clinical trial azithromycin versus doxycycline chemoprophylaxis in leptospirosis in farmers

A randomized double blind placebo-controlled trial: comparison of azithromycin with doxycycline prophylaxis against leptospirosis in human in an endemic area

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015052322383N1

Enrollment

270

Registered

2016-06-29

Start date

2015-05-25

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leptospirosis. A27.8,A27.9

Interventions

Intervention 1: intervention group 1 : will receive azithromycin 500mg weekly from 1 week before starting work, during and 4 weeks after that. Intervention 2: control group :will receive placebo( meth

Prevention

intervention group 1 : will receive azithromycin 500mg weekly from 1 week before starting work, during and 4 weeks after that.

control group :will receive placebo( methyl cellulose crystalline manufactured by Iran daru company)

intervention group 2: will receive doxycycline 200mg weekly from 1 week before starting work, during and 4 weeks after that.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Nausea,vomiting,esophagitis.photosensitivity. Timepoint: Drug consumption periods. Method of measurement: Interview.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zameni

Antimicrobial Resistance Research Center

pzameni3@yahoo.com+98 114221801820

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026