A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali

• Status: Completed
• Trial end date: 2020-12-19
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Task Force for Global Health
• Collaborator: United States Agency for International Development (USAID)
• Treatments: Doxycycline

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 they 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