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

Sepsis Clinical Trial

Official title:

Reduction of Antibiotic Use in the ICU: Procalcitonin Guided Versus Conventional Antibiotic Therapy in Patients With Sepsis in the ICU

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00987818
• Other study ID #: 630-190809
• Status: Withdrawn
• Phase: N/A
• First received: September 16, 2009
• Last updated: August 31, 2015

Study information

• Verified date: December 2012
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intensive Care
• Sepsis

Intervention

Other:
• Procalcitonin measurement
Daily procalcitonin measurement. Antibiotic discontinuation policy dependent on procalcitonin value. In the control group standard duration of antibiotic therapy.

Locations

Country	Name	City	State
Netherlands	Alysis Zorggroep, Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Stichting Vrienden van het Alysis Leerhuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of antibiotic therapy		28 days	Yes
Secondary	28 day mortality		28 days	Yes