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

NCT02987790 | Completed

• 1 other identifier: PCRxBestPractice
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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).

Conditions

Infection Systemic

Keywords

Intensive care; Sepsis; Biomarkers; C-reactive Protein; Antimicrobial; Systemic infection

Outcome Measures

Primary Outcomes (2)

• Duration of antibiotic therapy for the first episode of infection

  Days of treatment with antibiotics after inclusion

  1 year

• Total antibiotic exposure days per 1,000 days

  1 year

Secondary Outcomes (10)

• Costs of hospitalization

  Through study completion, an average of 1 year

• Clinical cure rate

  28 days

• Therapeutic failure

  28 days

• All cause 28-day mortality

  28 days

• All cause 90-day mortality

  90 days

Study Arms (2)

C-reactive Protein

EXPERIMENTAL

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

Best Practice

NO INTERVENTION

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.

Interventions

C-reactive protein OTHER

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.

C-reactive Protein

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Related Publications (1)

• Borges I, Carneiro R, Bergo R, Martins L, Colosimo E, Oliveira C, Saturnino S, Andrade MV, Ravetti C, Nobre V; NIIMI - Nucleo Interdisciplinar de Investigacao em Medicina Intensiva. Duration of antibiotic therapy in critically ill patients: a randomized controlled trial of a clinical and C-reactive protein-based protocol versus an evidence-based best practice strategy without biomarkers. Crit Care. 2020 Jun 1;24(1):281. doi: 10.1186/s13054-020-02946-y.

  PMID: 32487263 DERIVED

MeSH Terms

Conditions

Toxemia; Sepsis

Interventions

C-Reactive Protein

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Acute-Phase Proteins; Blood Proteins; Immunoproteins

Study Officials

• Vandack Nobre, PhD

  Medical School of the Federal University of Minas Gerais

  STUDY DIRECTOR

• Isabela Borges, MSc

  Medical School of the Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 9, 2016
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

BR (1)