Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02851108
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-06-28
Brief Title:
Methylene Blue Against Falciparum Malaria in Burkina Faso
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Safety of Artesunate-amodiaquine Combined With Methylene Blue or Primaquine for Falciparum Malaria Treatment in African Children A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BlueACTn
Brief Summary:
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
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
Detailed Description:
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
1 AS-AQ-MB
2 AS-AQ-PQ
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 mgkg 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 2 025 mgkg
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
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
1 AS-AQ-MB
2 AS-AQ-PQ
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 mgkg 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 2 025 mgkg
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None