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

Sponsor

Dafra Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00484900

Collaborator

(none)

1,390

Enrollment

Locations

Duration (Months)

347.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 1, 2006

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Cameroon Baptist Convention Clinic of Biyem-Assi	Yaounde	Cameroon
2	Health centres of Samako, Kolle and Bancoumane	Bamako	Mali
3	Health centres Rwamagana and Muhima	Kigali	Rwanda
4	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