LeptospirosisPhase 4NCT07865156
These Studies That Evaluated the Efficacy of Antibiotics for Leptospirosis Treatment.
A Phase 4 study testing Doxycycline in people with Leptospirosis and Chemoprophylaxis, run by Chulalongkorn University.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Leptospirosis, Chemoprophylaxis
- What is being tested?
- Doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High-risk exposure typically refers to water or soil - particularly wet ground at workplace and/or contact with animal water reservoir
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sasipha Tachaboon Excellence center for critical care nephrology contact
About this study
Official title: The Study of the Efficacy of Doxycycline for Chemoprophylaxis Acute Leptospirosis Infection During Rainy Season in Thailand
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?
- Conditions
- Leptospirosis, Chemoprophylaxis
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Leptospirosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Doxycycline 200 mg weekly
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline 200 mg weekly dose | Experimental | Not described Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Leptospira infection
Number of leptospirosis cases based on Polymerase Chain Reaction (PCR), culture and Microscopic Agglutination Test (MAT)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeptospirosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865156
- Sponsor's protocol ID
- CREC087/68BR-MED30
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No