Effectiveness of Intermittent Preventive Treatment for Malaria in Children
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ClinicalTrials.gov Identifier: NCT00119132 |
Recruitment Status :
Completed
First Posted : July 13, 2005
Last Update Posted : January 12, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malaria | Drug: artesunate-amodiaquine Drug: sulphadoxine-pyrimethamine | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2602 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | June 2005 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | December 2006 |

- 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

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Ages Eligible for Study: | 3 Months to 59 Months (Child) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119132
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 |
Responsible Party: | Brian Greenwood, Professor, London School of Hygiene and Tropical Medicine |
ClinicalTrials.gov Identifier: | NCT00119132 |
Other Study ID Numbers: |
ITCR5098 |
First Posted: | July 13, 2005 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | January 2017 |
intermittent preventive treatment effectiveness malaria |
Malaria Protozoan Infections Parasitic Diseases Artesunate Pyrimethamine Sulfadoxine Fanasil, pyrimethamine drug combination Amodiaquine Antimalarials Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents Antineoplastic Agents Antiviral Agents Schistosomicides Antiplatyhelmintic Agents Anthelmintics Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |