Research Title: Efficacy and Safety of Point- Of-care Procalcitonin Test to Reduce Antibiotic Exposure in VAP

NCT03982667 | Completed DMC

• 1 other identifier: USMalaysia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Several studies have shown that PCT guidance can reduce the duration of antibiotic treatment for patients with bacterial infections in the ICU, without compromising the safety outcomes. However PCT is known to be more costly than standard biomarkers that commonly use in our ICU setup. This remain the main challenge for us whether by monitoring the PCT level, it can reduce both the duration of antibiotic simultaneously reduce the total cost of the treatment for the patients. A local study addressing efficacy, safety and cost analysis of PCT-guided antibiotic therapy in severe pneumonia patients is therefore warranted. Until the results from a local study become available, the utility of PCT to guide antibiotic duration in our patient population cannot be recommended.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• To compare the duration of antibiotic treatment between PCT and standard of care groups

  Most of the antiobiotic duration is about 5 - 14 days. In Ventilated Associated Pneumonia, the duration of antibiotic treatment is difficult to stop since the patient stil in intensive care unit due to multiple factors. Therefore the use of PCT guided might be useful.

  3 to 14 days

Secondary Outcomes (2)

• To compare the mortality between PCT and standard of care

  30 days

• To compare the rate of recurrence infection between PCT and standard of care

  30 days

Study Arms (2)

PCT group

EXPERIMENTAL

For patients randomly assigned to the PCT-guided group, measurements of serum PCT concentrations (Day 1, 3, 7, and 9) will be taken and made available to the attending physicians. This means 3 ml of whole blood will be sampled from the arterial line of the patients for each measurement the serum PCT in plain tubes. The samples will be immediately assayed for the PCT measurement using the available device and the results will be ready in next 30 minutes after running the system.

Diagnostic Test: PCT-guided group

Standard-of-care group

NO INTERVENTION

Interventions

PCT-guided group DIAGNOSTIC_TEST

In the PCT-guided group, the study protocol encourages to stop the prescribed antibiotics if PCT concentration decrease by 80% or more of its peak value (or if PCT concentration is ≥0·25 and \<0·5 μg/L), and strongly encourage to stop the prescribed antibiotics when it reaches a value of \< 0·25 μg/L. The attending physician is free to decide whether to continue antibiotic treatment in patients who reach these thresholds. Reasons for non-adherence will be recorded. Antibiotics in the standard-of-care group will be stopped according to local or national guidelines and according to the discretion of attending physicians. Patients will be followed-up until hospital discharge.

PCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above; and
• Admitted to the ICU; and
• Treated as Ventilator Associated Pneumonia (VAP)

You may not qualify if:

• Systemic antibiotics as prophylaxis only
• Antibiotics solely as part of selective decontamination of the digestive tract
• Prolonged therapy (eg, endocarditis)
• Expected ICU stay of less than 24 h
• Severe immunosuppression
• Severe infections due to non-bacterial causes
• Previously been enrolled in the study

Sponsors & Collaborators

• Mohd Zulfakar Mazlan, MBBS: lead

Study Sites (2)

Mohd Zulfakar Mazlan, MBBS

Kota Bharu, Kelantan, 16150, Malaysia

Location

Mohd Zulfakar Mazlan

Kota Bharu, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: June 11, 2019
• Study Start: June 15, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (2)