Leptospirosis Care Bundle Study

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.

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Key information

Conditions

Leptospirosis Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Spirochaetales Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chulalongkorn university

Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Nattachai Srisawat, MD

CONTACT

[email protected]

6622564000 ext. 3597

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Care Bundle

Procedure

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)

Primary outcomes

Number of Participants with Reduce AKI in 72 hours

Time frame: 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Leptospirosis Care Bundle Study: A Randomized Controlled Trial

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2026
First posted: Jun 21, 2022
Registry last updated: Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting