Health Condition 1: B741- Filariasis due to Brugia malayi
Conditions
Interventions
Intervention1: Doxycycline and Placebo: Two arms
Active comparator: Doxycycline hyclate 200 mg per day x 6 weeks for patients 50 kg or 100 mg per day for patients 50 kg)
Placebo comparator: Placebo M
Sponsors
Task Force for Global Health
Eligibility
Inclusion criteria
Inclusion criteria: -Resident in endemic area for filariasis for >5yrs -Body weight >40Kg -Lymphedema of a limb stage 1-6 measured on a 7 point scale -Able to give informed consent -Ability to use established methods of hygiene -Normal laboratory profile
Exclusion criteria
Exclusion criteria: -No lymphedema or lymphedema stage 7 -Age 65 years -Body weight -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement or halt of progression (Lack of progression) of lymphedema when examined 24 months after treatment onsetTimepoint: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| -Improvement or halt of progression (Lack of progression) of LE -Change of LE stages (reduction or increase) compared to baseline -Change in the circumference of the affected limb from baseline -Reduction in the frequency of acute ADLA attacks -Changes in skin thickness compared to the baseline -Change in angiogenic, pro-fibrotic or pro-inflammatory biomarkers Timepoint: -Improvement or halt of progression of LE 12 months after treatment onset -Improvement of LE 12 and 24 months -Change of LE stages compared to baseline assessed at 12 and 24 months -Change in the circumference of the affected limb from baseline -Reduction in acute ADLA attacks 0-12 months,12-24 months -Changes in skin thickness at 12 and 24 months compared to the baseline -Change in angiogenic, pro-fibrotic or pro-inflammatory biomarkers at 12 and 24 months | — |
Countries
India, Mali, Sri Lanka
Contacts
Public ContactSuma Krishnasastry
Govt T D Medical College
Outcome results
None listed