Community Acquired PneumoniaNCT02224716
Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals
An observational study of Community Acquired Pneumonia, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community Acquired Pneumonia
- How many people
- 968 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of CAP at hospital admission .
- Age: 18 years or more.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Fundación Pública Progreso y Salud
Seville, Sevilla, 41092
María del Mar Benjumea Vargas, 0034955040450, gestionensayosclinicos.fps@juntadeandalucia.es
About this study
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.
- Conditions
- Community Acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention All patients admitted with a diagnosis of CAP | Not described | |
| Post intervention All patient admitted with a diagnosis of CAP | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial use in patients hospitalized for CAP.
It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.
Measured: twelve months
Mortality rate to 30 days
Number of death of patients hospitalized with CAP, stratified by CURB-65 score.
Measured: twelve months
Secondary outcomes (7)
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.
Measured: twelve months
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.
Measured: twelve months
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.
Measured: Twelve months
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.
Measured: Twelve months
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.
Measured: Twelve months
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
Measured: Twelve months
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.
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community Acquired PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 968 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pilar Retamar Gentil, Study director, Hospital Universitario Virgen MacarenaJuan Enrique Corzo Delgado, Principal investigator, Hospital Universitario Virgen de ValmeCristina Roca Oporto, Principal investigator, Hospitales Universitarios Virgen del RocíoMontserrat Pérez Pérez, Principal investigator, Hospital de la Línea de la ConcepciónSalvador López Cardenas, Principal investigator, Hospital de Jerez de la FronteraMaría del Carmen Almodóvar Pulido, Principal investigator, Hospital de AntequeraFernando Nebrera Navarro, Principal investigator, Hospital de FormenteraRosario Javier Martínez, Principal investigator, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224716
- Sponsor's protocol ID
- FIS-ANT-2014-01
- Status last verified
- Jun 2015
- First submitted
- 22 Aug 2014
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Intervention Program to Optimize the Clinical Management of Community-acquired Pneumonia in Hospitals
- ClinicalTrials.gov ID
- NCT02224716
- Acronym / sponsor ID
- FIS-ANT-2014-01
- Conditions
- Community Acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 968 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention All patients admitted with a diagnosis of CAP | – | – |
| Post intervention All patient admitted with a diagnosis of CAP | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of CAP at hospital admission .
- Age: 18 years or more.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antimicrobial use in patients hospitalized for CAP.
Time frame: twelve months
It is measured in defined daily doses (DDD) per 100 hospital stay of patients hospitalized with CAP.
Mortality rate to 30 days
Time frame: twelve months
Number of death of patients hospitalized with CAP, stratified by CURB-65 score.
7 secondary outcomes
CAP severity CURB-65 or PSI registered.
Time frame: twelve months
Microbiological samples at admission.
Time frame: twelve months
Appropriate supportive treatment
Time frame: Twelve months
Empirical treatment
Time frame: Twelve months
Appropriate sequential therapy.
Time frame: Twelve months
Specific antimicrobial treatment
Time frame: Twelve months
Total duration of antibiotic therapy.
Time frame: Twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pilar Retamar Gentil study director
Hospital Universitario Virgen Macarena
Juan Enrique Corzo Delgado principal investigator
Hospital Universitario Virgen de Valme
Cristina Roca Oporto principal investigator
Hospitales Universitarios Virgen del Rocío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community Acquired Pneumonia, run by Fundación Pública Andaluza Progreso y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pilar Retamar Gentil (0034 955 04 04 50, gestionensayosclinicos.fps@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial use in patients hospitalized for CAP. (time frame: twelve months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.