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

Plasmodium Falciparum Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484900
• Other study ID #: 2005/57/01
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2007
• Last updated: March 25, 2008
• Start date: May 2006
• Est. completion date: May 2007

Study information

• Verified date: June 2007
• Source: Dafra Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mali: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1390
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 ß HCG test),

• use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Drug:
• Co-Arinate FDC

• Coartem

Locations

Country	Name	City	State
Cameroon	Cameroon Baptist Convention Clinic of Biyem-Assi	Yaounde
Mali	Health centres of Samako, Kolle and Bancoumane	Bamako
Rwanda	Health centres Rwamagana and Muhima	Kigali
Sudan	Alhara Alola Health centre	New Halfa

Sponsors (1)

Lead Sponsor	Collaborator
Dafra Pharma

Countries where clinical trial is conducted

Cameroon,  Mali,  Rwanda,  Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR corrected Adequate Clinical and Parasitological Response		on day 28 (follow-up period)
Primary	Early treatment failure		between day 0 and day 3
Primary	Late clinical failure		between day 4 and day 28
Primary	Late parasitological failure		between day 7 and day 28
Secondary	Parasitic clearance		28 day follow-up period
Secondary	Fever clearance		28 day follow-up period
Secondary	Parasitological re-infection		28 day follow-up period
Secondary	Gametocyte carriage		28 day follow-up period
Secondary	Safety - Adverse events		28 day follow-up period
Secondary	Haemoglobin levels		28 day follow-up period
Secondary	Clinical and biological tolerance (Haemogram + Lever tests)		28 day follow-up period