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

NCT ID: NCT00407147

Last Updated: 2012-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-06-30

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.

Conditions

Infection; Bacterial Infection; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

PCT

PCT guided arm

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brahms AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phil Dellinger, M.D.

Role: STUDY_CHAIR

The Cooper Health System

Locations

Saint Louis University - medical intensive care unit

St Louis, Missouri, United States

Cooper University Hospital

Camden, New Jersey, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 7637145 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14668610 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14987884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9462219 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11056723 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9145828 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8288506 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3928249 (View on PubMed)

Other Identifiers

ProBac

Identifier Type: -

Identifier Source: org_study_id