Effectiveness of Intermittent Preventive Treatment for Malaria in Children
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| 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 |
- Mean Hb at the end of the high transmission season.
- Incidence of moderate (Hb<8.0g/dl>5.0g/dl) and severe anaemia (Hb<5.0g/dl) during the period of the intervention
- Incidence of severe and clinical malaria during the period of the intervention
- Prevalence of anaemia at the post intervention survey
- Prevalence of parasitaemia and gametocytemia at the post intervention survey
- Prevalence of molecular markers of resistance to SP among children who have malaria at the post intervention survey
| 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:
- Children between the ages of 3-59 months resident in the selected communities
- Children likely to be available for follow-up for 18 months
- Consent by parent/guardian of child
Exclusion Criteria:
- Chronic illness
- History of hypersensitivity to any of the study drugs
Contacts and Locations| Ghana | |
| 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
Additional Information:
No publications provided by Gates Malaria Partnership
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daniel Chandramohan, London School of Hygiene & Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT00119132 History of Changes |
| Other Study ID Numbers: | ITCR5098 |
| Study First Received: | July 4, 2005 |
| Last Updated: | January 14, 2009 |
| Health Authority: | Ghana: Ministry of Health |
Keywords provided by Gates Malaria Partnership:
|
intermittent preventive treatment effectiveness malaria |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases Amodiaquine Pyrimethamine Sulfadoxine Artesunate Sulfadoxine-pyrimethamine Antimalarials Antiprotozoal Agents |
Antiparasitic Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents Amebicides |
ClinicalTrials.gov processed this record on June 17, 2013