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

Sponsor

Brahms AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT00407147

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

3.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 :

Jul 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

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

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 Names:

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
ICU and hospital length of stay [up to 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Louis University - medical intensive care unit	Saint Louis	Missouri	United States	63110
2	Cooper University Hospital	Camden	New Jersey	United States	08103
3	Rhode Island Hospital	Providence	Rhode Island	United States	02903