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

Infection Systemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987790
• Other study ID #: PCRxBestPractice
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Infection Systemic
• Sepsis

Intervention

Other:
• C-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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Universidade Federal de Minas Gerais	Belo Horizonte	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Fundação de Amparo à Pesquisa do estado de Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of antibiotic therapy for the first episode of infection	Days of treatment with antibiotics after inclusion	1 year
Primary	Total antibiotic exposure days per 1,000 days		1 year
Secondary	Costs of hospitalization	Considering Brazilian market prices	Through study completion, an average of 1 year
Secondary	Clinical cure rate	Disappearance of clinical signs and symptoms present at inclusion	28 days
Secondary	Therapeutic failure	Persistence or recurrence of the pathogen originally causing the infection.	28 days
Secondary	All cause 28-day mortality		28 days
Secondary	All cause 90-day mortality		90 days
Secondary	Length of ICU stay		28 days
Secondary	Length of hospital stay		28 days
Secondary	Nosocomial infection rate		28 days
Secondary	Isolation of multiresistant bacteria		28 days
Secondary	In-hospital mortality		An average of 28 days