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

Study Overview
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Brief Summary
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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.

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

Conditions
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Antibiotic Resistant Infection

Intervention / Treatment
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* Behavioral: PROA for optimization
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PROA for optimization<br>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<br>* 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.<br>|
| Other: Control<br>There will be no intervention. | Other: Control<br>* There will be no intervention<br>|

What is the study measuring?
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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 |