Leptospirosis Care Bundle Study

Leptospirosis Care Bundle Study: A Randomized Controlled Trial

So in management of Leptospirosis patients There really is no another approach to treatment. The importance of the problem was acknowledged by the researchers. As a result, this study was performed in order to The Leptospirosis Care Bundle has been used, and has been proved that its use can reduce the risk of acute renal failure.

Study Overview

• Status: Recruiting
• Conditions: Leptospirosis
• Intervention / Treatment: Procedure: Care Bundle

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Chulalongkorn University
    • Contact: Nattachai Srisawat, MD; Phone Number: 3597 6622564000; Email: drnattachai@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Care Bundle Group; Treatment step by step we have 5 steps STEP 1: Leptospirosis suspected case STEP 2: Investigations STEP 3: Antibiotics within 1 hour after Hemocultures were taken STEP 4: Intravenous Fluid STEP 5: Stage-Base Management of AKI (KDIGO)	Procedure: Care Bundle; Treatment step by step we have 5 steps STEP 1: Leptospirosis suspected case STEP 2: Investigations STEP 3: Antibiotics within 1 hour after Hemocultures were taken STEP 4: Intravenous Fluid STEP 5: Stage-Base Management of AKI (KDIGO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Reduce AKI in 72 hours	To see if using care bundle for leptospirosis patients can improve reduce the incidence of acute renal failure in the first 72 hours of being admitted to hospital.It classified AKI into three categories (risk, injury, and failure) according to the status of serum creatinine (SCr) and urine output (UO) by AKIN/KDIGO	72 hours

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 19, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: IRB.521/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No