Leptospirosis care bundle to reduce acute kidney failure
Official title: Leptospirosis Care Bundle Study: A Randomized Controlled Trial
Run by Chulalongkorn University · NCT05425524 · Data updated 2026-11-12
This will try a care bundle to see if it reduces the chance of acute kidney failure in adults admitted to hospital with suspected leptospirosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Status | Recruiting |
| Started | October 1, 2019 |
| Main results expected | January 19, 2022 |
| Study ends | December 31, 2026 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT05425524 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 hospitalized with suspected leptospirosis who show clinical signs such as fever, severe myalgia, calf tenderness, conjunctival suffusion, jaundice, oliguria/proteinuria, hemorrhagic or meningeal features, and who are not pregnant or diagnosed with another infection.
✕Probably not a fit
Patients with other confirmed infectious diseases, pregnant patients, those managed entirely as outpatients, or those with already irreversible organ failure may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults admitted with suspected leptospirosis at Chulalongkorn University Hospital receive a standardized Leptospirosis Care Bundle that codifies monitoring and early management steps aimed at preventing organ dysfunction. Eligible patients meet clinical criteria such as fever, severe myalgia, calf tenderness, conjunctival suffusion, jaundice, oliguria/proteinuria, or hemorrhagic or meningeal signs, while pregnant patients and those with other infectious diseases are excluded. The intervention is delivered during hospitalization and outcomes focus on incidence of acute kidney injury and related clinical endpoints. The protocol is implemented at a single center in Bangkok with predefined clinical entry criteria and in-hospital follow-up.
Why it matters
Potential benefit: If successful, the care bundle could reduce acute kidney injury and related complications in hospitalized leptospirosis patients.
How similar studies have gone: Care-bundle and early-supportive management approaches for leptospirosis have shown promise in reducing acute renal failure in prior reports, but robust, generalizable evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years * Suspicious Leptospirosis including body temperature \> 38 celcius, Severe myalgia, and exposure to reservoir hospital of flood water. * Calf muscle tenderness * Conjunctival suffusion * Anuria or oliguria and/or proteinuria * Jaundice * Hemorrhagic manifestations (pulmonary and intestine) * Meningeal irritation * Nausea, vomiting, abdominal pain, diarrhea. * Admitted in hospital Exclusion Criteria: * other infectious disease * pregnancy
Where it's running
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Chulalongkorn university
Bangkok, Bangkok, Thailand Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.