NCT02224716

Brief Summary

The purpose of this study is to evaluate the impact of a structured package (bundle) in reducing the use of antimicrobials and hospital stay of patients with community-acquired pneumonia (CAP), and no increase in mortality of these patients in different hospitals.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
968

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

1.4 years

First QC Date

August 22, 2014

Last Update Submit

June 11, 2015

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (2)

  • Antimicrobial use in patients hospitalized for CAP.

    It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.

    twelve months

  • Mortality rate to 30 days

    Number of death of patients hospitalized with CAP, stratified by CURB-65 score.

    twelve months

Secondary Outcomes (7)

  • CAP severity CURB-65 or PSI registered.

    twelve months

  • Microbiological samples at admission.

    twelve months

  • Appropriate supportive treatment

    Twelve months

  • Empirical treatment

    Twelve months

  • Appropriate sequential therapy.

    Twelve months

  • +2 more secondary outcomes

Study Arms (2)

Pre-intervention All patients admitted with a diagnosis of CAP

Post intervention All patient admitted with a diagnosis of CAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pre-intervention period All patients admitted with a diagnosis of CAP will be included in the participating centers during the 12 months prior to the intervention. Case detection is done through the electronic record of the basic minimum data set (MDS) (2, 36). Diagnosed patients will be selected at discharge: "simple acute bronchitis and pneumonia excluding asthma major criteria" (by diagnosis related group, DRG 541) and "simple and pleuritis in over 17 Pneumonia" (DRG 089). Post-intervention period All patients admitted with a diagnosis of CAP in the participating centers, which measures the bundle will apply prospectively included. Case detection was performed by daily review of patients admitted to target units and will be coordinated by the IP address of each center.

You may qualify if:

  • Diagnosis of CAP at hospital admission .
  • Age: 18 years or more.

You may not qualify if:

  • Patients with nosocomial pneumonia or criteria related to health care.
  • Patients with severe immunosuppression (HIV infection with \<200 CD4+ lymphocytes / mm3), neutropenia (\<500 neutrophils / mm3).
  • Patient treated with immunosuppressive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Pública Progreso y Salud

Seville, Sevilla, 41092, Spain

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Pilar Retamar Gentil

    Hospital Universitario Virgen Macarena

    STUDY DIRECTOR

  • Juan Enrique Corzo Delgado

    Hospital Universitario Virgen de Valme

    PRINCIPAL INVESTIGATOR

  • Cristina Roca Oporto

    Hospitales Universitarios Virgen del Rocío

    PRINCIPAL INVESTIGATOR

  • Montserrat Pérez Pérez

    Hospital de la Línea de la Concepción

    PRINCIPAL INVESTIGATOR

  • Salvador López Cardenas

    Hospital de Jerez de la Frontera

    PRINCIPAL INVESTIGATOR

  • María del Carmen Almodóvar Pulido

    Hospital de Antequera

    PRINCIPAL INVESTIGATOR

  • Fernando Nebrera Navarro

    Hospital de Formentera

    PRINCIPAL INVESTIGATOR

  • Rosario Javier Martínez

    University Hospital Virgen de las Nieves

    PRINCIPAL INVESTIGATOR

  • Francisca Guerrero Sánchez

    Hospital Universitario Puerta del Mar

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pilar Retamar Gentil

CONTACT

0034 955 04 04 50gestionensayosclinicos.fps@juntadeandalucia.es

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2014

First Posted

August 25, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

ES(1)