Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection

January 16, 2012 updated by: Brahms AG

ProBac - Use of Procalcitonin Level as Part of a Decision Tree to Discontinue Antibiotics When Started Empirically in the ICU in Hemodynamically Stable Patients With no Site of Infection Identified

The purpose of this study is to test whether a U.S. Food and Drug Administration (FDA) approved laboratory test (PCT Kryptor) can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study is undertaken as prospective, randomized, controlled, multicenter trial. The study population, ICU patients with empiric antibiotic treatment due to suspected but unproven infection, is randomly assigned to either a Standard Care Group or a Procalcitonin (PCT) Guided Group. In the standard care group, antibiotic treatment would be based totally on clinical decision making with "traditional thought processes" (i.e., cultures, response to antibiotics, risk of untreated infection, other laboratory findings, etc.). The PCT guided group will use the same "traditional thought processes" and in addition the physician will be given access to a PCT value for Day 1 and Day 4 along with the recommended thresholds for likelihood of infection. In conjunction with other laboratory findings and clinical assessments the threshold of PCT is used to continue or discontinue empiric antibiotic treatment.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Saint Louis University - medical intensive care unit
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspected infection (no clear-cut source of infection) as defined by the treating physician
  • Empiric antibiotic treatment
  • No clear-cut source of infection by clinical or microbiological criteria
  • ICU patient
  • Informed consent

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • Hemodynamic instability defined as persistent hypotension, need for on-going aggressive resuscitation and/or vasopressor support to maintain an adequate mean arterial blood pressure
  • Need for antibiotic prophylaxis
  • Patient withdrawn from empiric antibiotic treatment before Day 4
  • Severely immuno-compromised patient (liver cirrhosis (Child-Pugh class C), immunosuppressive drugs after transplantation, neutropenia (absolute neutrophil count <1000 counts/L), CD-4 count less than 200)
  • Patient with suspected bacterial or fungal endocarditis
  • Patient with suspected meningitis
  • Cardiopulmonary bypass within the last 7 days1)
  • Major surgery within the last 7 days (surgery that induces a major inflammatory response such as heart or aortic surgery or major abdominal surgery (i.e. duodenopancreatectomy) or any surgery requiring massive blood transfusion.)
  • Multiple trauma within the last 7 days
  • Cardiopulmonary resuscitation (CPR) within the last 7 days
  • Burns >20% body surface area
  • Patient in terminal status referred for palliative care
  • Patient with advanced directives or Do Not Resuscitate (DNR) orders
  • Patient who is already enrolled in another therapeutic clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment
Experimental: PCT
PCT guided arm
Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor
antibiotic treatment based on clinical decision making with "traditional thought processes" used in both groups. In addition the physician will be given access to Procalcitonin values with recommended thresholds for likelihood of infection.
Other Names:
  • B.R.A.H.M.S, Kryptor, Procalcitonin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up)
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Days on antibiotics during ICU stay
Time Frame: up to 28 days
up to 28 days
Sepsis classification
Time Frame: up to 28 days
up to 28 days
SOFA score (modified)
Time Frame: up to 28 days
up to 28 days
ICU or hospital mortality up to 28 days
Time Frame: up to 28 days
up to 28 days
Frequency of infections
Time Frame: up to 28 days
up to 28 days
ICU and hospital length of stay
Time Frame: up to 28 days
up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brahms AG

Investigators

  • Study Chair: Phil Dellinger, M.D., The Cooper Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

December 4, 2006

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProBac

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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