Usage of Procalcitonin to Reduce Antibiotics Duration in VAP in Neurosurgical ICU

May 31, 2024 updated by: Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia

Procalcitonin as a Sepsis Biomarker in Guiding Antibiotics Treatment Duration in Ventilator Associated Pneumonia in Neuro-ICU: A Randomised Controlled Trial

Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who are more than 18 years old who are admitted to Neurosurgical ICU will be recruited 48hours after ventilation if matches criteria for ventilator associated pneumonia. Patients will be randomised into 2 groups. first group will be procalcitonin guided in addition to conventionally guided sepsis assessment (TWC, CRP, body temperature). second group is only conventionally guided sepsis assessment. in procalcitonin guided group, blood sample will be taken on Day 1 of recruitment and day 5. On day 5 , the procalcitonin level will be compared to recommendations in PRORATA trial. If procalcitonin level is below the level to withhold antibiotics, recommendation will be made to the primary physician to off the antibiotics. Another Procalcitonin level will be repeated on Day 7 to rule out reinfection. This study aims to compare the duration of antibiotics and length of ICU stay among the 2 groups.

This study will fill up the gap among the lack of datas in neurosurgical patients.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients admitted to Neuro-ICU & Trauma ICU
  • Patients aged >18 years old.
  • Ventilation for >48 hours
  • VAP and treated with antibiotics <24hours prior to inclusion in trial.
  • Patient with arterial line or central line

Exclusion Criteria:

  • Patients who are on antibiotics but not assumed or proven to have VAP
  • Expected short ICU stay (<3 Days)
  • Non-bacterial infections
  • Long term antibiotic treatment (transplant or chemotherapy patients, endocarditis, osteomyelitis)
  • Hospitalisation 48hours before enrolment
  • Severe immunosuppression
  • Pregnancy
  • Primary team's decision to continue antibiotics for 14 days prior to trial
  • DNAR or expected to die within 5 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Procalcitonin guided antibiotics treatment duration
Procalcitonin test in addition to standard care blood investigations
Diagnostic test: Shorten antibiotics duration based on procalcitonin test levels
procalcitonin test will be taken on day 1 of recruitment as baseline, test done on day 5 will decide whether antibiotics will be withheld, followed by day 7 to determine rate of reinfection.
No Intervention: Standard care guided antibiotics treatment duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
Time Frame: 14 days
compare the duration of antibiotics between 2 arms
14 days
To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic
Time Frame: 14 days
compare the length of ICU stay in between 2 arms
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare 14 days mortality rate in between 2 arms
Time Frame: 14 days
compare 14 days mortality rate in between 2 arms
14 days
To compare proportion of difficult to treat organisms (MRO) in between 2 arms
Time Frame: 14 days
compare proportion of difficult to treat organisms (MRO) in between 2 arms
14 days
To compare the proportion of reinfection within 72 hours after stopping antibiotics
Time Frame: 14 days
compare the proportion of reinfection within 72 hours after stopping antibiotics
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Zulfakar Mazlan, Associated Professor Dr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/KK/24010018

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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