Onchocerciasis
Conditions
Interventions
Rifapentine plus Moxifloxacin
Doxycycline
Nodulectomy only
Sponsors
Kumasi Centre for Collaborative Research into Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion 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
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 (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of Wolbachia endobacteria in adult worms assessed by immuno-histology | — |
Countries
Ghana
Contacts
Public ContactLinda Batsa Debrah
Lecturer, School of Medical Sciences, KNUST
Outcome results
None listed