A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali (LeDoxy-Mali)
Lymphedema, Lymphatic Filariasis, Filariasis
About this trial
This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, Lymphatic Filariasis, Filariasis, Doxycycline
Eligibility Criteria
Inclusion Criteria:
Patients eligible for the trial must comply with all of the following at randomization:
- 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
- Able to give informed consent to participate in the trial (forms to be attached)
- Resident in endemic area for five years or more
- Body weight >40 kg
- 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).
- Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
- No evidence of severe or systemic comorbidities except for features of filarial disease
- Normal laboratory profile (Appendix 3 investigations and the maximum or minimum limits in the case of hematological abnormalities - Site Specific)
- Consent to storage of blood samples for study
Exclusion Criteria:
Patients are ineligible to participate in the trial, if they have any of the following:
- No lymphedema or lymphedema stage 7
- Age < 14 years or > 65 years
- Body weight < 40 kg
- Pregnant or breastfeeding women
- 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)
- Clinical or laboratory evidence of hepatic or renal dysfunction or CNS disease
- Alcohol or drug abuse
- History of adverse reactions to doxycycline or other tetracyclines
- Patient has any situation or condition that may interfere with participation in the study as judged by the clinical investigator
Sites / Locations
- International Centers for Excellence in Research-Mali, Filariasis Res. Unit.
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Doxycycline
Placebo
The Doxycycline treated group will enroll 125 participants. 100 patients with Grades 1-3 lymphedema per study site (based on end point and duration) and up to 25 patients with grade 4-6 lymphedema/per study site. Each patient will receive Doxycycline hyclate 200 mg per day x 6 weeks for patients >50 kg or 100 mg per day for patients <50 kg).
The Placebo treated group will enroll 125 participants. 100 patients with Grades 1-3 lymphedema per study site (based on end point and duration) and up to 25 patients with grade 4-6 lymphedema/per study site. Each patient will receive matching tablets containing no active ingredients.