Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors

Bacteremia Clinical Trial

— PRO-BAC  

Official title:

Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03148769
• Other study ID #: FIS-AMO-2016-01
• Status: Completed
• Start date: October 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Bacteremia

The Hypothesis of the study are the followings:

• To demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia.

• Since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve.

• To identify quality indicators in the management of bacteremia.

• To demonstrate that some interventions made by Bacteremia Team pose relevant impact in the prognosis of bacteremia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5320
• Est. completion date: May 2019
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Every episode of bacteremia in patients older than 13 years old, confirmed microbiologically and clinically significant (presence of clinical sepsis data at diagnosis) should be prospectively included on the basis of standard criteria.

• Episodes of transient bacteremia may be included.

• Drugs will be prescribed in the usual way, according to the conditions established in the authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include to the patient in the study.

Exclusion Criteria:

• Bacteremias without clinical relevance

Related Conditions & MeSH terms

• Bacteremia

Locations

Country	Name	City	State
Spain	Hospital Punta Europa	Algeciras	Cádiz
Spain	University General Hospital of Alicante	Alicante
Spain	Torrecárdenas Hospital	Almeria
Spain	L´ Esperit Sant ( Santa Coloma Granemet) Hospital	Barcelona
Spain	University Hospital of Burgos	Burgos
Spain	La Linea de la Concepción Hospital	Cádiz
Spain	Puerto Real Hospital	Cádiz
Spain	University Hospital Puerta del Mar	Cádiz
Spain	University Hospital Reina Sofía	Cordoba
Spain	Public Health Agency Business Hospital de Poniente.	El Ejido	Almería
Spain	University Hospital San Cecilio	Granada
Spain	University Hospital Virgen de las Nieves	Granada
Spain	General Hospital of Granollers	Granollers	Barcelona
Spain	Ciudad de Jaén Hospital	Jaen
Spain	Jerez de la Frontera Hospital	Jerez de la Frontera	Cádiz
Spain	University Hospital of León	León
Spain	University Hospital Arnau de Vilanova	Lleida
Spain	University Hospital Carlos Haya ( Málaga)	Málaga
Spain	Costa del Sol Hospital	Márbella	Málaga
Spain	Central University Hospital of Asturias	Oviedo
Spain	University Clinic of Navarra	Pamplona
Spain	Hospital El Bierzo	Ponferrada	León
Spain	University Hospital Marqués de Valdecilla	Santander
Spain	University Hospital Virgen Macarena	Sevilla
Spain	University Virgen de Valme Hospital	Sevilla
Spain	University Hospital Mútua de Terrasa	Terrassa	Barcelona
Spain	Hospital San Juan de la Cruz	Ubeda	Jaen
Spain	University Hospital of Vigo	Vigo	Pontevedra
Spain	Universitary Hospital Cruces	Vizcaya

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	Hospital Universitario Virgen Macarena

Country where clinical trial is conducted

Spain, 

References & Publications (17)

Al-Hasan MN, Juhn YJ, Bang DW, Yang HJ, Baddour LM. External validation of bloodstream infection mortality risk score in a population-based cohort. Clin Microbiol Infect. 2014 Sep;20(9):886-91. doi: 10.1111/1469-0691.12607. Epub 2014 Mar 26. — View Citation

Al-Hasan MN, Lahr BD, Eckel-Passow JE, Baddour LM. Predictive scoring model of mortality in Gram-negative bloodstream infection. Clin Microbiol Infect. 2013 Oct;19(10):948-54. doi: 10.1111/1469-0691.12085. Epub 2012 Nov 27. — View Citation

Cisneros-Herreros JM, Sánchez-González M, Prados-Blanco MT, Llanos-Rodríguez C, Vigil-Martín E, Soto-Espinosa de los Monteros B, Pachón-Díaza J. [Blood cultures in the emergency department]. Enferm Infecc Microbiol Clin. 2005 Mar;23(3):135-9. Spanish. — View Citation

Fridkin SK, Hageman JC, Morrison M, Sanza LT, Como-Sabetti K, Jernigan JA, Harriman K, Harrison LH, Lynfield R, Farley MM; Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Methicillin-resistant Staphylococcus aureus d — View Citation

Garnacho-Montero J, Garcia-Garmendia JL, Barrero-Almodovar A, Jimenez-Jimenez FJ, Perez-Paredes C, Ortiz-Leyba C. Impact of adequate empirical antibiotic therapy on the outcome of patients admitted to the intensive care unit with sepsis. Crit Care Med. 20 — View Citation

Gaynes R. Health care--associated bloodstream infections: a change in thinking. Ann Intern Med. 2002 Nov 19;137(10):850-1. — View Citation

Kaye KS. Antimicrobial de-escalation strategies in hospitalized patients with pneumonia, intra-abdominal infections, and bacteremia. J Hosp Med. 2012;7 Suppl 1:S13-21. doi: 10.1002/jhm.983. Review. — View Citation

López-Cortés LE, Del Toro MD, Gálvez-Acebal J, Bereciartua-Bastarrica E, Fariñas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martínez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodríguez-Baño J; REIPI/SAB group. Impact of — View Citation

Mosier MJ, Ton-That H. Making the case for de-escalation therapy in ventilator-associated pneumonia once again. Crit Care Med. 2013 Jul;41(7):1810-1. doi: 10.1097/CCM.0b013e31828ce949. — View Citation

Pappas PG, Kauffman CA, Andes D, Benjamin DK Jr, Calandra TF, Edwards JE Jr, Filler SG, Fisher JF, Kullberg BJ, Ostrosky-Zeichner L, Reboli AC, Rex JH, Walsh TJ, Sobel JD; Infectious Diseases Society of America. Clinical practice guidelines for the manage — View Citation

Retamar P, López-Prieto MD, Nátera C, de Cueto M, Nuño E, Herrero M, Fernández-Sánchez F, Muñoz A, Téllez F, Becerril B, García-Tapia A, Carazo I, Moya R, Corzo JE, León L, Muñoz L, Rodríguez-Baño J; Sociedad Andaluza de Enfermedades Infecciosas/Sociedad — View Citation

Retamar P, López-Prieto MD, Rodríguez-López F, de Cueto M, García MV, González-Galan V, Del Arco A, Pérez-Santos MJ, Téllez-Pérez F, Becerril-Carral B, Martín-Aspas A, Arroyo A, Pérez-Cortés S, Acosta F, Florez C, León-Ruiz L, Muñoz-Medina L, Rodríguez-Ba — View Citation

Retamar P, Portillo MM, López-Prieto MD, Rodríguez-López F, de Cueto M, García MV, Gómez MJ, Del Arco A, Muñoz A, Sánchez-Porto A, Torres-Tortosa M, Martín-Aspas A, Arroyo A, García-Figueras C, Acosta F, Corzo JE, León-Ruiz L, Escobar-Lara T, Rodríguez-Ba — View Citation

Rodríguez-Baño J, López-Prieto MD, Portillo MM, Retamar P, Natera C, Nuño E, Herrero M, del Arco A, Muñoz A, Téllez F, Torres-Tortosa M, Martín-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, León L, Pérez-López JA; SAEI/SAMPAC Bacteraemia Group. Epidemiolog — View Citation

Rodríguez-Baño J, Navarro MD, Romero L, Martínez-Martínez L, Muniain MA, Perea EJ, Pérez-Cano R, Pascual A. Epidemiology and clinical features of infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in nonhospitalized patients. — View Citation

Rodríguez-Baño J, Paño-Pardo JR, Alvarez-Rocha L, Asensio A, Calbo E, Cercenado E, Cisneros JM, Cobo J, Delgado O, Garnacho-Montero J, Grau S, Horcajada JP, Hornero A, Murillas-Angoiti J, Oliver A, Padilla B, Pasquau J, Pujol M, Ruiz-Garbajosa P, San Juan — View Citation

Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiology and prognostic factors of bacteremia episodes.	Global incidence and per type of acquisition.; Global etiology and per type of acquisition.; Frequency of multiresistant and emerging microorganism.; Source of bacteremia.; Clinical severity of presentation.; Clinical failure, mortality at day 7, mortality at day 30, recurrence, length of stay and re-admission at hospital.	From day 0 to day 30
Secondary	Clinical management of patients with bacteremia during the episode.	Antibiotic therapy used during the episodes (empirical and targeted).; Non antibiotic therapy/support therapy used during the episode.; Frequency of focus search and adequate control.	From day 0 to day 30
Secondary	Differences in the management between types of services, wards and hospitals.	Comparison between different services and hospital wards of variables regarding on the management of episodes.	From day 0 to day 30
Secondary	Influence of clinical management in the prognosis.	- Identifying prognostic factors related with mortality, clinical failure and recurrence.	From day 0 to day 30
Secondary	Developing and validating a predictive model for early and late mortality.	- Developing and validating a predictive model for mortality based in prognostic factors related with mortality.	From day 0 to day 30
Secondary	Quality indicators in the management of bacteremia.	- Identifying quality indicators in the management of episodes of bacteremia.	From day 0 to day 30
Secondary	Interventions made by Bacteremia Team.	Frequency and type of interventions made by Bacteremia Teams.; Impact of these interventions in the management and prognosis of episodes.	From day 0 to day 30

External Links

•   European Centre for Disease Prevention and Control (ECDC)
•   European Surveillance of Antimicrobial Consumption Network (ESAC-Net).