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InfectionPhase 4NCT00407147

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

A Phase 4 study testing Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor in people with Infection and Bacterial Infection, run by Brahms AG at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection, Bacterial Infection, Sepsis
What is being tested?
Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
3 sitesUnited States
Study dates
Jul 2008to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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  • Patient withdrawn from empiric antibiotic treatment before Day 4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)
Show all 16Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Saint Louis University - medical intensive care unit

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor
Keywords
bacterial infection, empiric antibiotic treatment, duration antibiotic treatment, reduce antibiotic treatment, procalcitonin, PCT Kryptor, sepsis, Intensive Care Unit, antibiotic treatment
Medical subject headings
Infections, Bacterial Infections, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

    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.

Study groups in NCT00407147
Study groupRoleWhat they receive
ControlNo interventionStandard treatment
PCTExperimentalPCT guided arm
Receives: Device: Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 28 days

Secondary outcomes (6)

  1. Days on antibiotics during ICU stay

    Measured: up to 28 days

  2. Sepsis classification

    Measured: up to 28 days

  3. SOFA score (modified)

    Measured: up to 28 days

  4. ICU or hospital mortality up to 28 days

    Measured: up to 28 days

  5. Frequency of infections

    Measured: up to 28 days

  6. ICU and hospital length of stay

    Measured: up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2006 (estimated)
  2. Study startJul 2008
  3. Primary completionJun 2009
  4. Study completionJun 2009

Why it stopped: termination due to futility (very slow patient enrollment)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00407147
Sponsor's protocol ID
ProBac
Status last verified
Jan 2012
First submitted
29 Nov 2006
Last updated
18 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 7637145

  • 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.

    PubMed 14668610

  • 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.

    PubMed 14987884

  • 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.

    PubMed 9462219

  • 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.

    PubMed 11056723

  • 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.

    PubMed 9145828

  • 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.

    PubMed 8288506

  • 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.

    PubMed 3928249

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Procalcitonin assay - B.R.A.H.M.S PCT sensitive Kryptor in people with Infection and Bacterial Infection, run by Brahms AG at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: termination due to futility (very slow patient enrollment)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days on antibiotics beginning with day 4 until the first day without antibiotics (up to max. 28 days follow up) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00407147, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2012.

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