Study to assess efficacy of Doxycycline in Improving Filarial Lymphedema in India

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/08/009312
• Date of registration: 09-08-2017
• Prospective Registration: Yes
• Primary sponsor: Task Force for Global Health
• Public title: Study to assess efficacy of Doxycycline in Improving Filarial Lymphedema in India
• Scientific title: A Multi-center, Double-blind, Randomized, 24-month Study, to Compare the Efficacy of Doxycycline Once Daily for 6 Weeks Versus Placebo in Improving Filarial Lymphedema Independent of Active Filarial Infection - LeDoxy-India
• Date of first enrolment: 02-10-2017
• Target sample size: 750
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19416
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

India, Mali, Sri Lanka

Contacts

• Name: Suma Krishnasastry
• Affiliation: Govt T D Medical College

• Name: Suma Krishnasastry
• Affiliation: Govt T D Medical College

Key inclusion & exclusion 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: -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



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: B741- Filariasis due to Brugia malayi

Intervention(s)

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 Matching tablets without any ingredients
Placebo comparator: matching tablets containing no active ingredients
Intervention2: Doxycycline: Doxycycline 200mg per day x6 weeks for patients more than 50Kg body weight and 100mg for patients less than 50 mg body weight
Control Intervention1: Placebo: Look alike placebo tablets

Primary Outcome(s)

Improvement or halt of progression (Lack of progression) of lymphedema when examined 24 months after treatment onsetTimepoint: 24 months

Secondary Outcome(s)

-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

Secondary ID(s)

02929121

Source(s) of Monetary Support

The Task Force Global Health, 325 Swanton Way, Decatur, Atlanta, GA 30030, USA.

Ethics review

Status: Approved
Approval date: 27/12/2016
Contact:

Institutional Ethics Committee, T.D. Medical College, Alappuzha