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Completed

NCT Number: NCT03148769

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

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.

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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

13 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Public Health Agency Business Hospital de Poniente., El Ejido, Almería, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Epidemiology and prognostic factors of bacteremia episodes.

    Time frame: From day 0 to day 30

    • 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.

Secondary outcomes

  1. Clinical management of patients with bacteremia during the episode.

    Time frame: From day 0 to day 30

    • 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.

  2. Differences in the management between types of services, wards and hospitals.

    Time frame: From day 0 to day 30

    Comparison between different services and hospital wards of variables regarding on the management of episodes.

  3. Influence of clinical management in the prognosis.

    Time frame: From day 0 to day 30

    • Identifying prognostic factors related with mortality, clinical failure and recurrence.

  4. Developing and validating a predictive model for early and late mortality.

    Time frame: From day 0 to day 30

    • Developing and validating a predictive model for mortality based in prognostic factors related with mortality.

  5. Quality indicators in the management of bacteremia.

    Time frame: From day 0 to day 30

    • Identifying quality indicators in the management of episodes of bacteremia.

  6. Interventions made by Bacteremia Team.

    Time frame: From day 0 to day 30

    • Frequency and type of interventions made by Bacteremia Teams.
    • Impact of these interventions in the management and prognosis of episodes.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Hospital Universitario Virgen Macarena

Registry information

Official study title

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

Acronym: PRO-BAC

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
May 11, 2017
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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