Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals

Community Acquired Pneumonia Clinical Trial

Official title:

Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02224716
• Other study ID #: FIS-ANT-2014-01
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2014
• Last updated: June 11, 2015
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: Pilar Retamar Gentil
• Phone: 0034 955 04 04 50
• Email: gestionensayosclinicos.fps[@]juntadeandalucia.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 968
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Community Acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
Spain	Fundación Pública Progreso y Salud	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Mortality rate to 30 days	Number of death of patients hospitalized with CAP, stratified by CURB-65 score.	twelve months	Yes
Secondary	CAP severity CURB-65 or PSI registered.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Numbers of doctors who register on the clinical history the evaluation of CAP severity by CURB-65 or PSI at hospitalization.	twelve months	No
Secondary	Microbiological samples at admission.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Numbers of doctors who taking all microbiological samples recommended in the guideline in the first 6 hours of patient admission.	twelve months	No
Secondary	Appropriate supportive treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who take supportive treatment according to guideline during the hospitalization.	Twelve months	No
Secondary	Empirical treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribed empirical treatment according to the guideline at admission.	Twelve months	No
Secondary	Appropriate sequential therapy.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who switch to oral therapy according to guideline.	Twelve months	No
Secondary	Specific antimicrobial treatment	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribed the specific antimicrobial treatment defined in the guideline	Twelve months	No
Secondary	Total duration of antibiotic therapy.	Implementation of quality indicators in the management of CAP. They are expressed as dichotomous variables (yes / no): Number of doctors who prescribe an antimicrobial treatment during 7 days or less, or 5 days or less after clinical improvement.	Twelve months	No