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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484900
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : March 26, 2008
Information provided by:
Dafra Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Malaria Drug: Co-Arinate FDC Drug: Coartem Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : May 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484900

Cameroon Baptist Convention Clinic of Biyem-Assi
Yaounde, Cameroon
Health centres of Samako, Kolle and Bancoumane
Bamako, Mali
Health centres Rwamagana and Muhima
Kigali, Rwanda
Alhara Alola Health centre
New Halfa, Sudan
Sponsors and Collaborators
Dafra Pharma
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 automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00484900     History of Changes
Other Study ID Numbers: 2005/57/01
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: June 2007

Keywords provided by Dafra Pharma:
Open randomized multi-centre clinical trial in Africa
Uncomplicated P. falciparum malaria
Artemisinin-based Combination Therapy
Artesunate + sulfalene + pyrimethamine
24 hour treatment
Artemether + lumefantrine

Additional relevant MeSH terms:
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether-lumefantrine combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Antiplatyhelmintic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action