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Leptospirosis Care Bundle Study

Leptospirosis Care Bundle Study: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05425524
Enrollment
300
Registered
2022-06-21
Start date
2019-10-01
Completion date
2026-12-31
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis

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.

Interventions

PROCEDURECare 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)

Sponsors

Chulalongkorn University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Reduce AKI in 72 hours72 hoursTo 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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026