Clincosm LogoSign in Get a demo

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

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT00545935
Collaborator
(none)
186
Enrollment
1
Location
3
Arms
3
Duration (Months)
61.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Methylenblue-Amodiaquine (MB-AQ)
  • Drug: Methylenblue-Artesunate (MB-AS)
  • Drug: Artesunate-Amodiaquine (AS-AQ)
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2007
Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of observed and self-reported non-serious adverse events over the 28 days observation period [28 days]

Secondary Outcome Measures

  1. Incidence of serious adverse events (SAE) and the adequate clinical and parasitological response rate (ACPR) [28 days]

  2. Early treatment failure (ETF) rate [28 days]

  3. Late clinical failure (LCF) rate at D14 and D28 [28 days]

  4. Late parasitological failure (LPF) rate at D14 and D28 [28 days]

  5. Fever clearance time [28 days]

  6. Parasite clearance time [28 days]

  7. Change in haematocrit after 2,14 and 28 days compared to baseline [28 days]

  8. MB whole blood concentrations on D3,5 or 7 compared to concentrations after the first dose [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 59 Months
Sexes Eligible for Study:
All
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

Locations

Site City State Country Postal Code
1 Centre de Recherche en Sante de Nouna Nouna Burkina Faso

Sponsors and Collaborators

  • Heidelberg University

Investigators

  • Principal Investigator: Olaf Mueller, Prof., Heidelberg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00545935
Other Study ID Numbers:
  • MB-2007b
First Posted:
Oct 17, 2007
Last Update Posted:
Feb 3, 2009
Last Verified:
Feb 1, 2009
Additional relevant MeSH terms:
Malaria
Artesunate
Amodiaquine

Study Results

No Results Posted as of Feb 3, 2009