Study Title:
Doxycycline 200mg/d vs 100mg/d for 6 weeks to improve filarial lymphedema - a multinational,double blind,randomized,Placebo-controlled trial
Sponsor Name: National Institute for Malarial Research
Application Number: TFDA0017/CTR/0020, Date Received: 27/11/2017
Principal Investigator: Dr. Upendo Mwingira, National Institute for Medical Research, 3 Barack Obama Drive, P.O.Box 9653, 11101 Dar es Salaam
Intervention Medicinal Product Status of IMP
Doxycycline Unregistered
Primary Disease: Filariasis
Trial Site: 1)Sokoine Regional Referral Hospital P.O.Box 1011 Lindi 2)Tumbi regional Referral Hospital (TDRRH) P.O.Box 30041 Kibaha
Start / Approval Date: 28/06/2018, Status / Approval Remark: Approved
Primary Purpose: 1) Group A (LE stage 1-3) - To confirm the efficacy of a 6-weeks course of daily doxycycline 200 mg on lack of progression of filarial LE. 2) Group B (LE stage 4-6) - To show efficacy of a 6-week course of daily doxycycline 200 mg on lack progression of filarial LE.
Study Phase: Phase II
Study Type: Interventional
Expected Completion Date: 24th March, 2021
Target Sample Size: 420
Recruitment Status: Recruiting
Outcome: Lack of progression of LE (stage reduction or same stage as pre-treatment using the 7-point scale staging according to Dreyer[3]) examined 24 months after treatment onset.