Malaria
Conditions
Keywords
dose-ranging study, SB-714703, artesunate,, malaria, CDA,, chlorproguanil,, dapsone,
Brief summary
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.
Interventions
DRUGChlorproguanil-dapsone-artesunate (CDA)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment differences between 1,2, or 4mg/kg artesunate with a fixed dose of Chlorproguanil-dapsone (LAPDAP), as measured by determination of PC90 (time to achieve reduction of parasitaemia by 90% of baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy endpoint is parasite viability (the proportion of ring-form parasites developing to schizonts) determined from rich adult data and confirmed with more sparse child data | — |
Countries
Malawi, The Gambia
Outcome results
None listed