Last updated: 11/07/2018 18:54:33
Safety and Efficacy Dose of Artesunate Used in Combination with LAPDAP Treatment of Uncomplicated Falciparum Malaria
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
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.
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