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Serum procalcitonin for ventilator-associated pneumonia

Procalcitonin-guided Discontinuation of Antibiotic in Ventilator-Associated Pneumonia

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20160726002
Enrollment
Unknown
Registered
2016-07-26
Start date
2012-12-25
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia ventilator&#45

Interventions

serum PCT level was first assessed after the enrolled patients received appropriate antibiotic for 7 days (day 8)&#44
revealed favorable clinical response within 7 days of appropriate antibiotic treatment including: body temperature < 37.8°C
without shock or use of inotropes or vasopressors and Clinical pulmonary infection score < 6. In the PCT group&#44
If PCT was less than 0.5 ng/mL&#44
antibiotics had to be discontinued. If PCT was 0.5 ng/mL or more&#44
antibiotics were to be continue and PCT level was reassessed two days later. If PCT was less than 0.5 ng/mL&#44
antibiotics were discontinued. If PCT was 0.5 ng/mL or more&#44
antibiotics were continued for 14 days. ,In the conventional group&#44
serum PCT level was assessed once. However&#44
the treating physicians were not informed the result of this serum PCT and antibiotics discontinuation would be determined according to the treating physicians discretion.
Experimental Behavioral,No Intervention Behavioral
PCT group,Conventional group

Sponsors

&#45;
Lead Sponsor
&#45
Collaborator
,&#45
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: &#45; Patients who were intubated and had received mechanical ventilation for at least 48 hours. &#45;age > 18 years &#45; clinical suspicion of VAP as defined by the ATS guidelines (new or progress pulmonary infiltration on CXR with two or more of the following: new or progress of fever; purulent sputum; WBC 12&#44;000 cell/mm3); and simplified version of clinical pulmonary infection score > 6.

Exclusion criteria

Exclusion criteria: &#45; pregnant &#45; enrolled in another trial &#45; had little chance of survival &#45; had neutropenia (leukocyte counts 1 month) &#45; had concomitant acquired immunodeficiency syndrome &#45; had a concomitant extrapulmonary infection diagnosed between days 1 and 3 that required prolonged (>8 days) antibiotic treatment or infection caused by confirmed non&#45;bacterial pathogens such as fungus or virus. &#45; not received appropriate antibiotic within 3 days after enrollment &#45; had unfavorable clinical response after 7 days of appropriate antibiotic treatment as defined by one of the following: body temperature >37.8°C; shock or use of inotropes or vasopressors; clinical pulmonary infection score >6.

Design outcomes

Primary

MeasureTime frame
Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment 28 &#45; Total antibiotic exposure days,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count,Number of antibiotic&#45;free days alive assessed 28 days after enrollment From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment count

Secondary

MeasureTime frame
relapse or superinfection rate&#44; From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment Patients were considered to have recurrent pneumonia when at least 1 bacterial species was reported ,number of mechanical ventilation&#45;free days From the day of enrollment (the day of diagnosis of VAP) to day 28 after enrollment 28 &#45; number of days without mechanical ventilation

Countries

Thailand

Contacts

Public ContactPHUNSUP WONGSURAKIAT

Siriraj Hospital&#44; Mahidol University

phunsup.won@mahidol.ac.th0892106692

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026