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:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01872702
Eligibility Criteria:
OxTREC reference: 1017-13
Inclusion Criteria:
* Age ≥6 months, male or female,
* Written informed consent (by parent/guardian in case of children)
Exclusion Criteria:
* Pregnant women will not receive primaquine (urine pregnancy tests will be performed on women of appropriate age groups before drug administration at each TCE round)
* History of allergy or known contraindication to artemisinins, piperaquine or PQ
* Those who are, in the opinion of the study clinician, ill at the time of drug administration
OxTREC reference: 1015-13
Inclusion Criteria
* Age ≥6 months, male or female,
* Written informed consent (by legally acceptable representative in case of children)
* Healthy at the time of the survey or drug administration
* Not pregnant
Exclusion Criteria
* Significant non-compliance with study requirements
* Loss to follow up
* Suspected severe adverse events
* Severe illness
OxTREC reference: 23-15
Part 1. qPCR survey for identification of potential TMT villages;
Inclusion criteria:
* Males and females 18 and above
* Written informed consent
Exclusion criteria:
* Pregnant women in their first trimester
* Presence of any acute severe illness at the time of survey
Part 2. TMT villages will be given directly observed therapy (DOT) with DP for 3 days and PQ (0.25 mg/kg) will be given on day 1
Inclusion criteria for TMT
* Age ≥one year, male and female,
* Willing to provide consent for those 18 years and above. For children 10-18 years old, parents/guardians must provide consent, and the children must provide assent. For children below 10 years old, the parents/guardians must provide consent.
Exclusion criteria for TMT
* History of allergy or known contraindication to artemisinins, piperaquine or PQ.
* Refusal of treatment.
* Pregnant women in their 1st trimester.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT01872702
Study Brief:
Protocol Section:
NCT01872702