Antibiotic Side Effect
Conditions
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.
Interventions
DIAGNOSTIC_TESTShorten 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.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| To compare 14 days mortality rate in between 2 arms | 14 days | compare 14 days mortality rate in between 2 arms |
| 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 |
| 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 |
Contacts
Primary ContactJerome Loh
Outcome results
None listed