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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PROA for optimization | Experimental | 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. |
|
| Control | Other | There will be no intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROA for optimization | Behavioral | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Retamar Gentil, MD/PhD | Virgen Macarena Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerta del Mar Hospital | Cadiz | 11009 | Spain | |||
| Virgen Macarena Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31857298 | Derived | 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. |
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| Control | Other | There will be no intervention |
|
| 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 |
| Seville |
| 41009 |
| Spain |
| Lozano Blesa Hospital | Zaragoza | 50009 | Spain |