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

March 25, 2008 updated by: Dafra Pharma

Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cameroon
      • Yaounde, Cameroon
        • Cameroon Baptist Convention Clinic of Biyem-Assi
  • Mali
      • Bamako, Mali
        • Health centres of Samako, Kolle and Bancoumane
  • Rwanda
      • Kigali, Rwanda
        • Health centres Rwamagana and Muhima
  • Sudan
      • New Halfa, Sudan
        • Alhara Alola Health centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age at least 6 months,
  • weight at least 5 kg,
  • residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
  • able to receive oral treatment,
  • having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
  • suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.

Exclusion Criteria:

  • presence of severe or complicated malaria (WHO 2000),
  • severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
  • allergic to one of the drugs involved in this study,
  • pregnant (reported pregnancy, detected clinically or with the β HCG test),
  • use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCR corrected Adequate Clinical and Parasitological Response
Time Frame: on day 28 (follow-up period)
on day 28 (follow-up period)
Early treatment failure
Time Frame: between day 0 and day 3
between day 0 and day 3
Late clinical failure
Time Frame: between day 4 and day 28
between day 4 and day 28
Late parasitological failure
Time Frame: between day 7 and day 28
between day 7 and day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Parasitic clearance
Time Frame: 28 day follow-up period
28 day follow-up period
Fever clearance
Time Frame: 28 day follow-up period
28 day follow-up period
Parasitological re-infection
Time Frame: 28 day follow-up period
28 day follow-up period
Gametocyte carriage
Time Frame: 28 day follow-up period
28 day follow-up period
Safety - Adverse events
Time Frame: 28 day follow-up period
28 day follow-up period
Haemoglobin levels
Time Frame: 28 day follow-up period
28 day follow-up period
Clinical and biological tolerance (Haemogram + Lever tests)
Time Frame: 28 day follow-up period
28 day follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dafra Pharma

Investigators

  • Principal Investigator: Issaka Sagara, Dr, University of Bamako, Mali
  • Principal Investigator: Wilfred F Mbacham, Dr, University Yaoundé, Cameroon
  • Principal Investigator: Ishag A Adam, Dr, University of Khartoum, Sudan
  • Principal Investigator: Stephen Rulisa, Dr, Kigali Central University Hospital, Rwanda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

March 26, 2008

Last Update Submitted That Met QC Criteria

March 25, 2008

Last Verified

June 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005/57/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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