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Not yet recruitingNCT07865156Updated Oct 8, 2026

These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.

A Phase 4 interventional study of Doxycycline and Placebo in Leptospirosis and Chemoprophylaxis, sponsored by Chulalongkorn University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Chulalongkorn University · Phase 4, Interventional, and Prevention

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this randomized controlled trial is to study antibiotic chemoprophylaxis to prevent leptospirosis of high-risk populations.

The main question it aims to answer is : Does the efficacy of chemoprophylaxis regimens to prevent prevent leptospirosis?

02

Conditions studied

  • Leptospirosis
  • Chemoprophylaxis

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03

In context

Leptospirosis

24 studies on the registry are indexed under Leptospirosis; 10 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 220 across 13 interventional studies indexed under Leptospirosis.

Browse Leptospirosis studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 313 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • High-risk exposure typically refers to water or soil - particularly wet ground at workplace and/or contact with animal water reservoir

Exclusion criteria

Exclusion Criteria:

  • Body temperature higher than 38 °C
  • Patients were confirmed to have leptospirosis within 3 months
  • Pregnancy or breastfeeding
  • Allergy to doxycycline
  • Cirrhosis Child-Pugh C, acute hepatitis, persistent elevated liver enzymes AST/ALT > 3 times
  • Doxycycline Interactions: phenytoin, carbamazepine, barbiturates, warfarin methotrexate, cyclosporin
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Doxycycline 200 mg weekly dose

    Drug: Doxycycline

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugDoxycycline

    Doxycycline 200 mg weekly

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Incidence of Leptospira infection

    Number of leptospirosis cases based on Polymerase Chain Reaction (PCR), culture and Microscopic Agglutination Test (MAT)

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07865156
Lead sponsor
Chulalongkorn University
Responsible party
Nattachai Srisawat ,M.D. (Principal investigator, Chulalongkorn University) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Oct 8, 2026

Study contacts

Sasipha Tachaboon Excellence center for critical care nephrology
Contact
sasipha.t@chulahospital.org
66635314464

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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