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

Primary Purpose

Infection, Bacterial Infection, Sepsis

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor

About this trial

This is an interventional treatment trial for Infection focused on measuring bacterial infection, empiric antibiotic treatment, duration antibiotic treatment, reduce antibiotic treatment, procalcitonin, PCT Kryptor, sepsis, Intensive Care Unit, antibiotic treatment

Eligibility Criteria

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

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Patient withdrawn from empiric antibiotic treatment before Day 4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

Sites / Locations

Saint Louis University - medical intensive care unit
Cooper University Hospital
Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

PCT

Arm Description

Standard treatment

PCT guided arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Days on antibiotics during ICU stay

Sepsis classification

SOFA score (modified)

ICU or hospital mortality up to 28 days

Frequency of infections

ICU and hospital length of stay

Full Information

NCT ID

NCT00407147

First Posted

November 29, 2006

Last Updated

January 16, 2012

Sponsor

Brahms AG

1. Study Identification

Unique Protocol Identification Number

NCT00407147

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Why Stopped

termination due to futility (very slow patient enrollment)

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brahms AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

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

Infection, Bacterial Infection, Sepsis

Keywords

bacterial infection, empiric antibiotic treatment, duration antibiotic treatment, reduce antibiotic treatment, procalcitonin, PCT Kryptor, sepsis, Intensive Care Unit, antibiotic treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Standard treatment

Arm Title

PCT

Arm Type

Experimental

Arm Description

PCT guided arm

Intervention Type

Device

Intervention Name(s)

Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Days on antibiotics during ICU stay

Time Frame

up to 28 days

Title

Sepsis classification

Time Frame

up to 28 days

Title

SOFA score (modified)

Time Frame

up to 28 days

Title

ICU or hospital mortality up to 28 days

Time Frame

up to 28 days

Title

Frequency of infections

Time Frame

up to 28 days

Title

ICU and hospital length of stay

Time Frame

up to 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phil Dellinger, M.D.

Organizational Affiliation

The Cooper Health System

Official's Role

Study Chair

Facility Information:

Facility Name

Saint Louis University - medical intensive care unit

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Cooper University Hospital

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103

Country

United States

Facility Name

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7637145

Citation

Vincent JL, Bihari DJ, Suter PM, Bruining HA, White J, Nicolas-Chanoin MH, Wolff M, Spencer RC, Hemmer M. The prevalence of nosocomial infection in intensive care units in Europe. Results of the European Prevalence of Infection in Intensive Care (EPIC) Study. EPIC International Advisory Committee. JAMA. 1995 Aug 23-30;274(8):639-44.

Results Reference

background

PubMed Identifier

14668610

Citation

Garnacho-Montero J, Garcia-Garmendia JL, Barrero-Almodovar A, Jimenez-Jimenez FJ, Perez-Paredes C, Ortiz-Leyba C. Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis. Crit Care Med. 2003 Dec;31(12):2742-51. doi: 10.1097/01.CCM.0000098031.24329.10.

Results Reference

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PubMed Identifier

14987884

Citation

Christ-Crain M, Jaccard-Stolz D, Bingisser R, Gencay MM, Huber PR, Tamm M, Muller B. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004 Feb 21;363(9409):600-7. doi: 10.1016/S0140-6736(04)15591-8.

Results Reference

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PubMed Identifier

9462219

Citation

Rau B, Steinbach G, Gansauge F, Mayer JM, Grunert A, Beger HG. The potential role of procalcitonin and interleukin 8 in the prediction of infected necrosis in acute pancreatitis. Gut. 1997 Dec;41(6):832-40. doi: 10.1136/gut.41.6.832.

Results Reference

background

PubMed Identifier

11056723

Citation

Meisner M, Tschaikowsky K, Palmaers T, Schmidt J. Comparison of procalcitonin (PCT) and C-reactive protein (CRP) plasma concentrations at different SOFA scores during the course of sepsis and MODS. Crit Care. 1999;3(1):45-50. doi: 10.1186/cc306.

Results Reference

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PubMed Identifier

9145828

Citation

Bergmans DC, Bonten MJ, Gaillard CA, van Tiel FH, van der Geest S, de Leeuw PW, Stobberingh EE. Indications for antibiotic use in ICU patients: a one-year prospective surveillance. J Antimicrob Chemother. 1997 Apr;39(4):527-35. doi: 10.1093/jac/39.4.527.

Results Reference

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PubMed Identifier

8288506

Citation

Roder BL, Nielsen SL, Magnussen P, Engquist A, Frimodt-Moller N. Antibiotic usage in an intensive care unit in a Danish university hospital. J Antimicrob Chemother. 1993 Oct;32(4):633-42. doi: 10.1093/jac/32.4.633.

Results Reference

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PubMed Identifier

3928249

Citation

Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

Results Reference

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

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