Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT00158561
Eligibility Criteria:
Inclusion Criteria:
1. Presentation at BHU or clinic with probable clinical malaria.
2. Infection with P. vivax, confirmed by microscopy.
3. Age 3 years or older (no restriction on upper age limit).
4. Written or witnessed verbal consent obtained from the patient or the patients parent or guardian.
5. Married women of child bearing age confirmed to be non-pregnant at outset and willing to remain thus for the duration of the study.
6. Willingness to comply with the requirements of the protocol and particularly to provide venous and thumb prick blood samples.
7. Available for follow up for the duration of the study and not less than 6 months.
8. 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.
9. Availability of G6PD status by willingness to be tested at admission.
Exclusion Criteria:
1. General condition requiring hospital admission.
2. Evidence of any concomitant infection likely to mask treatment response at the time of presentation.
3. Presence of any other underlying disease that compromises the diagnosis and the evaluation of the response to the study medication.
4. 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.
5. Known methaemoglobin reductase deficiency and haemoglobin M.
6. 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.
7. Visible jaundice.
8. Use of an investigational drug within 30 days or 5 half-lives whichever is the longer.
9. Severe anaemia (Hb\<7 g/dl).
10. Other species of malaria seen.
11. Pregnancy, assessed by pregnancy test in all married women of child-bearing age (age over 14 and under 50).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT00158561
Study Brief:
Protocol Section:
NCT00158561