Status:
COMPLETED
Chlorproguanil-Dapsone-Artesunate (CDA) Versus Chlorproguanil-Dapsone (LAPDAP) For Uncomplicated Malaria
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
CDA is a combination of chlorproguanil, dapsone and artesunate, being developed in a public-private partnership with the Medicines for Malaria Venture (MMV), World Health Organisation (WHO-TDR) and ac...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Acute, uncomplicated P.falciparum malaria, microscopically confirmed infection.
- Temperature at screening of 37.5oC or over or confirmed history of fever within previous 24-hours.
- Weight 7.5kg or over , no upper weight limit.
- Screening haemoglobin (Hb) of 7g/dl, or more or haematocrit of 25% or over(if Hb not available at screening).
- Willingness to comply with the study visits and procedures, as outlined in the informed consent form.
- Written or oral witnessed consent obtained from subject, parent or guardian.
- Assent is given by a child aged 12 to \<18years, in addition to the consent of their parent or guardian.
- Exclusion criteria:
- Features of severe/complicated falciparum malaria.
- Hypersensitivity to active substances (chlorproguanil, dapsone, artesunate), or excipients of the investigational products.
- Known allergy to biguanides, sulphones, sulphonamides or artemisinin derived products.
- Known history of G6PD deficiency.
- Infants with a history of hyperbilirubinaemia during the neonatal period.
- Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae).
- Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs.
- Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).
- Malnutrition, defined as a child whose weight-for-height is below -3 standard deviations or less than 70% of the median of the NCHS/WHO normalised reference values
- Treatment within the past three months with mefloquine or mefloquine-sulphadoxine-pyrimethamine; twenty-eight days with sulphadoxine/pyrimethamine, sulfalene/pyrimethamine, lumefantrine or artemether/lumefantrine, amodiaquine, atovaquone or atovaquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinin, tetracycline doxycycline or clindamycin.
- Positive sulphadoxine/pyrimethamine urine screen for 'unknown' antimalarial drug use in prior 28-days.
- Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
- Previous participation in this study.
- Female subjects of child-bearing potential who have had a positive pregnancy test at enrolment, or do not give their consent to take a pregnancy test.
- Female subjects who will be breast-feeding an infant for the duration of the study.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00371735
Start Date
April 1 2006
End Date
May 1 2007
Last Update
December 5 2016
Active Locations (7)
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1
GSK Investigational Site
Ouagadougou, Burkina Faso
2
GSK Investigational Site
Kumasi, Ghana
3
GSK Investigational Site
Bamako, Mali
4
GSK Investigational Site
Ile-Ife, Nigeria