Clinical trial NCT06395454: Usage of Procalcitonin to Reduce Antibiotics Duration in VAP in Neurosurgical ICU
Official title: Procalcitonin as a Sepsis Biomarker in Guiding Antibiotics Treatment Duration in Ventilator Associated Pneumonia in Neuro-ICU: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Antibiotic Side Effect
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In a parallel group design, participants are randomized to two groups (PCT guided versus Non PCT guided (standard of care).

Each group receives a different intervention (e.g., pct vs crp, tw, blood culture, temperature and clinical).

The groups are compared to assess the effectiveness of the interventions.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
timeFrame: 14 days
measure: To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic
timeFrame: 14 days
Secondary outcomes:
measure: To compare 14 days mortality rate in between 2 arms
timeFrame: 14 days
measure: To compare proportion of difficult to treat organisms (MRO) in between 2 arms
timeFrame: 14 days
measure: To compare the proportion of reinfection within 72 hours after stopping antibiotics
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Associated Professor Dr
name: Zulfakar Mazlan
role: PRINCIPAL_INVESTIGATOR
References:
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