Comparison of doxycycline, minocycline, doxycycline plus albendazole and albendazole alone in their efficacy against onchocerciasis

Not Applicable

Completed

• Conditions: Onchocerciasis (Onchocerca volvulus); Infections and Infestations; Onchocerca volvulus infection

• Registration Number: ISRCTN06010453
• Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28056021 (added 18/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-20
• Study Completion: 2013-06-30
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Participants of both sexes, between 18-55 years old
2. Presence of at least one onchocercoma detected by palpation
3. Participation in the Mass Drug Administration (MDA) depending on microfilaria (Mf) status:
3.1. Mf-positive (> 10 mf/mg skin) or > 2 palpable onchocercomata: no limitation of ivermectin (MDA) rounds
3.2. Mf-positive (0.1 - 10 mf/mg skin) and = 2 palpable onchocercomata: last ivermectin treatment > 1 year ago and not more than three rounds
3.3. Mf-negative (0 mf/mg skin) = 2 palpable onchocercomata: last ivermectin treatment > 1 year ago and not more than one round
4. Good general health without any clinical condition requiring long-term medication
5. Body weight > 40 kg
6. Willingness to participate in the study by signing the Infomed Consent Form (ICF)

Exclusion Criteria

1. Known intolerance to the study drugs (doxycycline, minocycline, albendazole)
2. Pregnancy (pregnancy tests will be carried out pre-treatment and 14 days after treatment onset)
3. Breastfeeding
4. History of severe allergic reaction or anaphylaxis
5. Alcohol or drug abuse
6. 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 (as specified under 10 and 11)
7. Behavioural, cognitive or psychiatric disease that in the opinion of the trial clinician affects the ability of the participant to understand and cooperate with the study protocol
8. Severe asthma (emergency room visit or hospitalization)
9. Participation in other drug trials while this study is ongoing
10. Laboratory evidence of liver disease (ALT, µGT greater than 1.5 times the upper limit of normal results as stated by the manufacturer, CHEM7®; ALT: (0 ? 75 U/L), µGT: (females: 0 ? 69.5 U/L; males: 0 ? 80.7 U/L))
11. Laboratory evidence of renal disease (serum creatinine greater than 1.2 times the upper limit of normal results as stated by the manufacturer, CHEM7®; Crea: (0 ? 1.8 mg/dL))
12. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of a participant in the trial or would render the subject unable to comply with the protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 27/10/2014:<br> Absence of Wolbachia endobacteria in adult worms assessed by immunohistology<br><br> Previous primary outcome measures:<br> Reduction of Wolbachia endobacteria in adult worms assessed by immunohistology 6 months after treatment onset<br>