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Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

NCT00484900 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1390

Last updated 2008-03-26

No results posted yet for this study

Summary

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Co-Arinate FDC

DRUG

Coartem

Sponsors & Collaborators

  • Dafra Pharma

    lead INDUSTRY

Principal Investigators

  • Issaka Sagara, Dr · University of Bamako, Mali

  • Wilfred F Mbacham, Dr · University Yaoundé, Cameroon

  • Ishag A Adam, Dr · University of Khartoum, Sudan

  • Stephen Rulisa, Dr · Kigali Central University Hospital, Rwanda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Completion
2007-05-31

Countries

  • Cameroon
  • Mali
  • Rwanda
  • Sudan

Study Locations

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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 NCT00484900 on ClinicalTrials.gov