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

Not Applicable

Not yet recruiting

• Conditions: Antibiotic Side Effect
• Interventions: Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levels

• Registration Number: NCT06395454
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-04-30
• Status Verified: 2024-05
• Study First Posted: 2024-05-02
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Study Start: 2024-07-01
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin guided antibiotics treatment duration	Shorten antibiotics duration based on procalcitonin test levels	Procalcitonin test in addition to standard care blood investigations

Primary Outcome Measures

Name	Time	Method
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic	14 days	compare the duration of antibiotics between 2 arms
To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic	14 days	compare the length of ICU stay in between 2 arms

Secondary Outcome Measures

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