Infection Systemic
Conditions
Keywords
Intensive care, Sepsis, Biomarkers, C-reactive Protein, Antimicrobial, Systemic infection
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
Interventions
OTHERC-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.
Sponsors
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of antibiotic therapy for the first episode of infection | 1 year | Days of treatment with antibiotics after inclusion |
| Total antibiotic exposure days per 1,000 days | 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic failure | 28 days | Persistence or recurrence of the pathogen originally causing the infection. |
| All cause 28-day mortality | 28 days | — |
| All cause 90-day mortality | 90 days | — |
| Length of ICU stay | 28 days | — |
| Costs of hospitalization | Through study completion, an average of 1 year | Considering Brazilian market prices |
| Nosocomial infection rate | 28 days | — |
| Isolation of multiresistant bacteria | 28 days | — |
| In-hospital mortality | An average of 28 days | — |
| Length of hospital stay | 28 days | — |
| Clinical cure rate | 28 days | Disappearance of clinical signs and symptoms present at inclusion |
Countries
Brazil
Outcome results
None listed