Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05425524

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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