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Duration of Antibiotic Therapy in Critically Ill Patients: C-reactive Protein-guided Therapy Versus Best Practice

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ClinicalTrials.gov Identifier: NCT02987790
Recruitment Status : Completed
First Posted : December 9, 2016
Last Update Posted : August 9, 2018
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:
The judicious use of antibiotics is one of the main measures to limit the emergence of multidrug-resistant pathogen related to excessive antimicrobial use. A recent study demonstrated that C-reactive protein (CRP) was as useful as procalcitonin (PCT) in reducing the time of antibiotic therapy in adult septic patients treated in the ICU setting. Therefore, the present study proposes to compare the time of use of antimicrobials, costs of hospitalization and clinical outcomes of interest among a group of antibiotic therapy guided by serum levels of CRP and a group of therapy based on the best practices of antibiotic therapy (Best Practice).

Condition or disease Intervention/treatment Phase
Infection Systemic Other: C-reactive protein Not Applicable

Detailed Description:
All adult patients (aged> 17 years), hospitalized at the ICU (total of 50 beds) of the Hospital das Clínicas - UFMG, with an assumed or proven infection, will be considered for inclusion. Patients who meet the inclusion and exclusion criteria will be allocated randomly into one of the following groups: 1) PCR group: antibiotic therapy will be discontinued according to serum CRP levels; 2) "Best Practice" group, length of antibiotic therapy based on the most recent guidelines in the medical literature, according to the focus and / or causative micro-organism. PCR assays shall be performed daily on serum obtained from blood collected for routine intensive care examinations up to 2 days after antibiotic withdrawal. In the PCR group, antibiotic suspension will be encouraged when levels of this marker are <35mg / L (if peak PCR below 100mg / L); or reduce 50% of the highest value (if PCR peak > 100mg / L), with a limit of seven days, if there is clinical improvement. Primary outcomes will be duration of antibiotic therapy and antibiotic-free live days corrected for 1000 days of hospitalization. Secondary outcomes will be costs, clinical cure rate, therapeutic failure, 28-day mortality, 90-day mortality, in-hospital mortality, length of hospital stay, nosocomial infection rate, recurrence of infection, and isolation of multidrug-resistant bacteria

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duration of Antibiotic Therapy in Critically Ill Patients: C-reactive Protein-guided Therapy Versus Best Practice
Actual Study Start Date : January 2017
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: C-reactive Protein
In this group, the attending physicians will be instructed to follow the decision flowchart based on the CRP values. Antibiotic suspension will be encouraged when levels of this marker are <35mg/L (if peak PCR below 100mg/L); or reduce 50% of the highest value (if PCR peak > 100mg/L), with a limit of seven days, if there is clinical improvement. If a given patient has persistently elevated CRP levels (> 100 mg/l or fall less than 50% relative to the time of inclusion), the investigators will encourage attending physicians to maintain antibiotics and to perform a careful search for persistent infection. In case of doubts, if the patient is well clinically and without signs of active infection, the duration of antibiotic therapy should be the same as suggested for the Best Practice group.
Other: C-reactive protein
PCR assays shall be performed daily on serum obtained from blood collected for routine intensive care examinations up to 2 days after antibiotic withdrawal. In the PCR group, antibiotic suspension will be encouraged when levels of this marker are <35mg / L (if peak PCR below 100mg / L); or reduce 50% of the highest value (if PCR peak> 100mg / L), with a limit of seven days, if there is clinical improvement.

No Intervention: Best Practice

Patients will be initially treated according to the current protocols used in the intensive care units. Decisions about interruption or continuation of treatment will be made according to pre-established time and also according to the clinical evolution of the patients. CRP levels will not be measured and will not be considered in the decision to discontinue antimicrobials. Any decision ultimately rests with the clinical assistants. Suggestions on the suspension of antibiotics will be provided by the researchers as follows:

  • 7 full days for most infections
  • 10 full days for pneumonia caused by Gram negative non-fermenting bacteria or Gram negative bacteria carbapenemase producing.
  • 14 days of treatment for necrotizing pneumonia, confirmed by chest computed tomography.



Primary Outcome Measures :
  1. Duration of antibiotic therapy for the first episode of infection [ Time Frame: 1 year ]
    Days of treatment with antibiotics after inclusion

  2. Total antibiotic exposure days per 1,000 days [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Costs of hospitalization [ Time Frame: Through study completion, an average of 1 year ]
    Considering Brazilian market prices

  2. Clinical cure rate [ Time Frame: 28 days ]
    Disappearance of clinical signs and symptoms present at inclusion

  3. Therapeutic failure [ Time Frame: 28 days ]
    Persistence or recurrence of the pathogen originally causing the infection.

  4. All cause 28-day mortality [ Time Frame: 28 days ]
  5. All cause 90-day mortality [ Time Frame: 90 days ]
  6. Length of ICU stay [ Time Frame: 28 days ]
  7. Length of hospital stay [ Time Frame: 28 days ]
  8. Nosocomial infection rate [ Time Frame: 28 days ]
  9. Isolation of multiresistant bacteria [ Time Frame: 28 days ]
  10. In-hospital mortality [ Time Frame: An average of 28 days ]


Information from the National Library of Medicine

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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 ≥ 18 years
  • Signed informed consent
  • Assumed or proven infection
  • Patient admitted to the unit participating in the study

Exclusion Criteria:

  • Patients with severe immunosuppression, such as severe neutropenia (<500 neut/mm3), transplantation of solid organs or cells hematopoietic, HIV infection with CD4+ < 200/mm3
  • Patients with multiple trauma, burns or surgery grid size in the last 5 days (Except surgery for focus control)
  • Use of antibiotics supposedly or proven to be effective against the infectious process in for more than 48 hours.
  • Patients undergoing palliative care.
  • Patients with death expectancy for the next 24 hours.
  • Patients with bacteremia caused by Staphylococcus aureus or Candida spp
  • Patients with infections that are known to require prolonged antibiotic therapy

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): NCT02987790


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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Study Director: Vandack Nobre, PhD Medical School of the Federal University of Minas Gerais
Principal Investigator: Isabela Borges, MSc Medical School of the Federal University of Minas Gerais

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Responsible Party: Vandack Alencar Nobre, PhD, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02987790     History of Changes
Other Study ID Numbers: PCRxBestPractice
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Vandack Alencar Nobre, Federal University of Minas Gerais:
Intensive care
Sepsis
Biomarkers
C-reactive Protein
Antimicrobial
Systemic infection

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Sepsis
Critical Illness
Infection
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation