Evaluation of the impact of large scale, community directed delivery of doxycycline for the treatment of onchocerciasis

Phase 3

Completed

Conditions: Onchocerciasis (Onchocerca volvulus)
Infections and Infestations
Onchocerciasis

Registration Number: ISRCTN95189962

Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 682

Inclusion Criteria

Stage 1
1. Participants of both sexes aged 19 years or above
2. Received either 6 weeks of doxycycline MDA followed by one or two rounds of annual ivermectin MDA or one or two rounds of annual ivermectin MDA alone
3. Willingness to participate in the study by signing the informed consent form

Stage 2
1. Participants of both sexes aged 19 years or above
2. Received either 6 weeks of doxycycline MDA followed by one or two rounds of annual ivermectin MDA or one or two rounds of annual ivermectin MDA alone
3. Presence of a minimum of one onchocercoma detected by palpation
4. Good general health without any clinical condition under treatment with long term medication
5. Willingness to participate in the study by signing the informed consent form

Exclusion Criteria

For stages 1 and 2:
1. Ivermectin intake since June 2010 (date of last ivermectin MDA)
2. Intake of antibiotics (tetracyclines or rifamycins) for longer that 2 weeks since June 2007
3. Behavioural, cognitive or psychiatric diseases that in the opinion of the trial clinician affects the ability of the participant to understand and cooperate with the study protocol
4. Any other condition that, in the opinion of the investigator (trial clinician), would risk the safety or rights of the participants 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
To evaluate the efficacy of doxycycline MDA followed by ivermectin MDA four years after delivery, at the community level (Stage 1) and known infected patients (Stage 2) and validate compliance rate of phase III implementation trial

Secondary Outcome Measures

Name	Time	Method
To evaluate whether ultrasonograpy of palpable nodules to detect parasite motility can be used to monitor and evaluate macrofilaricidal activity after doxycycline MDA