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

NCT00407147 | Terminated Phase 4 DMC

• 1 other identifier: ProBac
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  28 days

Secondary Outcomes (6)

• Days on antibiotics during ICU stay

  up to 28 days

• Sepsis classification

  up to 28 days

• SOFA score (modified)

  up to 28 days

• ICU or hospital mortality up to 28 days

  up to 28 days

• Frequency of infections

  up to 28 days

Study Arms (2)

Control

NO INTERVENTION

Standard treatment

PCT

EXPERIMENTAL

PCT guided arm

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

Interventions

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

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.

Also known as: B.R.A.H.M.S, Kryptor, Procalcitonin

PCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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• Patient withdrawn from empiric antibiotic treatment before Day 4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

Sponsors & Collaborators

• Brahms AG: lead

Study Sites (3)

Saint Louis University - medical intensive care unit

St Louis, Missouri, 63110, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (8)

• 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.

  PMID: 7637145 BACKGROUND

• 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.

  PMID: 14668610 BACKGROUND

• 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.

  PMID: 14987884 BACKGROUND

• 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.

  PMID: 9462219 BACKGROUND

• 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.

  PMID: 11056723 BACKGROUND

• 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.

  PMID: 9145828 BACKGROUND

• 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.

  PMID: 8288506 BACKGROUND

• 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.

  PMID: 3928249 BACKGROUND

MeSH Terms

Conditions

Infections; Bacterial Infections; Sepsis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Phil Dellinger, M.D.

  The Cooper Health System

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

US (3)