Clinical trial NCT02987790: Duration of Antibiotic Therapy in Critically Ill Patients: C-reactive Protein-guided Therapy Versus Best Practice
Official title: Duration of Antibiotic Therapy in Critically Ill Patients: C-reactive Protein-guided Therapy Versus Best Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection Systemic
Keywords: Intensive care
Sepsis
Biomarkers
C-reactive Protein
Antimicrobial
Systemic infection
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2016-12-09
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility 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

Primary outcomes:
measure: Duration of antibiotic therapy for the first episode of infection
timeFrame: 1 year
measure: Total antibiotic exposure days per 1,000 days
timeFrame: 1 year
Secondary outcomes:
measure: Costs of hospitalization
timeFrame: Through study completion, an average of 1 year
measure: Clinical cure rate
timeFrame: 28 days
measure: Therapeutic failure
timeFrame: 28 days
measure: All cause 28-day mortality
timeFrame: 28 days
measure: All cause 90-day mortality
timeFrame: 90 days
measure: Length of ICU stay
timeFrame: 28 days
measure: Length of hospital stay
timeFrame: 28 days
measure: Nosocomial infection rate
timeFrame: 28 days
measure: Isolation of multiresistant bacteria
timeFrame: 28 days
measure: In-hospital mortality
timeFrame: An average of 28 days
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas - Universidade Federal de Minas Gerais
state: Minas Gerais
Study officials:
affiliation: Medical School of the Federal University of Minas Gerais
name: Vandack Nobre, PhD
role: STUDY_DIRECTOR
affiliation: Medical School of the Federal University of Minas Gerais
name: Isabela Borges, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.