clinical trial azithromycin versus doxycycline chemoprophylaxis in leptospirosis in farmers
- Conditions
- leptospirosis.A27.8,A27.9
- Registration Number
- IRCT2015052322383N1
- Lead Sponsor
- Vice Chancellor for Research, Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 270
Inclusion criteria
All persons residing in endemic area of this disease and will supposed to work in the paddy field after taking a verified consent; All persons in the range of 18- 65 years old; Negative screening test for leptospirosis ; Agree to apply the doxycycline / azithromycin / placebo for all the times of paddy work ; Willing to regular monitoring for clinical manifestation; Willing to regular monitoring for three intermittent screening testing; Agree to report daily water contact; Agree to consult the related physician prior to taking any medication; No history of allergies to azithromycin or related compounds; No history of allergies to doxycycline or related compounds
Exclusion criteria:All persons who have positive first screening test for leptospirosis ;When the persons have hypersensitivity to azithromycin and doxycycline in history ; Pregnant women for doxycycline group; Severe adverse reaction for example; severe photosensitivity due to doxycycline;Severe adverse reaction to azithromycin;All persons who don’t agree to enroll in the research;All persons who don’t agree consent form
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fever,body pain,red eye,calf pain,icter. Timepoint: 0.6,12 week for IgG and 2nd week after developing disease for IgM. Method of measurement: questionnaire and ELISA.;Lab. data:thrombocytopenia.CPK,IgG,IgM. Timepoint: during the study, from beginning of prophylaxis and placebo, IgM Antileptospira checking 2-3 weeks after for participants will develop symptoms and IgG checking for all at zero,6 and 12 weeks. Method of measurement: questionnaire and ELISA.
- Secondary Outcome Measures
Name Time Method ausea,vomiting,esophagitis.photosensitivity. Timepoint: Drug consumption periods. Method of measurement: Interview.