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

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ClinicalTrials.gov Identifier: NCT03535324
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Antibiotic Resistant Infection Behavioral: PROA for optimization Other: Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (The NO-BACT Project)
Actual Study Start Date : October 5, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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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.
Control
There will be no intervention.
 Other: Control
There will be no intervention


Outcome Measures
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Primary Outcome Measures :
  1. Days of treatment (DDT) [ Time Frame: 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. ]
    Days of treatment per negative hemoculture episode evaluated


Secondary Outcome Measures :
  1. Defined Daily Doses (DDDS) [ Time Frame: Weekly from date of randomization up to 28 days ]
    Defined Daily Doses of antibiotic used in each episode

  2. 30-day mortality [ Time Frame: 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 ]
    Mortality at 30 days after the extraction of the blood culture.

  3. Re-hospitalization in the next 90 days [ Time Frame: From 4 to 90 days ]
    Re-hospitalization in the next 90 days after the extraction of the blood culture.

  4. Superinfection by multiresistant microorganisms [ Time Frame: In the first three months after the negative blood culture ]
    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

  5. Clostridium difficile diarrhea [ Time Frame: In the first three months after the negative blood culture ]
    Rate of patients presenting confirmed Clostridium difficile (CD) diarrhea among the intervention group patients comparing to rate of CD diarrhea about control group patients.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535324


Contacts
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Contact: Pilar Retamar Gentil, MD/PhD 0034 609517133 pilaretamar@hotmail.com
Contact: Clara M Rosso Fernández, MD/PhD 0034 955012144 claram.rosso.sspa@juntadeandalucia.es

Locations
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Spain
Puerta del Mar Hospital Recruiting
Cadiz, Spain, 11009
Contact: Francisca M Guerrero Sánchez         
Sub-Investigator: Montserrat M de Oca Arjona         
Sub-Investigator: Fátima Galán Sánchez         
Sub-Investigator: María E Rodríguez Mateos         
Sub-Investigator: José A Giron Gonzalez         
Virgen Macarena Hospital Recruiting
Seville, Spain, 41009
Contact: Clara M. Rosso Fernández, MD, PhD    0034 955 01 21 44    claram.rosso.sspa@juntadeandalucia.es   
Contact: Pilar Retamar Gentil, MD, PhD    0034 609517133    pilaretamar@hotmail.com   
Principal Investigator: Pilar Retamar Gentil, MD, PhD         
Sub-Investigator: José A Girón         
Sub-Investigator: Zaira Palacios         
Sub-Investigator: Marina de Cueto         
Sub-Investigator: Margarita Beltrán         
Sub-Investigator: Luisa Cantón         
Sub-Investigator: Silvia Jiménez-Jorge, PhD         
Principal Investigator: Francisca M Guerrero Sánchez         
Sub-Investigator: Montserrat Montes de Oca Arjona         
Sub-Investigator: Fátima Galán Sánchez         
Sub-Investigator: María E Rodríguez Mateos         
Sub-Investigator: José A Girón González         
Principal Investigator: Pilar Luque         
Sub-Investigator: María A Allende         
Sub-Investigator: Francisco J Ruiz         
Lozano Blesa Hospital Recruiting
Zaragoza, Spain, 50009
Contact: Pilar Luque         
Sub-Investigator: María A Allende         
Sub-Investigator: Francisco J Ruiz         
Sponsors and Collaborators
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
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Study Director: Pilar Retamar Gentil, MD/PhD Virgen Macarena Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier: NCT03535324    
Other Study ID Numbers: NO-BACT (FIS-ANT-2018-01)
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No