Status:
COMPLETED
Chlorproguanil/Dapsone Compared With Chloroquine and SP for Vivax Malaria
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
HealthNet TPO
Conditions:
Malaria
Vivax Malaria
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
To determine whether two cheap antifolates (chlorproguanil-dapsone and sulfadoxine-pyrimethamine) which work against falciparum malaria in this region are sufficiently effective against vivax malaria ...
Detailed Description
Objectives: Primary: To evaluate the comparative efficacy of chlorproguanil / dapsone with sulfadoxine-pyrimethamine for the treatment of vivax malaria in Pakistan and eastern Afghanistan. Secondar...
Eligibility Criteria
Inclusion
- Presentation at BHU or clinic with probable clinical malaria.
- Infection with P. vivax, confirmed by microscopy.
- Age 3 years or older (no restriction on upper age limit).
- Written or witnessed verbal consent obtained from the patient or the patients parent or guardian.
- Married women of child bearing age confirmed to be non-pregnant at outset and willing to remain thus for the duration of the study.
- Willingness to comply with the requirements of the protocol and particularly to provide venous and thumb prick blood samples.
- Available for follow up for the duration of the study and not less than 6 months.
- Willingness to report to the BHU or clinic if they feel unwell in the 6 months following completion (i.e. 7 months from enrolment date). NB these patients will only be those recruited up to 7 months before the end of the study period.
- Availability of G6PD status by willingness to be tested at admission.
Exclusion
- General condition requiring hospital admission.
- Evidence of any concomitant infection likely to mask treatment response at the time of presentation.
- Presence of any other underlying disease that compromises the diagnosis and the evaluation of the response to the study medication.
- History of allergy to sulphonamides, dapsone or chloroquine or hypersensitivity to biguanides (eg proguanil, chlorproguanil) sulphones (eg frusemide, thiazides, acetazolamide, and sulphonylureas) or any other tablet contents.
- Known methaemoglobin reductase deficiency and haemoglobin M.
- Treatment within the past twenty-eight days with sulfadoxine/pyrimethamine (Fansidar), sulfalene/pyrimethamine (Metakelfin), mefloquine-sulfadoxine-pyrimethamine (Fansimef); 21-days with mefloquine, or 7-days with amodiaquine, chloroquine, halofantrine, quinine (full course), primaquine, atovaquone - proguanil, artemisinin derivatives, co-artemether, trimethoprim, chloramphenicol, erythromycin, tetracycline or clindamycin.
- Visible jaundice.
- Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
- Severe anaemia (Hb\<7 g/dl).
- Other species of malaria seen.
- Pregnancy, assessed by pregnancy test in all married women of child-bearing age (age over 14 and under 50).
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00158561
Start Date
February 1 2004
End Date
March 1 2006
Last Update
January 12 2017
Active Locations (1)
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1
HealthNet International
Peshawar, Pakistan