Onchocerciasis (Onchocerca volvulus) Infections and Infestations Onchocerca volvulus infection
Conditions
Interventions
Treatment regimen 1 (n = 30): 4 weeks doxycycline 200 mg (2 capsules/day)
Treatment regimen 2 (n = 30): 3 weeks minocycline 200 mg (2 capsules/day)
Treatment regimen 3
Amansie Central and Adanse South Districts, Ashanti Region). The study drugs will be distributed personally by the research staff and drug intake be monitored on a daily basis for 3 days up to 4 weeks
Sponsors
Liverpool School of Tropical Medicine (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/10/2014: Absence of Wolbachia endobacteria in adult worms assessed by immunohistology Previous primary outcome measures: Reduction of Wolbachia endobacteria in adult worms assessed by immunohistology 6 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/10/2014: 1. Reduction of Wolbachia endobacteria in adult worms assessed by immunohistology 6 months after treatment onset 2. Reduction of Wolbachia endobacteria in adult worms assessed by PCR 3. Reduction of microfilariae in the skin (skin snips taken pre-treatment and after 6 as well as 23 months after treatment onset) 4. Absence of microfilariae in the skin (skin snips taken pre-treatment and after 6 as well as 23 months after treatment onset) 5. Evaluation of worm embryogenesis assessed by histology (6 months after treatment onset): 5.1. Normal embryos 5.2. Degenerated embryos 5.3. No embryos 6. Rates of nodules (onchocercomata) with microfilariae within the nodular tissue assessed by histology 7. Insemination of female worms assessed by histology 6 months after start of drug administration 8. Number of live/dead worms assessed by histology 9. Skin manifestation of the disease judged pre-treatment as well as 6 months after start of drug administration 10. Parasite-specific immunoglobulin subclasses and cytokine responses Previous secondary outcome measures: 1. Absence of Wolbachia endobacteria adult worms assessed by immunohistology 2. Reduction of Wolbachia endobacteria in adult worms assessed by PCR 3. Reduction of microfilariae in the skin (skin snips taken pre-treatment and after 6 months) 4. Absence of microfilariae in the skin (skin snips taken pre-treatment and after 6 months) 5. Evaluation of worm embryogenesis assessed by histology (6 months after treatment onset): 5.1. Normal embryos 5.2. Degenerated embryos 5.3. No embryos 6. Parasite-specific im | — |
Countries
Ghana
Outcome results
None listed