Leptospirosis care bundle to reduce acute kidney failure
Leptospirosis Care Bundle Study: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT05425524 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bangkok, Bangkok
- Chulalongkorn university — Bangkok, Bangkok, Thailand (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.