Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Not Applicable

Withdrawn

• Conditions: Intensive Care; Sepsis
• Interventions: Other: Procalcitonin measurement

• Registration Number: NCT00987818
• Lead Sponsor: Rijnstate Hospital

Brief Summary

The adequacy of early empiric antimicrobial therapy is an important factor in determining the outcome in patients with severe sepsis. The duration of adequate antibiotic therapy in these patients however is less clear. Duration of antibiotic therapy in patients with sepsis in the ICU based on inflammatory markers has not been extensively studied.

Procalcitonin (PCT) is an acute phase protein that has prognostic value in critically ill patients and can be used to monitor disease activity in sepsis and systemic inflammation. This study will examine the effect of PCT guided antibiotic therapy compared with conventional antibiotic therapy on treatment duration in patients with sepsis admitted to the ICU.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Status Verified: 2012-12
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients admitted to the ICU
• Age > 18 years
• Antibiotic therapy for sepsis with a suspected or proven focus of infection

Exclusion Criteria

• Age < 18 years
• Pregnancy
• Infection or presumed infection requiring prolonged antibiotic therapy (osteomyelitis, meningitis, endocarditis, septic arthritis, mediastinitis, tuberculosis, Pneumocystis jiroveci pneumonia, Toxoplasmosis, Legionellosis, Listeriosis)
• Indication for prolonged systemic prophylactic antibiotic therapy
• Severe viral or parasitic infections (hemorrhagic fever, malaria)
• Antibiotic therapy started 48 hours before enrollment
• Severe immunocompromised patients (AIDS with a CD4 count < 200cells/mm3, severe neutropenia(<500 neutrophils/mm3), patients undergoing immunosuppressive therapy after solid organ transplantation)
• Patients foregoing life sustaining treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCT guided antibiotic therapy	Procalcitonin measurement	-
Standard antibiotic therapy	Procalcitonin measurement	-

Primary Outcome Measures

Name	Time	Method
duration of antibiotic therapy	28 days

Secondary Outcome Measures

Name	Time	Method
28 day mortality	28 days

Trial Locations

Locations (1)

Alysis Zorggroep, Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands