Leptospirosis Care Bundle Study
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2022
CompletedFirst Submitted
Initial submission to the registry
June 10, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedAugust 7, 2025
August 1, 2025
2.3 years
June 10, 2022
August 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Care Bundle Group
EXPERIMENTALTreatment 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)
Control Group
NO INTERVENTIONInterventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- other infectious disease
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chulalongkorn university
Bangkok, Bangkok, 10330, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Dr.Nattachai Srisawat
Study Record Dates
First Submitted
June 10, 2022
First Posted
June 21, 2022
Study Start
October 1, 2019
Primary Completion
January 19, 2022
Study Completion (Estimated)
December 31, 2026
Last Updated
August 7, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share