Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Study Overview
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Brief Summary
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Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Phase: Phase II. Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen. Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso. Sample size: 180 patients (90 per study arm).

Official Title
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Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children

Conditions
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Uncomplicated Falciparum Malaria

Intervention / Treatment
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* Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 6-59 months old children (male and female) Weight ≥ 6kg Uncomplicated malaria caused by P. falciparum Asexual parasites ≥ 2 000/µl and ≤ 200 000/µl Axillary temperature ≥ 37.5°C or a history of fever during last 24 hours Burkinabe nationality Permanent residence in the study area with no intention of leaving during the surveillance period Informed consent Exclusion Criteria: Severe malaria (WHO 2000) Vomiting (3 or more within 24 hours before the visit) Any apparent significant disease, including severe malnutrition A history of a previous, significant adverse reaction to either of the study drugs Anaemia (haemoglobin < 7 g/dl) Treated in the same trial before All modern antimalarial treatment prior to inclusion (last seven days) Simultaneous participation in another investigational study Treatment with other investigational drugs

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: artesunate, amodiaquine methylene blue<br>two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Intervention: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) control: artesunate (AS) - amodiaquine (AQ) | Drug: artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)<br>* The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.<br>|
| No Intervention: artesunate amodiaquine<br>The control group will receive once daily a fixed dose AS-AQ over three days. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P. falciparum gametocyte prevalence | P. falciparum gametocyte prevalence on day 14 of follow-up (PCR determination) | day 14 of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P. falciparum gametocyte prevalence and density | P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (PCR determination) P. falciparum gametocyte prevalence and density on day 1, 2, 3, 7, and 28 of follow-up (microscopic determination) | day 1, 2, 3, 7, and 28 of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children