Efficacy and Safety of Amodiaquine and Amodiaquine-Artesunate

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double Blind Trial on the Efficacy and Safety of Amodiaquine-Artesunate and Amodiaquine Alone in the Treatment of Children With Uncomplicated Falciparum Malaria

Conditions
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Malaria

Intervention / Treatment
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* Drug: amodiaquine-artesunate versus amodiaquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients aged 6 to 59 months Body weight >5 kg Uncomplicated Plasmodium falciparum malaria Mono-infection with P. falciparum with an asexual parasite density between 2,000 to 200,000 parasites/μl Axillary temperature ≥37.5°C Ability to tolerate oral therapy Informed consent by the legal representative of the subject Residence in study area Exclusion Criteria: Previous participation in this clinical trial Haemoglobin <5 mg/dl Mixed plasmodial infection 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. Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) Concomitant disease masking assessment of response History of allergy or intolerance against study medications

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amodiaquine-artesunate versus amodiaquine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of haematological and biochemical evidence of drug-induced toxicity |  |  | 
| Primary endpoints in children with and without various genetic host factors |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria, amodiaquine, artesunate, safety, efficacy