A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka
Status:
Completed
Trial end date:
2020-06-15
Target enrollment:
Participant gender:
Summary
Current lymphedema management protocols are based on the use of simple measures of hygiene
(regular washing with soap and water, skin and nail care), use of topical antibiotics or
antifungal agents, exercise and footwear. This is considered the "standard of care" in most
endemic countries in the absence of any structured treatment programs. Previous controlled
clinical trials and extensive field experience have shown the benefit of these measures in
reducing the frequency of attacks of acute dermato-lymphangio-adenitis (ADLA) that drive the
progression of lymphedema.
In the present study, the progression of lymphedema in a group of patients who receive a
six-week course of doxycycline will be compared with that of a group who receives doxycycline
"look-alike" placebo tablets. However, both groups will be enrolled into a standardized
"regimen of hygiene" described above. Thus, patients enrolled in the "placebo" group also
will receive the current standard of care, and the placebo used in the study will help to
identify the benefits of doxycycline on a background of simple hygiene measures. The regimens
will be explained to all participants who will be trained to use established standardized
methods of hygiene and be effectively applying it prior to the initiation of the drug
treatment. In addition, patients will be evaluated at 3, 6, 12 and 24 months.. A common,
generic SOP with handouts that describes methods and the training schedule will be used so
that similar methods are employed across all sites.
Phase:
Phase 3
Details
Lead Sponsor:
The Task Force for Global Health
Collaborator:
United States Agency for International Development (USAID)