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A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka

NCT02929134 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

  • Lymphedema
  • Lymphatic Filariasis
  • Filariasis

Interventions

DRUG

Doxycycline

Once daily tablet for 6 weeks: Doxycycline hyclate 200 mg per day x 6 weeks for patients \>50 kg or 100 mg per day for patients \<50 kg)

DRUG

Placebo

Once daily tablet for 6 weeks: matching tablets containing no active ingredients

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • The Task Force for Global Health

    lead OTHER

Principal Investigators

  • Eric Ottesen, MD · The Task Force for Global Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-16
Primary Completion
2020-06-15
Completion
2020-06-15

Countries

  • Sri Lanka

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929134 on ClinicalTrials.gov