Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso

Study Overview
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Brief Summary
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The purpose of the study is to investigate the safety and efficacy profile of a new paediatric MB formulation combined with AQ or AS and compared to AS-AQ in young African children with uncomplicated falciparum malaria.

Official Title
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Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso: RCT in the Frame of the A8 Project of SFB 544

Conditions
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Malaria

Intervention / Treatment
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* Drug: Methylenblue-Amodiaquine (MB-AQ)
* Drug: Methylenblue-Artesunate (MB-AS)
* Drug: Artesunate-Amodiaquine (AS-AQ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 0.5-5 year (6-59 months) old children uncomplicated malaria caused by P. falciparum asexual parasites ≥ 2000/µ and ≤ 200000/µ axillary temperature ≥ 37.5 Celsius or a history of fever during last 24 hours Burkinabe nationality informed consent Exclusion Criteria: complicated or severe malaria any apparent significant disease anaemia (haematocrit < 21%) treated in the same trial before modern antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine

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

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: 1-Methylenblue-Amodiaquine<br> | Drug: Methylenblue-Amodiaquine (MB-AQ)<br>* For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ<br>|
| Active Comparator: 2-Methylenblue-Artesunate<br> | Drug: Methylenblue-Artesunate (MB-AS)<br>* 3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days<br>|
| Active Comparator: 3-Artesunate-Amodiaquine<br> | Drug: Artesunate-Amodiaquine (AS-AQ)<br>* For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of observed and self-reported non-serious adverse events over the 28 days observation period |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR) |  | 28 days | 
| Early treatment failure (ETF) rate |  | 28 days | 
| Late clinical failure (LCF) rate at D14 and D28 |  | 28 days | 
| Late parasitological failure (LPF) rate at D14 and D28 |  | 28 days | 
| Fever clearance time |  | 28 days | 
| Parasite clearance time |  | 28 days | 
| Change in haematocrit after 2,14 and 28 days compared to baseline |  | 28 days | 
| MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose |  | 28 days |