Clinical trial NCT03535324: Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (NO-BACT)
Official title: Opportunities for Antibiotic Optimisation and Outcomes Improvement in Patients With Negative Blood Culture (The NO-BACT Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Antibiotic Resistant Infection
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 659
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Days of treatment (DDT)
timeFrame: 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 outcomes:
measure: Defined Daily Doses (DDDS)
timeFrame: Weekly from date of randomization up to 28 days
measure: 30-day mortality
timeFrame: 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
measure: Re-hospitalization in the next 90 days
timeFrame: From 4 to 90 days
measure: Superinfection by multiresistant microorganisms
timeFrame: In the first three months after the negative blood culture
measure: Clostridium difficile diarrhea
timeFrame: In the first three months after the negative blood culture
Other outcomes:
Locations:
city: Cadiz
country: Spain
facility: Puerta del Mar Hospital
city: Seville
country: Spain
facility: Virgen Macarena Hospital
city: Zaragoza
country: Spain
facility: Lozano Blesa Hospital
Study officials:
affiliation: Virgen Macarena Hospital
name: Pilar Retamar Gentil, MD/PhD
role: STUDY_DIRECTOR
References:
citation: 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.