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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00545935
First received: October 16, 2007
Last updated: February 2, 2009
Last verified: February 2009

October 16, 2007
February 2, 2009
July 2007
Not Provided
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Incidence of observed and self-reported non-serious adverse events over the 28 days observation period
Complete list of historical versions of study NCT00545935 on ClinicalTrials.gov Archive Site
  • Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Early treatment failure (ETF) rate [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Late clinical failure (LCF) rate at D14 and D28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Late parasitological failure (LPF) rate at D14 and D28 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Fever clearance time [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Parasite clearance time [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Change in haematocrit after 2,14 and 28 days compared to baseline [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
The number of serious adverse events (SAE), the adequate clinical and parasitological response rate (ACPR).
Not Provided
Not Provided
 
Safety and Efficacy of Methylene Blue Combined With Amodiaquine or Artesunate for Malaria Treatment in Children of Burkina Faso
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Malaria
  • Drug: Methylenblue-Amodiaquine (MB-AQ)
    For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
  • Drug: Methylenblue-Artesunate (MB-AS)
    3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days
  • Drug: Artesunate-Amodiaquine (AS-AQ)
    For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.
  • Active Comparator: 1-Methylenblue-Amodiaquine
    Intervention: Drug: Methylenblue-Amodiaquine (MB-AQ)
  • Active Comparator: 2-Methylenblue-Artesunate
    Intervention: Drug: Methylenblue-Artesunate (MB-AS)
  • Active Comparator: 3-Artesunate-Amodiaquine
    Intervention: Drug: Artesunate-Amodiaquine (AS-AQ)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
October 2007
Not Provided

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
Both
6 Months to 59 Months
Not Provided
Contact information is only displayed when the study is recruiting subjects
Burkina Faso
 
NCT00545935
MB-2007b
Not Provided
Not Provided
Heidelberg University
Not Provided
Principal Investigator: Olaf Mueller, Prof. Heidelberg University
Heidelberg University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP