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Use of Inflammatory Biomarkers to Guide Antibiotic Therapy in Patients With Severe Infections

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ClinicalTrials.gov Identifier: NCT00934011
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Information provided by (Responsible Party):
Vandack Alencar Nobre, Federal University of Minas Gerais

Brief Summary:
In this study the investigators aim to test if C-reactive protein (CRP)or procalcitonin(PCT) - guided strategy allows to reduce the antibiotic use in patients wiht severe sepsis and septic shock. Therefore, the safety of this intervention will be carefully measured.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Other: C-reactive protein guided antibiotic therapy Other: Procalcitonin guided antibiotic therapy Not Applicable

Detailed Description:

Methods

  • Patients and settings: Prospective controlled randomized open interventional study of antibiotic therapy in adult with severe sepsis or septic shock, admitted to the intensive care unit.

The study will be conducted in the intensive care unit (ICU) of the University Hospital Risoleta Tolentino Neves of the Federal University of Minas Gerais, Brazil. This is a 30-bed ICU with medical and surgical patients. All patients with suspected severe sepsis or septic shock admitted to the ICU will be assessed for eligibility. Patients developing severe sepsis or septic shock during their ICU stay will be also considered for enrollment.

Cultures of urine, blood, bronchoalveolar lavage fluid, and tracheal aspirates will be performed on admission and during ICU stay as clinically indicated. Blood gases and imaging exams will also be performed as clinically indicated, similarly in both groups.

  • Interventions:

All adult (> 17 years old) patients with diagnosis of severe sepsis or septic shock will receive initial antibiotic therapy based on local guidelines and susceptibility patterns, according to the decision of the treating physician. They will have circulating PCT and CRP levels measured at baseline and daily until day 4 in both groups.

Eligible patients will be reassessed on day 4 and randomized at 1:1 basis to one of the two groups since any exclusion criteria (see below) is present at that time:

Group 1 - CRP group: the duration of antibiotic therapy will be based on circulating CRP levels.

Group 2 - PCT group: the duration of antibiotic therapy will be based on circulating PCT levels.

Patients enrolled in the study will undergo daily measurements of plasma CRP (Dry Chemistry - Johnsons & Johnsons) and PCT (BRAHMS PCT VIDAS) levels up to stopping antibiotic therapy, every 48hr for two measurements in patients remaining in the ICU, and then, every 5 days.Patients will be followed up 28 days, or until death or hospital transference, which comes first. PCT and CRP results will be released in sealed envelopes. During the study period, only the results corresponding to the patient randomization group will be open; i.e., CRP for CRP group patients and PCT for PCT group patients.

- Criteria for antibiotic interruption:

The investigators will propose the interruption of antibiotics if:

  1. The patients is clinically stable, without signs of active infection
  2. CRP group: a relative reduction of 50% in baseline CRP levels, or a value lower than 25mg/dl is reached.
  3. PCT group: a relative reduction of 90% in baseline PCT levels, or if a absolute value lower than 0.1 ng/ml is reached.

The final decision regarding antibiotic therapy will be always let to the discretion of the treating physician.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Study of C-reactive Protein vs. Procalcitonin to Guide Antibiotic Therapy in Patients With Severe Sepsis and Septic Shock Admitted to the Intensive Care Unit.
Study Start Date : September 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 - C-reactive protein (CRP) guided ab therapy
Intervention on antibiotic therapy will be based on circulating CRP levels
Other: C-reactive protein guided antibiotic therapy
plasma CRP measurement to guide the duration of antibiotic therapy

Active Comparator: Group 2 - procalcitonin (PCT) guided ab therapy
Intervention on antibiotic therapy will be based on circulating PCT levels
Other: Procalcitonin guided antibiotic therapy
plasma PCT measurement to guide the duration of antibiotic therapy




Primary Outcome Measures :
  1. Duration of antibiotic therapy for the first episode of infection [ Time Frame: 28 days ]
  2. Total antibiotic exposure days per 1,000 days [ Time Frame: 28 days ]
  3. Days alive without antibiotics [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. All cause 28-day mortality [ Time Frame: 28 days ]
  2. clinical cure rate [ Time Frame: 28 days ]
  3. Infection relapse (diagnosed less than 48h after antibiotic discontinuation) [ Time Frame: 48 hours ]
  4. Length of ICU stay [ Time Frame: Whole hospitalization ]
  5. Nosocomial infection rate [ Time Frame: 28 days ]
  6. In-hospital mortality [ Time Frame: 28 days ]
  7. sepsis-associated death [ Time Frame: 28 days ]
  8. Nosocomial superinfection (diagnosed more than 48hous after discontinuation of the antibiotic therapy given to the first episode of infection) [ Time Frame: 28 days ]
  9. Isolation of resistant bacteria [ Time Frame: 28 days ]
  10. Length of hospital stay [ Time Frame: The whole hospitalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 17 years
  • patients in intensive care unit
  • signed informed consent
  • suspected or confirmed severe sepsis or septic shock

Exclusion Criteria:

  • Infections caused by Listeria spp, Legionella pneumophilia, Mycobacterium tuberculosis
  • Bacteremia due S. aureus
  • Infections requiring prolonged therapies, such as endocarditis, cerebral abscess, chronic osteomyelitis
  • Suspected or confirmed infection caused by virus, parasites
  • Infections caused by P. aeruginosa ou A. baumannii
  • Severe immunosuppression (ex: AIDS, post bone-marrow transplant,cystic fibrosis)
  • Traumatism latest five days
  • Surgery latest 5 days
  • Carcinoid tumor, lung cancer, medullary thyroid cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934011


Locations
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Brazil
Hospital das Clínicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, Brazil
Sponsors and Collaborators
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Investigators
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Principal Investigator: Vandack A Nobre, PhD Medical School of the Federal University of Minas Gerais
Study Chair: Carolina F Oliveira, MD Idem
Study Chair: Fernando A Botoni, PhD Idem

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vandack Alencar Nobre, Associate Professor, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT00934011     History of Changes
Other Study ID Numbers: PRO_Protocol01
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: February 3, 2016
Last Verified: June 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results published in the Critical Care Medicine, 2013
Keywords provided by Vandack Alencar Nobre, Federal University of Minas Gerais:
C-reactive protein
procalcitonin
sepsis
antibiotic therapy
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock