MedTrace Logo

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

NCT00545935 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2009-02-03

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Olaf Mueller, Prof. · Heidelberg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Completion
2007-10-31

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00545935 on ClinicalTrials.gov