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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT02929134
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for the trial must comply with all of the following at randomization:
1. Age ≥ 14 years and \<65 years, male or non-pregnant women of childbearing-potential using an approved, effective method of contraception before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo
2. Able to give informed consent to participate in the trial (forms to be attached)
3. Resident in endemic area for five years or more
4. Body weight \>40 kg
5. Lymphedema of a limb Grade 1-6 measured on a 7-point scale. (Appendix 1 for explanation of the grading system (Dreyer G et al. 2002).
6. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
7. No evidence of severe or systemic comorbidities except for features of filarial disease
8. Normal laboratory profile (Appendix 3 investigations and the maximum or minimum limits in the case of hematological abnormalities - Site Specific)
9. Consent to storage of blood samples for study
Exclusion Criteria:
Patients are ineligible to participate in the trial, if patients have any of the following:
1. No lymphedema or lymphedema stage 7
2. Age \< 14 years or \> 65 years
3. Body weight \< 40 kg
4. Pregnant or breastfeeding women
5. Women of childbearing potential not using an agreed method of contraception. (A pregnancy test will be conducted as part of the screening process to exclude pregnancy and repeated at 3 and 8 weeks. In addition, women of childbearing potential will be counseled against pregnancy during the treatment period)
6. Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease
7. Alcohol or drug abuse
8. History of adverse reactions to doxycycline or other tetracyclines
9. Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT02929134
Study Brief:
Protocol Section:
NCT02929134