Last updated: 11/07/2018 18:54:33

Safety and Efficacy Dose of Artesunate Used in Combination with LAPDAP Treatment of Uncomplicated Falciparum Malaria

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GSK study ID
SB-714703/003
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Clinicaltrials.gov ID
NCT00519467
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open, randomised, multi-centre dose ranging phase II study to evaluate LAPDAP in combination with three different doses of artesunate
Trial description: Drug resistance to a range of antimalarial treatments has become widespread in Africa, South East Asia and South America. Because the rapid spread of drug resistance threatens a public health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria policy of using Artemisinin-based combination therapies (ACT), there is a need to develop new, safe, effective and affordable ACT.
Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment of uncomplicated falciparum malaria in Africa.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Chlorproguanil-dapsone-artesunate (CDA)
    • Enrollment:
    120
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Malaria
    Product
    artesunate, artesunate/chlorproguanil/dapsone, chlorproguanil, dapsone
    Collaborators
    Not applicable
    Study date(s)
    June 2003 to February 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 60 years
    Accepts healthy volunteers
    No
    • Presentation to a healthcare facility with probable uncomplicated clinical malaria
    • Adults aged between 18 and 60 years , or children aged between 12 and 120 months
    • Features of severe/complicated falciparum malaria
    • Known allergy to sulphonamides
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Presentation to a healthcare facility with probable uncomplicated clinical malaria
    • Adults aged between 18 and 60 years , or children aged between 12 and 120 months
    • Weight between 5 and 85kg
    • Pure [on microscopic grounds] screening P. falciparum parasitaemia in children from 25,000 to 100,000ul-1, or in adults from 10,000 to 100,000ul-1. [The parasitaemia range for adults was originally set at 25,000 to 100,000µl-1 and changed to 10,000 to 100,000µl-1 in protocol amendment 3 dated 05 May 2004]
    • Written or oral witnessed consent obtained from subject, parent or guardian
    • Compliance with the requirements of the protocol which include a hospital stay of 4 days and 3 nights and regular blood samples by finger-prick (children) or via a cannula (adults)
    • A negative pregnancy test for women of child-bearing age on enrolment
    Exclusion criteria:
    • Features of severe/complicated falciparum malaria
    • Known allergy to sulphonamides
    • Evidence of any concomitant infection at the time of presentation (including P. ovale and P. malaria)
    • Any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis and bacterial infection)
    • Treatment in the 28-days prior to screening with sulfadoxine/pyrimethamine (FANSIDAR, CELOXINE), sulfalene/pyrimethamine (METAKELFIN), mefloquine-sulfadoxinepyrimethamine (FANSIMET), chloroquine* (NIVAQUINE); treatment in the 21-days prior to screening with mefloquine, or 7-days prior to screening with amodiaquine, halofantrine, quinine (full course), atovaquone
    • proguanil, artemisinins, co-artemether, tetracycline or clindamycin, or treatment for 5 half-lives prior to screening with drugs that have a potential anti-malarial activity (e.g. co-trimoxazole in the previous 60 hours)
    • Use of an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening
    • Previous participation in this study
    • A positive pregnancy test at enrolment, women of child-bearing age who do not take a pregnancy test or female subjects who are breast-feeding an infant for the duration of the study

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    BLANTYRE, Malawi, 30096,BLANTYRE 3
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Banjul, Gambia
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-10-02

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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