Clinical trial NCT02224716: Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals
Official title: Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community Acquired Pneumonia
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 968
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Antimicrobial use in patients hospitalized for CAP.
timeFrame: twelve months
measure: Mortality rate to 30 days
timeFrame: twelve months
Secondary outcomes:
measure: CAP severity CURB-65 or PSI registered.
timeFrame: twelve months
measure: Microbiological samples at admission.
timeFrame: twelve months
measure: Appropriate supportive treatment
timeFrame: Twelve months
measure: Empirical treatment
timeFrame: Twelve months
measure: Appropriate sequential therapy.
timeFrame: Twelve months
measure: Specific antimicrobial treatment
timeFrame: Twelve months
measure: Total duration of antibiotic therapy.
timeFrame: Twelve months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Fundación Pública Progreso y Salud
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Pilar Retamar Gentil
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen de Valme
name: Juan Enrique Corzo Delgado
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospitales Universitarios Virgen del Rocío
name: Cristina Roca Oporto
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de la Línea de la Concepción
name: Montserrat Pérez Pérez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Jerez de la Frontera
name: Salvador López Cardenas
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Antequera
name: María del Carmen Almodóvar Pulido
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Formentera
name: Fernando Nebrera Navarro
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Virgen de las Nieves
name: Rosario Javier Martínez
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Puerta del Mar
name: Francisca Guerrero Sánchez
role: PRINCIPAL_INVESTIGATOR
References: