Trial of the Effectiveness of AQ/AS, SP/AQ and SP/CQ for Uncomplicated Malaria in Gambian Children

Study Overview
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Brief Summary
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The purpose of this trial is to compare the effectiveness of three combination treatments for uncomplicated malaria when given in operational settings, without supervision of doses other than the first dose.

Detailed Description
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Children aged 0.5-10 years presenting at health centres with fever or history of fever and other symptoms suggestive of malaria will be screened; children found to have uncomplicated Plasmodium falciparum malaria will be randomized to receive treatment with AS/AQ, SP/AQ or SP/CQ. A drug dispenser will supervise the first dose of medication and subsequent doses will be given to the child's parent to be administered at home, unsupervised by the study team. Patients will be visited at home three days later. Unused medication will be counted and the mother will be asked about the number of doses the child received and any side effects. Children will be seen again 2 and 4 weeks after treatment to collect finger prick samples for packed cell volume (PCV) and malaria microscopy. The primary endpoint is clinical failure by day 28. Analysis will be by intention to treat.

Official Title
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Randomized Trial of the Effectiveness of Amodiaquine-Artesunate, Amodiaquine-Sulfadoxine-Pyrimethamine, and Chloroquine-Sulfadoxine-Pyrimethamine, for Treatment of Uncomplicated Malaria in Gambian Children

Conditions
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Malaria

Intervention / Treatment
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* Drug: Amodiaquine plus artesunate (AQ/AS)
* Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)
* Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presentation at health centre with febrile illness Monoinfection with P. falciparum Parasitaemia >=500/microlitre Fever or history of fever Exclusion Criteria: Signs of severe or complicated malaria (persistent vomiting with or without dehydration, history of convulsion during the present illness, inability to sit or stand, parasitaemia >200,000/ul) Severe malnutrition Clinically evident concomitant disease PCV <20% History of allergy to the study medications Residence outside the study area and hence difficult to follow up

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Amodiaquine plus artesunate (AQ/AS)|nan|
|Drug: Sulfadoxine-pyrimethamine plus chloroquine (SP/CQ)|nan|
|Drug: Sulfadoxine-pyrimethamine plus amodiaquine (SP/AQ)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical failure by day 28 |  |  | 
| Incidence of adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance with treatment regimen |  |  | 
| Parasitological failure by day 28 |  |  | 
| Clinical failure by day 14 |  |  | 
| Parasitological failure rate by day 14 |  |  | 
| Mean PCV on day 28 |  |  | 
| Gametocyte carriage rates |  |  | 
| Transmissibility after treatment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malaria treatment, artemisinin based combination therapy, Plasmodium falciparum, pragmatic trial, effectiveness