Methylene Blue Against Falciparum Malaria in Burkina Faso (BlueACTn)
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|ClinicalTrials.gov Identifier: NCT02851108|
Recruitment Status : Completed
First Posted : August 1, 2016
Results First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Safety of artesunate-amodiaquine combined with methylene blue or primaquine for falciparum malaria treatment in African children: A randomised controlled trial
Elimination has become the goal of malaria programmes in an increasing number of endemic countries and regions. As resistance against artemisinin compounds has recently started to emerge in South-East Asia, there is a clear need to develop alternative malaria drug combinations. Adding another anti-malarial with a short half-life such as methylene blue to standard ACT (artemisinin-based combination therapy) could be a strategy to prevent artemisinin resistance development. Moreover, adding a gametocytocidal drug to ACT reduces the probability of transmission of P. falciparum parasites including drug-resistant parasites.
Objectives: The primary objective of this trial is to investigate the safety of artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) compared to AS - AQ - primaquine (PQ) in young children with uncomplicated falciparum malaria in Burkina Faso.
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum||Drug: Methylene Blue Drug: Primaquine||Phase 2|
The overall goal of the underlying research project is to develop a MB-based first-line drug combination regimen against uncomplicated falciparum malaria in SSA.
The primary objective of this study is: To study the safety of the triple combination AS-AQ-MB compared to AS-AQ-PQ in the treatment of uncomplicated falciparum malaria in young African children. The secondary objective of this study is: To study the efficacy of this MB-based triple combination in comparison with standard ACT-PQ in the treatment of uncomplicated falciparum malaria in young African children.
It is a mono-center, open randomised controlled non-inferiority study in children with uncomplicated falciparum malaria in Burkina Faso. Patients will be randomised to two treatment groups (arms):
Study population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso.
Sample size: 100 patients (50 per study arm).
Treatment: The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB (15 mg/kg) over a three days period. The control group will receive once daily a fixed dose AS-AQ over three days combined with a single dose of PQ on day 2 (0.25 mg/kg).
Endpoints: Primary endpoint is the haemoglobin value on day 7 compared to baseline. Secondary endpoints are adverse events (AE), adequate clinical and parasitological response (ACPR) rate (PCR-corrected for recrudescences), as well as gametocyte prevalence and density.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Artesunate-amodiaquine Combined With Methylene Blue or Primaquine for Falciparum Malaria Treatment in African Children: A Randomised Controlled Trial|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||February 2017|
Once daily a fixed dose artesunate-amodiaquine formulation combined with once daily methylene blue (15 mg/kg) over a three days period.
Drug: Methylene Blue
50 patients will receive methylene blue
Other Name: 3,7-bis(Dimethylamino)-phenothiazine-5-ium chloride
Active Comparator: AS-AQ-PQ
Once daily a fixed dose artesunate-amodiaquine over three days combined with a single dose of primaquine on day 2 (0.25 mg/kg).
50 patients will receive primaquine
Other Name: (±)-N4-(6-Methoxychinolin-8-yl)pentan-1,4-diamine
- Change in Haemoglobin Compared to the Baseline [ Time Frame: 7 days ]Haemoglobin concentrations will be measured in the field using a HemoCue® (HemoCue® AB, Angelholm, Sweden)
- Gametocyte Prevalence [ Time Frame: 28 days ]measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
- Adverse Events (AE) [ Time Frame: 28 days ]Reports of observed or self-reported adverse event
- Mothers/Caretakers Questionnaire on Acceptance [ Time Frame: 14 days ]Acceptance of the different treatment regimens by mothers/caretakers
- Gametocyte Density [ Time Frame: 28 days ]measured microscopically at baseline and on day 1, 2, 3, 7, 14, and 28 of follow-up
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): NCT02851108
|Nouna, Burkina Faso|
|Principal Investigator:||Olaf Müller, Prof. Dr.||Heidelberg University|