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

Not Applicable

• Conditions: Bacterial infections

• Registration Number: PACTR201909715467725
• Lead Sponsor: Rispah Chomba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-04
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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