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Completed

NCT Number: NCT00484900

Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments 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.

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Key information

Conditions

Plasmodium Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cameroon Baptist Convention Clinic of Biyem-Assi, Yaoundé, Cameroon

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Co-Arinate FDC

Drug

Coartem

Drug

Primary outcomes

  1. PCR corrected Adequate Clinical and Parasitological Response

    Time frame: on day 28 (follow-up period)

  2. Early treatment failure

    Time frame: between day 0 and day 3

  3. Late clinical failure

    Time frame: between day 4 and day 28

  4. Late parasitological failure

    Time frame: between day 7 and day 28

Secondary outcomes

  1. Parasitic clearance

    Time frame: 28 day follow-up period

  2. Fever clearance

    Time frame: 28 day follow-up period

  3. Parasitological re-infection

    Time frame: 28 day follow-up period

  4. Gametocyte carriage

    Time frame: 28 day follow-up period

  5. Safety - Adverse events

    Time frame: 28 day follow-up period

  6. Haemoglobin levels

    Time frame: 28 day follow-up period

  7. Clinical and biological tolerance (Haemogram + Lever tests)

    Time frame: 28 day follow-up period

Sponsors and collaborators

Lead sponsor

Dafra Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Jun 11, 2007
Registry last updated
Mar 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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