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

U

Universiti Sains Malaysia

Status

Not yet enrolling

Conditions

Antibiotic Side Effect

Treatments

Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levels

Study type

Interventional

Funder types

Other

Identifiers

NCT06395454
USM/JEPeM/KK/24010018

Details and patient eligibility

About

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

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

Procalcitonin guided antibiotics treatment duration
Experimental group
Description:
Procalcitonin test in addition to standard care blood investigations
Treatment:
Diagnostic Test: Shorten antibiotics duration based on procalcitonin test levels
Standard care guided antibiotics treatment duration
No Intervention group

Trial contacts and locations

0

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Central trial contact

Jerome Loh

Data sourced from clinicaltrials.gov

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