Bacteremia Clinical Trial
— PRO-BACOfficial title:
Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.
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 |
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 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Hospital Universitario Virgen Macarena |
Spain,
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* Note: There are 17 references in all — Click here to view all references
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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