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

Primary Purpose

Sepsis, Intensive Care

Status

Withdrawn

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Procalcitonin measurement

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Biomarkers, Antibiotic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alysis Zorggroep, Rijnstate Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PCT guided antibiotic therapy

Standard antibiotic therapy

Arm Description

Outcomes

Primary Outcome Measures

duration of antibiotic therapy

Secondary Outcome Measures

28 day mortality

Full Information

NCT ID

NCT00987818

First Posted

September 16, 2009

Last Updated

August 31, 2015

Sponsor

Rijnstate Hospital

Collaborators

Stichting Vrienden van het Alysis Leerhuis

1. Study Identification

Unique Protocol Identification Number

NCT00987818

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Why Stopped

No MEC approval

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Rijnstate Hospital

Collaborators

Stichting Vrienden van het Alysis Leerhuis

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis, Intensive Care

Keywords

Biomarkers, Antibiotic therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PCT guided antibiotic therapy

Arm Type

Experimental

Arm Title

Standard antibiotic therapy

Arm Type

Placebo Comparator

Intervention Type

Other

Intervention Name(s)

Procalcitonin measurement

Intervention Description

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

Primary Outcome Measure Information:

Title

duration of antibiotic therapy

Time Frame

28 days

Secondary Outcome Measure Information:

Title

28 day mortality

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Alysis Zorggroep, Rijnstate Hospital

City

Arnhem

State/Province

Gelderland

ZIP/Postal Code

6800TA

Country

Netherlands

12. IPD Sharing Statement

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

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