NCT00484900

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,390

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2006

Shorter than P25 for phase_3

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2007

Completed
Last Updated

March 26, 2008

Status Verified

June 1, 2007

First QC Date

June 8, 2007

Last Update Submit

March 25, 2008

Conditions

Plasmodium Falciparum Malaria

Keywords

Open randomized multi-centre clinical trial in AfricaUncomplicated P. falciparum malariaArtemisinin-based Combination TherapyArtesunate + sulfalene + pyrimethamine24 hour treatmentArtemether + lumefantrine

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

Co-Arinate FDCDRUG
CoartemDRUG

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Cameroon Baptist Convention Clinic of Biyem-Assi

Yaoundé, Cameroon

Location

Health centres of Samako, Kolle and Bancoumane

Bamako, Mali

Location

Health centres Rwamagana and Muhima

Kigali, Rwanda

Location

Alhara Alola Health centre

New Halfa, Sudan

Location

Related Publications (1)

  • 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.

    PMID: 19366448DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 8, 2007

First Posted

June 11, 2007

Study Start

May 1, 2006

Study Completion

May 1, 2007

Last Updated

March 26, 2008

Record last verified: 2007-06

Locations

RW(1)CA(1)MA(1)SU(1)