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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:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00545935
First received: October 16, 2007
Last updated: February 2, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Malaria
 Drug: Methylenblue-Amodiaquine (MB-AQ)
Drug: Methylenblue-Artesunate (MB-AS)
Drug: Artesunate-Amodiaquine (AS-AQ)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 186
Study Start Date: July 2007
Estimated Study Completion Date: October 2007
Arms Assigned Interventions
Active Comparator: 1-Methylenblue-Amodiaquine Drug: Methylenblue-Amodiaquine (MB-AQ)
For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ
Active Comparator: 2-Methylenblue-Artesunate 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
Active Comparator: 3-Artesunate-Amodiaquine Drug: Artesunate-Amodiaquine (AS-AQ)
For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545935

Locations
Burkina Faso
Centre de Recherche en Sante de Nouna
Nouna, Burkina Faso
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Olaf Mueller, Prof. University of Heidelberg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00545935     History of Changes
Other Study ID Numbers: MB-2007b
Study First Received: October 16, 2007
Last Updated: February 2, 2009
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Amodiaquine
Artesunate
Methylene Blue
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Amebicides

ClinicalTrials.gov processed this record on May 16, 2013