The efficacy of Rifapentine plus Moxifloxacin against Onchocercia-sis.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201608001754356
• Date of registration: 26/08/2016
• Prospective Registration: Yes
• Primary sponsor: Kumasi Centre for Collaborative Research into Tropical Medicine
• Public title: The efficacy of Rifapentine plus Moxifloxacin against Onchocercia-sis.
• Scientific title: The efficacy of Rifapentine 900mg/d plus Moxifloxacin 400mg/d given for 14 or 7 days against Onchocerciasis ¿ a randomized, controlled, parallel-group, open-label, phase II pilot trial.
• Date of first enrolment: 01/12/2016
• Target sample size: 80
• Recruitment status: Pending
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1754
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Randomization to the treatment groups will be conducted by central randomization. Randomization is car-ried out according to a predefined randomization list provided by the Institute for Medical Biometry, In-formatics and Epidemiology (IMBIE), University of Bonn.,All persons involved in data handling and the statistical analyses at the end of the trial as well as the histo-logical outcome assessors will stay blinded to the nature of the treatment. After randomization the treat-ment can be initiated according to the treatment code.
• Phase: Phase-2

Countries of recruitment

Ghana

Contacts

• Name: Alexander Yaw Debrah
• Affiliation: Dean of faculty,KNUST

• Name: Linda Batsa Debrah
• Affiliation: Lecturer, School of Medical Sciences, KNUST

Key inclusion & exclusion criteria

Inclusion criteria: ¿Willingness to participate in the study by signing the Informed Consent Form (ICF)
¿18-55 years
¿Body weight > 45kg
¿Presence of at least 1 medium-sized onchocercoma detected by palpation Mf-positive
¿Good general health without any clinical condition requiring medication
¿No previous history of tuberculosis
¿Participants with the ability to follow study instructions and are likely to attend and complete all re-quired visits

Exclusion criteria: ¿Participants not able to give consent
¿Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
¿Participants taking any concomitant medication
¿Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical struc-ture (moxifloxacin or any member from the quinolone class, rifapentine or any member of the ri-famycins, doxycycline or any member of the tetracyclines)
¿Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
¿Participants with a physical or psychiatric condition which at the investigator¿s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject¿s participation in this clinical trial
¿Known or persistent abuse of medication, drugs or alcohol
¿Pregnant women
¿Breastfeeding women
¿Females of childbearing potential, who are not willing or able to use methods to prevent a pregnancy for the entire treatment duration in addition to hormonal contraception (e.g. condoms) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
¿History or clinical signs of tuberculosis or treatment against TB
¿History of porphyria
¿History or clinical signs of arrhythmia
¿Bradycardia (< 50bpm)
¿QT-prolongation (QT interval >440 msec for men and >460 msec for women)
¿History of tendinitis or tendon rupture
¿History of rheumatoid arthritis
¿History of myasthenia gravis or polio
¿History of cerebral disorder (e.g. epilepsy)
¿History of photosensitivity/phototoxicity
¿History of Diabetes mellitus (in addition urine examination for glucose)
¿Evidence of clinically significant neurological, cardiac, pulmonary, hepatic or renal disease as far as can be assessed by history of participants, physical examination, and/or laborato

Age minimum: 18 Year(s)
Age maximum: 55 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Onchocerciasis

Onchocerciasis

Intervention(s)

Doxycycline

Nodulectomy only

Rifapentine plus Moxifloxacin

Primary Outcome(s)

Absence of Wolbachia endobacteria in adult worms assessed by immuno-histology

Secondary ID(s)

IMMIP-201401

Source(s) of Monetary Support

Kumasi Centre for Collaborative Research into Tropical Medicine

Ethics review

Status: Not approved
Approval date:
Contact:

Committee on Human Research,Publication and Ethics