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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03148769
Other study ID # FIS-AMO-2016-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 allClick 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
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