Status:
COMPLETED
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria, Falciparum
Eligibility:
All Genders
12-14 years
Phase:
PHASE3
Brief Summary
Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare pr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Acute, uncomplicated P.falciparum malaria, microscopically confirmed
- Temperature at screening of 37.5oC or or more or confirmed history of fever within previous 24 hours
- Weigh 7.5kg or over
- Screening haemoglobin (Hb) of 7g/dl or over, or haematocrit of 25% or more(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 has been obtained from parent or guardian
- Assent is given by a child aged 12 years or over, 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, artemether, lumefantrine)
- Known allergy to biguanides, sulphones, sulphonamides, artemisinin derived products or aminoalcohol drugs
- Known history of G6PD deficiency
- Infants with a history of hyperbilirubinaemia during the neonatal period
- Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the WHO (World Health Organization) list of essential drugs
- Evidence of any concomitant infection at the time of presentation (including P. vivax, P. ovale and P. malariae)
- 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 atovoquone/proguanil, halofantrine; 14-days with chlorproguanil/dapsone, or 7-days with quinine (full course), proguanil, artemisinins, 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 age, who have had a positive pregnancy test at screening, 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
1395 Patients enrolled
Trial Details
Trial ID
NCT00344006
Start Date
June 1 2006
End Date
August 1 2007
Last Update
December 5 2016
Active Locations (9)
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1
GSK Investigational Site
Bobo-Dioulasso, Burkina Faso
2
GSK Investigational Site
Kintampo, Ghana
3
GSK Investigational Site
Eldoret, Kenya
4
GSK Investigational Site
Kilifi, Kenya