An interventional study of C-reactive protein in Infection Systemic, sponsored by Federal University of Minas Gerais. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-09.
Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment
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).
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
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 135 is above the median of 105 across 896 interventional studies indexed under Sepsis.
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Exclusion Criteria:
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
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.
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.
Duration of antibiotic therapy for the first episode of infection
Days of treatment with antibiotics after inclusion
Time frame: 1 year
Total antibiotic exposure days per 1,000 days
Time frame: 1 year
Costs of hospitalization
Considering Brazilian market prices
Time frame: Through study completion, an average of 1 year
Clinical cure rate
Disappearance of clinical signs and symptoms present at inclusion
Time frame: 28 days
Therapeutic failure
Persistence or recurrence of the pathogen originally causing the infection.
Time frame: 28 days
All cause 28-day mortality
Time frame: 28 days
All cause 90-day mortality
Time frame: 90 days
Length of ICU stay
Time frame: 28 days
Length of hospital stay
Time frame: 28 days
Nosocomial infection rate
Time frame: 28 days
Isolation of multiresistant bacteria
Time frame: 28 days
In-hospital mortality
Time frame: An average of 28 days
Plan to share: Undecided
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Federal University of Minas Gerais