Malaria
Conditions
Keywords
Malaria, Africa, Methalyne-blue, Artesunate, Amodiaquine
Brief summary
The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) in treating malaria among children compared to the safety of an AS-AQ regimen. The secondary objective is to investigate the efficacy of MB-AS and MB-AQ.
Detailed description
Objectives: The primary objective of this trial is to study the safety of the combination methylene blue (MB)-artesunate (AS) and MB-amodiaquine (AQ) given over three days in 6-10 year old children with uncomplicated falciparum malaria in a malaria endemic area compared to the safety of a three days AS-AQ regimen. Secondary objectives are to investigate the efficacy of MB-AS and MB-AQ. Population: Children aged 6-10 years with uncomplicated malaria from Nouna town. Sample size: N= 180 (n=60 for each group). Treatment: The participants in the MB-AS group will receive orally twice daily 9mg/kg MB combined with once daily 4mg/kg AS over 3 days. The participants in the MB-AQ group will receive orally twice daily 9mg/kg MB combined with once daily 10mg/kg AQ over 3 days. The participants of the comparator group will receive a 3 day regimen of once daily oral AS (4mg/kg) combined with once daily AQ (10mg/kg). Endpoints: The primary endpoint is the number of adverse events (AE) after drug intake until day 28. Secondary endpoints are the number of serious adverse events (SAE), adequate clinical and parasitological response (ACPR) rate on day 28, clinical and parasitological failure rates on day 3, 7, 14 and 28, changes in haematocrit until day 28, and fever and parasite clearance time.
Interventions
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Inclusion criteria
* 6-10 year old children * Ability to swallow tablets * Uncomplicated malaria caused by P. falciparum * Asexual parasites ≥ 2000/µl and \< 200000/µl * Axillary temperature ≥ 37.5°C * Burkinabe nationality * Informed consent
Exclusion criteria
* Complicated or severe malaria * Any apparent significant disease * Anaemia (haematocrit \< 21%) * Treated in the same trial before * Antimalarial treatment prior to inclusion (last three days), except children having been treated with chloroquine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11) | — |
Secondary
| Measure | Time frame |
|---|---|
| ACPR rate until D28 | — |
| Early treatment failure (ETF) rate | — |
| Late clinical failure (LCF) rate at D14 and D28 | — |
| Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period | — |
| Fever clearance time | — |
| Parasite clearance time | — |
| Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline | — |
| Late parasitological failure (LPF) rate at D14 and D28 | — |
Countries
Burkina Faso
Outcome results
None listed