Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)

Antibiotic Resistant Infection Clinical Trial

— NO-BACT  

Official title:

Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (The NO-BACT Project)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535324
• Other study ID #: NO-BACT (FIS-ANT-2018-01)
• Status: Completed
• Phase: N/A
• Start date: October 5, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2024
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients with negative blood cultures represent 85-90 % from all patients with a blood culture taken during hospital admissions. This population usually includes an heterogeneous group of patients that are admitted because of an infectious diseases or febrile syndrome in which performing a blood culture is required. There is scarce evidence about the clinical characteristics and the antibiotic treatment given to these patients. This project will be developped in two phases with an specific target in each one:

• Phase I (a cohort study of patient with blood cultured taken): the investigators aim to analyse the clinical and therapeutics characteristics, outcomes and antimicrobial stewardship oppotunities in a population of patients with negative blood culture. The investigators aim to compare the outcomes and antimicrobial stewardship opportunities with those in patients with positive blood culture.

• Phase II: The investigators will develop a cluster randomised control trial to evaluate the implementation of a targeted antimicrobial stewardship intervention in patients with negative blood culture (based on 3rd and 5th day audits). The effect of the intervention on the quality of antimicrobial use (duration and de-escalation), long of stay and mortality will be analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: May 31, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Health professionals in charge of patients with negative hemoculture and active antibiotherapy within 48 hours of extraction; and that belong to a clinical unit that has been assigned to the intervention arm.

Exclusion Criteria:

• Health professionals in charge of patients who, even if they meet the criteria described above, will not be considered to have a foreseeable death within <72hrs from the hemoculture extraction or a positive hemoculture in the seven days prior to the extraction of the negative hemoculture.

Related Conditions & MeSH terms

• Antibiotic Resistant Infection

Intervention

Behavioral:
• PROA for optimization
The development of a ASP based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations.

Other:
• Control
There will be no intervention

Locations

Country	Name	City	State
Spain	Puerta del Mar Hospital	Cadiz
Spain	Virgen Macarena Hospital	Seville
Spain	Lozano Blesa Hospital	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of treatment (DDT)	Days of treatment per negative hemoculture episode evaluated	It will be variable because each individual can have a different treatment days that will vary based on our previous experience between 2 and 28 days . They will be measured only once for each case included.
Secondary	Defined Daily Doses (DDDS)	Defined Daily Doses of antibiotic used in each episode	Weekly from date of randomization up to 28 days
Secondary	30-day mortality	Mortality at 30 days after the extraction of the blood culture.	From 4 to 30 days since only those patients with active antibiotherapy are included at 48 hours and with no death forecast before 48-72 hours after inclusion
Secondary	Re-hospitalization in the next 90 days	Re-hospitalization in the next 90 days after the extraction of the blood culture.	From 4 to 90 days
Secondary	Superinfection by multiresistant microorganisms	Rate of reinfection by MDR (multidrug-resistant) bacteria (according to Magiorakos AP et al criteria - International standard definitions for acquired resistance, Clin Microbiol Infect, 2011) among the intervention group patients comparing to rate in the control group patients	In the first three months after the negative blood culture
Secondary	Clostridium difficile diarrhea	Rate of patients presenting confirmed Clostridium difficile (CD) diarrhea among the intervention group patients comparing to rate of CD diarrhea about control group patients.	In the first three months after the negative blood culture