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

This study has been terminated.
(termination due to futility (very slow patient enrollment))
Sponsor:
Information provided by (Responsible Party):
Brahms AG
ClinicalTrials.gov Identifier:
NCT00407147
First received: November 29, 2006
Last updated: January 16, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Brahms AG:

Primary Outcome Measures:
  • Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Days on antibiotics during ICU stay [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Sepsis classification [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • SOFA score (modified) [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • ICU or hospital mortality up to 28 days [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Frequency of infections [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • ICU and hospital length of stay [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: July 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407147

Locations
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
Investigators
Study Chair: Phil Dellinger, M.D. The Cooper Health System
  More Information

Publications:

Responsible Party: Brahms AG
ClinicalTrials.gov Identifier: NCT00407147     History of Changes
Other Study ID Numbers: ProBac
Study First Received: November 29, 2006
Last Updated: January 16, 2012
Health Authority: United States: Institutional Review Board
Germany: Ethics Commission

Keywords provided by Brahms AG:
bacterial infection
empiric antibiotic treatment
duration antibiotic treatment
reduce antibiotic treatment
procalcitonin
PCT Kryptor
sepsis
Intensive Care Unit
antibiotic treatment

Additional relevant MeSH terms:
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 28, 2014