Clinical trial NCT00484900: Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasmodium Falciparum Malaria
Keywords: Open randomized multi-centre clinical trial in Africa
Uncomplicated P. falciparum malaria
Artemisinin-based Combination Therapy
Artesunate + sulfalene + pyrimethamine
24 hour treatment
Artemether + lumefantrine
Lead sponsor: Dafra Pharma
Sponsor class: INDUSTRY
First posted: 2007-06-11
Enrollment: 1390
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: PCR corrected Adequate Clinical and Parasitological Response
timeFrame: on day 28 (follow-up period)
measure: Early treatment failure
timeFrame: between day 0 and day 3
measure: Late clinical failure
timeFrame: between day 4 and day 28
measure: Late parasitological failure
timeFrame: between day 7 and day 28
Secondary outcomes:
measure: Parasitic clearance
timeFrame: 28 day follow-up period
measure: Fever clearance
timeFrame: 28 day follow-up period
measure: Parasitological re-infection
timeFrame: 28 day follow-up period
measure: Gametocyte carriage
timeFrame: 28 day follow-up period
measure: Safety - Adverse events
timeFrame: 28 day follow-up period
measure: Haemoglobin levels
timeFrame: 28 day follow-up period
measure: Clinical and biological tolerance (Haemogram + Lever tests)
timeFrame: 28 day follow-up period
Other outcomes:
Locations:
city: Yaounde
country: Cameroon
facility: Cameroon Baptist Convention Clinic of Biyem-Assi
city: Bamako
country: Mali
facility: Health centres of Samako, Kolle and Bancoumane
city: Kigali
country: Rwanda
facility: Health centres Rwamagana and Muhima
city: New Halfa
country: Sudan
facility: Alhara Alola Health centre
Study officials:
affiliation: University of Bamako, Mali
name: Issaka Sagara, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Yaoundé, Cameroon
name: Wilfred F Mbacham, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Khartoum, Sudan
name: Ishag A Adam, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Kigali Central University Hospital, Rwanda
name: Stephen Rulisa, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sagara I, Rulisa S, Mbacham W, Adam I, Sissoko K, Maiga H, Traore OB, Dara N, Dicko YT, Dicko A, Djimde A, Jansen FH, Doumbo OK. Efficacy and safety of a fixed dose artesunate-sulphamethoxypyrazine-pyrimethamine compared to artemether-lumefantrine for the treatment of uncomplicated falciparum malaria across Africa: a randomized multi-centre trial. Malar J. 2009 Apr 14;8:63. doi: 10.1186/1475-2875-8-63.