Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate
Study Details
Study Description
Brief Summary
The purpose of this study is to compare the efficacy and safety of two antimalarial drug regimes, namely amodiaquine versus amodiaquine-artesunate, in the treatment of children with uncomplicated malaria. Also, genetic host factors which might influence efficacy and/or safety will be examined.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Malaria remains a major cause of morbidity and mortality among children in sub-Saharan Africa. Current malaria control largely consists of rapid treatment of patients. Amodiaquine-artesunate and other combinatory treatment regimes including amodiaquine are now being introduced as first-line antimalarial drugs in several African countries. However, data on the efficacy and safety of amodiaquine and amodiaquine-artesunate are scarce. In addition, there is evidence that common genetic host factors, e.g. sickle cell trait, may influence efficacy and safety of these drugs. To examine efficacy and safety of the named drugs as well as a potential influence of genetic host factors on these outcomes a randomized, double blind trial among 400 children with uncomplicated malaria is performed in northern Ghana.
Study Design
Outcome Measures
Primary Outcome Measures
- Parasitological and clinical cure rates by days 14 and 28 []
- Parasite and fever clearance times []
- Carrier rates of sexual parasite stages at days 7, 14 and 28 []
- Incidence rates of adverse events []
Secondary Outcome Measures
- Incidence rate of haematological and biochemical evidence of drug-induced toxicity []
- Primary endpoints in children with and without various genetic host factors []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and female outpatients aged 6 to 59 months
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Body weight >5 kg
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Uncomplicated Plasmodium falciparum malaria
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Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl
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Axillary temperature ≥37.5°C
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Ability to tolerate oral therapy
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Informed consent by the legal representative of the subject
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Residence in study area
Exclusion Criteria:
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Previous participation in this clinical trial
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Haemoglobin <5 mg/dl
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Mixed plasmodial infection
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Danger signs (unable to drink; repeated vomiting; recent history of convulsions;lethargic or unconscious state; unable to stand up or to sit) and signs of severe malaria as defined by WHO.
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Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection)
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Concomitant disease masking assessment of response
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History of allergy or intolerance against study medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University for Development Studies | Tamale | Northern Region | Ghana |
Sponsors and Collaborators
- Charite University, Berlin, Germany
- University for Development Studies, Tamale, Ghana
- Kintampo Health Research Centre, Ghana
Investigators
- Principal Investigator: Rowland N Otchwemah, PhD, University for Development Studies
- Principal Investigator: Frank P Mockenhaupt, MD, Malaria Unit, Institute of Tropical Medicine, Charite University, Berlin, Germany
- Principal Investigator: Seth Owusu-Agyei, PhD, Kintampo Health Research Centre, Ghana
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NP05-M4
- A50068