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CompletedNCT00484900Updated Mar 26, 2008

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

A Phase 3 interventional study of Co-Arinate FDC and Coartem in Plasmodium Falciparum Malaria, sponsored by Dafra Pharma. Completed at 4 sites in 4 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2008-03-26.

Sponsored by Dafra Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,390
Allocation
Randomized
Ages
6 Months and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 1,390 is above the median of 220 across 1,027 interventional studies indexed under Malaria.

Browse Malaria studies →

Lead sponsor

Dafra Pharma is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,390 participants (actual)

Interventions

  • DrugCo-Arinate FDC
  • DrugCoartem
06

What researchers measure

Primary outcomes

  1. PCR corrected Adequate Clinical and Parasitological Response

    Time frame: on day 28 (follow-up period)

  2. Early treatment failure

    Time frame: between day 0 and day 3

  3. Late clinical failure

    Time frame: between day 4 and day 28

  4. Late parasitological failure

    Time frame: between day 7 and day 28

Secondary outcomes

  1. Parasitic clearance

    Time frame: 28 day follow-up period

  2. Fever clearance

    Time frame: 28 day follow-up period

  3. Parasitological re-infection

    Time frame: 28 day follow-up period

  4. Gametocyte carriage

    Time frame: 28 day follow-up period

  5. Safety - Adverse events

    Time frame: 28 day follow-up period

  6. Haemoglobin levels

    Time frame: 28 day follow-up period

  7. Clinical and biological tolerance (Haemogram + Lever tests)

    Time frame: 28 day follow-up period

07

Study locations

4 sites
  • Cameroon Baptist Convention Clinic of Biyem-Assi
    Yaounde, Cameroon
  • Health centres of Samako, Kolle and Bancoumane
    Bamako, Mali
  • Health centres Rwamagana and Muhima
    Kigali, Rwanda
  • Alhara Alola Health centre
    New Halfa, Sudan
08

References and documents

Publications

  • 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. PubMed 19366448 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00484900
Lead sponsor
Dafra Pharma
First posted
Jun 11, 2007
Start date
May 2006
Completion
May 2007
Last update
Mar 26, 2008

Study contacts

Issaka Sagara, Dr
principal investigator · University of Bamako, Mali
Wilfred F Mbacham, Dr
principal investigator · University Yaoundé, Cameroon
Ishag A Adam, Dr
principal investigator · University of Khartoum, Sudan
Stephen Rulisa, Dr
principal investigator · Kigali Central University Hospital, Rwanda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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