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
  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:


Further study details as provided by Heidelberg University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heidelberg University
Investigators
Principal Investigator: Olaf Mueller, Prof. Heidelberg University
  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
Artesunate
Artemisinins
Amodiaquine
Methylene Blue
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014