Procalcitonin-guided antibiotic therapy for suspected and confirmed sepsis of patients in a surgical-trauma ICU: a prospective, two-period cross-over, interventional study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201909715467725

Enrollment

Registered

2019-09-20

Start date

2014-04-01

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

Bacterial infections

Interventions

Control group

Procalcitonin group

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over the age of 18 years admitted to the trauma ICU with suspected or confirmed bacterial sepsis with written consent and who survived more than 48 hours after study inclusion.

Exclusion criteria

Exclusion criteria: Patients in whom consent could not be obtained Patients with severe co-morbidities e.g. congestive cardiac failure, cirrhosis, insulin dependent diabetes, chronic renal failure requiring dialysis, pregnancy and advanced HIV infection with CD4 ?100 cells/µL. Patients requiring prolonged antibiotic therapy e.g. Clostridium difficile, Listeria monocytogenes, tuberculosis, fungal sepsis, osteomyelitis, lung abscess and sepsis involving a prosthetic device that could not be removed Patients who had received antibiotics for more than 48 hours before enrollment Patients with poor chance of survival (ISS score =45, injury critical or untreatable at screening).

Design outcomes

Primary

Measure	Time frame
1)Duration of antibiotic treatment for every sepsis episode until 28 days after study inclusion. 2)Clinical outcomes: a.Antibiotic free days alive at 28 days from study inclusion. b.28 day hospital mortality (death from any cause). c.ICU length of stay. d.Recurrence or relapse of infection	—

Secondary

Measure	Time frame
1) Sources of sepsis as per positive microbiology cultures from clinical specimens with clinical correlation. 2) Bacterial species isolated from clinical specimens and susceptibility profiles. 3) Emergence of multidrug resistant bacteria in the two groups. 4) Profile of procalcitonin concentrations in septic trauma patients. 5) Compliance with procalcitonin study algorithm 6) Clinical outcomes of patients in who study algorithm was over-ruled.	—

Measure

Time frame

1) Sources of sepsis as per positive microbiology cultures from clinical specimens with clinical correlation. 2) Bacterial species isolated from clinical specimens and susceptibility profiles. 3) Emergence of multidrug resistant bacteria in the two groups. 4) Profile of procalcitonin concentrations in septic trauma patients. 5) Compliance with procalcitonin study algorithm 6) Clinical outcomes of patients in who study algorithm was over-ruled.

—

Countries

South Africa

Contacts

Public ContactSteve Moeng

Trauma surgeon

drmoeng.trauma@gmail.com+27828878621

Outcome results

None listed

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