Actively Recruiting
Leptospirosis Care Bundle Study: A Randomized Controlled Trial
Led by Chulalongkorn University · Updated on 2025-08-07
300
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach called the Leptospirosis Care Bundle for patients with Leptospirosis, a condition that can lead to complications like acute kidney injury. The study acknowledges the importance of finding effective management strategies for this illness. The Care Bundle has shown promise in reducing the risk of acute renal failure in affected patients. The treatment involves a step-by-step process including identifying suspected Leptospirosis cases, conducting investigations, administering antibiotics within one hour after blood cultures are taken, providing intravenous fluids, and managing acute kidney injury based on disease stage using KDIGO guidelines. Participants are randomly assigned to either receive this Care Bundle or no intervention as a control group. During the study, participants will be closely monitored for kidney function, with the primary outcome being the number of patients who experience reduced acute kidney injury within 72 hours. Hospitalized patients will be assessed through clinical signs and laboratory tests. The study is sponsored by Chulalongkorn University and participation involves regular evaluations during the hospital stay until the primary outcome is measured.
CONDITIONS
Brief Title
Leptospirosis Care Bundle Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Suspicious Leptospirosis including body temperature over 38 Celsius, severe myalgia, and exposure to reservoir hospital or flood water
- Calf muscle tenderness
- Conjunctival suffusion
- Anuria or oliguria and/or proteinuria
- Jaundice
- Hemorrhagic manifestations such as pulmonary and intestinal bleeding
- Meningeal irritation
- Nausea, vomiting, abdominal pain, or diarrhea
- Admitted in hospital
You will not qualify if you...
- Other infectious disease
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 hours
Participants receive a step-by-step care bundle including suspected case identification, investigations, timely antibiotics, intravenous fluids, and stage-based management of acute kidney injury.
Participants are treated continuously during hospitalization
Trial Site Locations
Total: 1 location
1
Chulalongkorn university
Bangkok, Bangkok, Thailand, 10330
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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