Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
PRO-BAC
Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.
1 other identifier
observational
5,320
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Typical duration for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMay 21, 2019
May 1, 2019
7 months
April 5, 2017
May 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Clinical management of patients with bacteremia during the episode.
From day 0 to day 30
Differences in the management between types of services, wards and hospitals.
From day 0 to day 30
Influence of clinical management in the prognosis.
From day 0 to day 30
Developing and validating a predictive model for early and late mortality.
From day 0 to day 30
Quality indicators in the management of bacteremia.
From day 0 to day 30
- +1 more secondary outcomes
Eligibility Criteria
It will be included all episodes of bacteremia diagnosed over a year in all participating hospitals in patients over 13 years old. It´s no possible to make a calculation of the sample size, this will depend on the type of hospital, the number of beds of the same and the number of blood cultures that are requested during the period of recruitment of the study.
You may qualify if:
- 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.
You may not qualify if:
- Bacteremias without clinical relevance
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Public Health Agency Business Hospital de Poniente.
El Ejido, Almería, 04700, Spain
General Hospital of Granollers
Granollers, Barcelona, 08402, Spain
University Hospital Mútua de Terrasa
Terrassa, Barcelona, 08221, Spain
Hospital Punta Europa
Algeciras, Cádiz, 11207, Spain
Jerez de la Frontera Hospital
Jerez de la Frontera, Cádiz, 11138, Spain
Hospital San Juan de la Cruz
Úbeda, Jaen, 23400, Spain
Hospital El Bierzo
Ponferrada, León, 24404, Spain
Costa del Sol Hospital
Márbella, Málaga, 29603, Spain
University Hospital of Vigo
Vigo, Pontevedra, 36204, Spain
University General Hospital of Alicante
Alicante, 03012, Spain
Torrecárdenas Hospital
Almería, 04009, Spain
L´ Esperit Sant ( Santa Coloma Granemet) Hospital
Barcelona, 08923, Spain
University Hospital of Burgos
Burgos, 09006, Spain
University Hospital Puerta del Mar
Cadiz, 11009, Spain
La Linea de la Concepción Hospital
Cadiz, 11300, Spain
Puerto Real Hospital
Cadiz, 11510, Spain
University Hospital Reina Sofía
Córdoba, 14004, Spain
University Hospital San Cecilio
Granada, 18012, Spain
University Hospital Virgen de las Nieves
Granada, 18014, Spain
Ciudad de Jaén Hospital
Jaén, 23007, Spain
University Hospital of León
León, 24001, Spain
University Hospital Arnau de Vilanova
Lleida, 25198, Spain
University Hospital Carlos Haya ( Málaga)
Málaga, 29010, Spain
Central University Hospital of Asturias
Oviedo, 33011, Spain
University Clinic of Navarra
Pamplona, 31008, Spain
University Hospital Marqués de Valdecilla
Santander, 30008, Spain
University Hospital Virgen Macarena
Seville, 41009, Spain
University Virgen de Valme Hospital
Seville, 41014, Spain
Universitary Hospital Cruces
Vizcaya, 48903, Spain
Related Publications (17)
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. 2003 Dec;31(12):2742-51. doi: 10.1097/01.CCM.0000098031.24329.10.
PMID: 14668610RESULTVincent 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;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
PMID: 16424713RESULTRodriguez-Bano J, Lopez-Prieto MD, Portillo MM, Retamar P, Natera C, Nuno E, Herrero M, del Arco A, Munoz A, Tellez F, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Ruiz A, Moya R, Corzo JE, Leon L, Perez-Lopez JA; SAEI/SAMPAC Bacteraemia Group. Epidemiology and clinical features of community-acquired, healthcare-associated and nosocomial bloodstream infections in tertiary-care and community hospitals. Clin Microbiol Infect. 2010 Sep;16(9):1408-13. doi: 10.1111/j.1469-0691.2009.03089.x.
PMID: 19845694RESULTLopez-Cortes LE, Del Toro MD, Galvez-Acebal J, Bereciartua-Bastarrica E, Farinas MC, Sanz-Franco M, Natera C, Corzo JE, Lomas JM, Pasquau J, Del Arco A, Martinez MP, Romero A, Muniain MA, de Cueto M, Pascual A, Rodriguez-Bano J; REIPI/SAB group. Impact of an evidence-based bundle intervention in the quality-of-care management and outcome of Staphylococcus aureus bacteremia. Clin Infect Dis. 2013 Nov;57(9):1225-33. doi: 10.1093/cid/cit499. Epub 2013 Aug 8.
PMID: 23929889RESULTPappas 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 management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1;48(5):503-35. doi: 10.1086/596757.
PMID: 19191635RESULTRodriguez-Bano J, Pano-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 R, Sierra R; Grupo de Estudio de la Infeccion Hospitalaria-Sociedad Espanola de Enfermedades Infecciosas y Microbiologia Clinica; Sociedad Espanola de Farmacia Hospitalaria; Sociedad Espanola de Medicina Preventiva, Salud Publica e Higiene. [Programs for optimizing the use of antibiotics (PROA) in Spanish hospitals: GEIH-SEIMC, SEFH and SEMPSPH consensus document]. Enferm Infecc Microbiol Clin. 2012 Jan;30(1):22.e1-22.e23. doi: 10.1016/j.eimc.2011.09.018. Epub 2011 Dec 15. Spanish.
PMID: 22178010RESULTMosier 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. No abstract available.
PMID: 23774344RESULTKaye 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.
PMID: 23737333RESULTGaynes R. Health care--associated bloodstream infections: a change in thinking. Ann Intern Med. 2002 Nov 19;137(10):850-1. doi: 10.7326/0003-4819-137-10-200211190-00015. No abstract available.
PMID: 12435223RESULTCisneros-Herreros JM, Sanchez-Gonzalez M, Prados-Blanco MT, Llanos-Rodriguez C, Vigil-Martin E, Soto-Espinosa de los Monteros B, Pachon-Diaza J. [Blood cultures in the emergency department]. Enferm Infecc Microbiol Clin. 2005 Mar;23(3):135-9. doi: 10.1157/13072162. Spanish.
PMID: 15757584RESULTFridkin 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 disease in three communities. N Engl J Med. 2005 Apr 7;352(14):1436-44. doi: 10.1056/NEJMoa043252.
PMID: 15814879RESULTRodriguez-Bano J, Navarro MD, Romero L, Martinez-Martinez L, Muniain MA, Perea EJ, Perez-Cano R, Pascual A. Epidemiology and clinical features of infections caused by extended-spectrum beta-lactamase-producing Escherichia coli in nonhospitalized patients. J Clin Microbiol. 2004 Mar;42(3):1089-94. doi: 10.1128/JCM.42.3.1089-1094.2004.
PMID: 15004058RESULTAl-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.
PMID: 25455590RESULTAl-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.
PMID: 23190091RESULTRetamar P, Portillo MM, Lopez-Prieto MD, Rodriguez-Lopez F, de Cueto M, Garcia MV, Gomez MJ, Del Arco A, Munoz A, Sanchez-Porto A, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Garcia-Figueras C, Acosta F, Corzo JE, Leon-Ruiz L, Escobar-Lara T, Rodriguez-Bano J; SAEI/SAMPAC Bacteremia Group. Impact of inadequate empirical therapy on the mortality of patients with bloodstream infections: a propensity score-based analysis. Antimicrob Agents Chemother. 2012 Jan;56(1):472-8. doi: 10.1128/AAC.00462-11. Epub 2011 Oct 17.
PMID: 22005999RESULTRetamar P, Lopez-Prieto MD, Natera C, de Cueto M, Nuno E, Herrero M, Fernandez-Sanchez F, Munoz A, Tellez F, Becerril B, Garcia-Tapia A, Carazo I, Moya R, Corzo JE, Leon L, Munoz L, Rodriguez-Bano J; Sociedad Andaluza de Enfermedades Infecciosas/Sociedad Andaluza de Microbiologia y Parasitologia Clinica and Red Espanola de Investigacion en Enfermedades Infecciosas (SAEI/SAMPAC/REIPI) Bacteremia Group; Rodriguez-Lopez F, Garcia MV, Fernandez-Galan V, del Arco A, Perez-Santos MJ, Sanchez Porto A, Torres-Tortosa M, Martin-Aspas A, Arroyo A, Garcia-Figueras C, Acosta F, Florez C, Navas P, Escobar-Lara T. Reappraisal of the outcome of healthcare-associated and community-acquired bacteramia: a prospective cohort study. BMC Infect Dis. 2013 Jul 24;13:344. doi: 10.1186/1471-2334-13-344.
PMID: 23883281RESULTRetamar P, Lopez-Prieto MD, Rodriguez-Lopez F, de Cueto M, Garcia MV, Gonzalez-Galan V, Del Arco A, Perez-Santos MJ, Tellez-Perez F, Becerril-Carral B, Martin-Aspas A, Arroyo A, Perez-Cortes S, Acosta F, Florez C, Leon-Ruiz L, Munoz-Medina L, Rodriguez-Bano J; SAEI/SAMPAC/REIPI Bacteremia Group. Predictors of early mortality in very elderly patients with bacteremia: a prospective multicenter cohort. Int J Infect Dis. 2014 Sep;26:83-7. doi: 10.1016/j.ijid.2014.04.029. Epub 2014 Jul 5.
PMID: 25008770RESULT
Related Links
Biospecimen
Microbial strains
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jesús Rodríguez-Baño, MD PhD
Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2017
First Posted
May 11, 2017
Study Start
October 1, 2016
Primary Completion
May 1, 2017
Study Completion
May 1, 2019
Last Updated
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will share