Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do estado de Minas Gerais | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 ClÃnicas - 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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Costs of hospitalization | Considering Brazilian market prices | Through study completion, an average of 1 year |
| Clinical cure rate | Disappearance of clinical signs and symptoms present at inclusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital das ClÃnicas - Universidade Federal de Minas Gerais | Belo Horizonte | Minas Gerais | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32487263 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014115 | Toxemia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D002097 | C-Reactive Protein |
| ID | Term |
|---|---|
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000209 | Acute-Phase Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 28 days |
| Therapeutic failure | Persistence or recurrence of the pathogen originally causing the infection. | 28 days |
| All cause 28-day mortality | 28 days |
| All cause 90-day mortality | 90 days |
| Length of ICU stay | 28 days |
| Length of hospital stay | 28 days |
| Nosocomial infection rate | 28 days |
| Isolation of multiresistant bacteria | 28 days |
| In-hospital mortality | An average of 28 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001798 |
| Blood Proteins |
| D007162 | Immunoproteins |