anti-Infective Agents Amodiaquine Sulfadoxine-pyrimethamine Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Coccidiosis Anti-Infective Agents, Urinary Enzyme Inhibitors |
Malaria Renal Agents Folic Acid Antagonists Sulfadoxine Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Parasitic Diseases Amebicides |
