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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00407147
Recruitment Status : Terminated (termination due to futility (very slow patient enrollment))
First Posted : December 4, 2006
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Brahms AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infection Bacterial Infection Sepsis Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: B.R.A.H.M.S, Kryptor, Procalcitonin

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

Secondary Outcome Measures :
  1. Days on antibiotics during ICU stay [ Time Frame: up to 28 days ]
  2. Sepsis classification [ Time Frame: up to 28 days ]
  3. SOFA score (modified) [ Time Frame: up to 28 days ]
  4. ICU or hospital mortality up to 28 days [ Time Frame: up to 28 days ]
  5. Frequency of infections [ Time Frame: up to 28 days ]
  6. ICU and hospital length of stay [ Time Frame: up to 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00407147

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United States, Missouri
Saint Louis University - medical intensive care unit
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brahms AG
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Study Chair: Phil Dellinger, M.D. The Cooper Health System

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Responsible Party: Brahms AG Identifier: NCT00407147    
Other Study ID Numbers: ProBac
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Brahms AG:
bacterial infection
empiric antibiotic treatment
duration antibiotic treatment
reduce antibiotic treatment
PCT Kryptor
Intensive Care Unit
antibiotic treatment
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections