The efficacy of rifapentine plus moxifloxacin against onchocerciasis: a randomized, open label pilot trial.

Phase 2

Recruiting

• Conditions: Onchocerciasis (River blindness); Infections and Infestations

• Registration Number: ISRCTN43697583
• Lead Sponsor: Kumasi Centre for Collaborative Research (KCCR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-17
• Last Update Posted: 14 January 2019
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Participant inclusion criteria as of 05/12/2018:
1. Willingness to participate in the study by signing the Informed Consent Form (ICF)
2. 18-55 years
3. Body weight > 45kg
4. Presence of at least 1 medium-sized onchocercoma detected by palpation
5. Mf-positive
6. Good general health without any clinical condition requiring medication
7. No previous history of tuberculosis
8. Participants with the ability to follow study instructions and are likely to attend and complete all required visits

Previous participant inclusion criteria:
1. Men and Women
2. 18-55 years
3. Body weight > 45kg
4. Presence of at least 3 onchocercomata detected by palpation
5. Mf-positive
6. Good general health without any clinical condition requiring long-term medication
7. No previous history of tuberculosis
8. Participants with the ability to follow study instructions and are likely to attend and complete all required visits
9. Willingness to participate in the study by signing the Informed Consent Form (ICF)

Exclusion Criteria

Participant exclusion criteria as of 05/12/2018:
General Exclusion Criteria:
1. Participants not able to give consent
2. Participants who are unable to understand the nature, scope, significance and consequences of this clinical trial
3. Participants taking any concomitant medication
4. 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 rifamycins, doxycycline or any member of the tetracyclines)
5. Simultaneous participation in any clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning
6. 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
7. Known or persistent abuse of medication, drugs or alcohol

Exclusion criteria regarding special restrictions for females:
1. Pregnant women
2. Breastfeeding women
3. 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.

Indication specific exclusion criteria:
1. History or clinical signs of tuberculosis or treatment against TB
2. History of porphyria
3. History or clinical signs of arrhythmia
4. Bradycardia (< 50bpm)
5. QT-prolongation (QT interval >440 msec for men and >460 msec for women)
6. History of tendinitis or tendon rupture
7. History of rheumatoid arthritis
8. History of myasthenia gravis or polio
9. History of cerebral disorder (e.g. epilepsy)
10. History of photosensitivity/phototoxicity
11. History of Diabetes mellitus (in addition urine examination for glucose)
12. 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 laboratory examinations
13. Evidence of acute Hepatitis A and of acute or chronic Hepatitis B or C
14. Laboratory evidence of liver disease (AST, ALT, gammaGT, Bilirubin greater than the upper limit of normal)
15. Laboratory evidence of renal disease (serum creatinine greater than 1.5 times upper limit of normal)
16. Laboratory evidence of low or high potassium level (potassium level < 3.6 or > 5.2)
17. Laboratory evidence of leucopenia (< lower limit of normal)

Previous participant exclusion criteria:
1. Pregnant women
2. Breastfeeding women
3. Participants not able to give consent
4. Participants without legal capacity who are unable to understand the nature, scope, significance and consequences of this

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Primary outcome measure as of 05/12/2018:<br> Absence of Wolbachia endobacteria in female adult worms assessed by immunohistology 6 months after treatment onset.<br><br> Previous primary outcome measure:<br> Absence of Wolbachia endobacteria in adult worms assessed by immuno-histology 6 months after treatment onset.<br>