Safety and Efficacy of Methylene Blue Combined With Artesunate or Amodiaquine for Malaria Treatment in Children of Burkina Faso: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT00354380|
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : October 24, 2006
|Condition or disease||Intervention/treatment||Phase|
|Malaria||Drug: Methylene blue Drug: Artesunate Drug: Amodiaquine||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2006|
|Study Completion Date :||November 2006|
- Incidence of observed and self-reported non-serious adverse events over the 28 days observation period (definition chapter 11)
- Incidence of serious adverse events (definition: chapter 11) over the 28 days observation period
- ACPR rate until D28
- Early treatment failure (ETF) rate
- Late clinical failure (LCF) rate at D14 and D28
- Late parasitological failure (LPF) rate at D14 and D28
- Fever clearance time
- Parasite clearance time
- Change in haematocrit after 2, 3, 7, 14 and 28 days compared to baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00354380
|Nouna District Hospital|
|Nouna, Burkina Faso|
|Principal Investigator:||Olaf Mueller, MD, MPH||Heidelberg University|
|Principal Investigator:||Peter Meissner, MD, MSc Trop Paed||Heidelberg University|