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

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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Resistant Infection
• Intervention / Treatment: Behavioral: PROA for optimization; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 659
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Cadiz, Spain, 11009
    • Puerta del Mar Hospital
  • Seville, Spain, 41009
    • Virgen Macarena Hospital
  • Zaragoza, Spain, 50009
    • Lozano Blesa Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PROA for optimization; Development of a Program for optimizing the use of antibiotics (PROA) in Spanish (Antimicrobial Stewardship Program, ASP, in English), 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. The intervention will be carried out at the cluster level (group of patients belonging to a specific hospital service that meet the inclusion criteria). The intervention will consist in carrying out the audit with recommendation on days 3 and 5-7 after the extraction of negative blood cultures to assess the possibilities of de-escalation, sequential oral therapy and end of early treatment based on the available evidence.	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.	Other: Control; There will be no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defined Daily Doses (DDDS)	Defined Daily Doses of antibiotic used in each episode	Weekly from date of randomization up to 28 days
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
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
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
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

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Study Director: Pilar Retamar Gentil, MD/PhD, Virgen Macarena Hospital

Publications and helpful links

General Publications

• Jimenez-Jorge S, Palacios-Baena ZR, Rosso-Fernandez CM, Giron-Ortega JA, Rodriguez-Bano J, Retamar P. Opportunities for antibiotic optimisation and outcome improvement in patients with negative blood cultures: study protocol for a cluster-randomised crossover trial, the NO-BACT study. BMJ Open. 2019 Dec 18;9(12):e030062. doi: 10.1136/bmjopen-2019-030062.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2018
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NO-BACT (FIS-ANT-2018-01)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No