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

Sponsored by:	Dafra Pharma
Information provided by:	Dafra Pharma
ClinicalTrials.gov Identifier:	NCT00484900

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 III

MedlinePlus related topics: Malaria

Drug Information available for: Pyrimethamine Artesunate Sulfalene Artemisinin Artemether Benflumetol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Study ID Numbers:	2005/57/01
Study First Received:	June 8, 2007
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00484900
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

Study placed in the following topic categories:

Pyrimethamine
Artesunate
Benflumetol
Protozoan Infections
Artemether-lumefantrine combination
Artemisinine
Malaria

Malaria, Falciparum
Artemether
Folic Acid
Artemisinins
Sulfalene
Parasitic Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Coccidiosis
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists

Renal Agents
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Amebicides

ClinicalTrials.gov processed this record on January 16, 2009