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

This study has been completed.
Sponsor:
Information provided by:
Dafra Pharma
ClinicalTrials.gov Identifier:
NCT00484900
First received: June 8, 2007
Last updated: March 25, 2008
Last verified: June 2007
  Purpose

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 Intervention Phase
Plasmodium Falciparum Malaria
Drug: Co-Arinate FDC
Drug: Coartem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dafra Pharma:

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

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

Enrollment: 1390
Study Start Date: May 2006
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484900

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

No publications provided by Dafra Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00484900     History of Changes
Other Study ID Numbers: 2005/57/01
Study First Received: June 8, 2007
Last Updated: March 25, 2008
Health Authority: Mali: Ministry of Health

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
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014