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

NCT ID: NCT00545935

Last Updated: 2009-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-10-31

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1-Methylenblue-Amodiaquine

Group Type: ACTIVE_COMPARATOR

Methylenblue-Amodiaquine (MB-AQ)

Intervention Type: DRUG

For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ

2-Methylenblue-Artesunate

Group Type: ACTIVE_COMPARATOR

Methylenblue-Artesunate (MB-AS)

Intervention Type: DRUG

3 days once daily 4 mg/kg AS accompanied by twice daily 10 mg/kg MB given over 7 days

3-Artesunate-Amodiaquine

Group Type: ACTIVE_COMPARATOR

Artesunate-Amodiaquine (AS-AQ)

Intervention Type: DRUG

For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

Interventions

Methylenblue-Amodiaquine (MB-AQ)

For 3 days twice daily 10 mg/kg MB accompanied by once daily 10 mg/kg AQ

Intervention Type: 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

Intervention Type: DRUG

Artesunate-Amodiaquine (AS-AQ)

For 3 days once daily 10 mg/kg AQ accompanied by 4mg/kg AS.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Olaf Mueller, Prof.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Centre de Recherche en Sante de Nouna

Nouna, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

MB-2007b

Identifier Type: -

Identifier Source: org_study_id