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Completed

NCT Number: NCT02987790

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2016
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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