PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older

NCT04613375

Last updated date
Study Location
Hospital Universitario Fundacion Alcorcon
Alcorcon, Madrid, 28922, Spain
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Community Acquired Pneumonia (CAP)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Age ≥60 years.

2. Evidence of pneumonia within first 48 hours of hospital admission

3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

4. Residence in districts of Fuenlabrada or Alcorcón in any setting (including residents living in community, nursing home, or other settings).

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. Any patient who develops signs and symptoms of pneumonia after being hospitalized for
≥48 hours (either at current hospital, another transferring hospital, or a combination
of these).


2. Previously enrolled subjects readmitted ≤14 days after discharge for their study
qualifying admission.


3. At the time of enrollment, pneumonia has been excluded as the diagnosis or another
diagnosis confirmed.

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Advanced Information
Descriptive Information
Brief Title  ICMJE PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
Official Title  ICMJE A Low Intervention Study of the Effectiveness Of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Against Vaccine Type Pneumococcal Hospitalised Community Acquired Pneumonia (CAP) in Adults 60 Years and Older Using A Test Negative Design Study in A Well-Defined Area of the South of Madrid Region
Brief Summary Multicenter, prospective, epidemiological, hospital-based surveillance study involving adults 60 years of age and older hospitalized with CAP in the participating hospital sites.
Detailed Description PCV13 efficacy for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and invasive pneumococcal disease (IPD) was established in the Community-acquired Pneumonia Immunization Trial in Adults (CAPITA) aged 65 and older. However, there are still few available real-life effectiveness estimates in adults. The aim of this study is to evaluate the PCV13 vaccine effectiveness (VE) against hospitalised VT-pneumococcal CAP among adults aged ?60 years in the Region of Madrid (Spain). Determination of the effectiveness of PCV13 to prevent hospitalised vaccine-type (VT)-pneumococcal CAP among adults aged ?60 years in Madrid will be evaluated using a test- negative design study, overall and among immunocompetent persons only.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Community Acquired Pneumonia (CAP)
Intervention  ICMJE
  • Diagnostic Test: Urine sample collection
    Serotype specific UAD (urinary antigen detection) test
  • Diagnostic Test: Saliva collection
    Streptococcus pneumonia identification in saliva samples by culture or PCR
Study Arms  ICMJE All participants
1 arm study
Interventions:
  • Diagnostic Test: Urine sample collection
  • Diagnostic Test: Saliva collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2020)
3600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2025
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ?60 years.
  2. Evidence of pneumonia within first 48 hours of hospital admission
  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  4. Residence in districts of Fuenlabrada or Alcorcón in any setting (including residents living in community, nursing home, or other settings).

Exclusion Criteria:

  1. Any patient who develops signs and symptoms of pneumonia after being hospitalized for ?48 hours (either at current hospital, another transferring hospital, or a combination of these).
  2. Previously enrolled subjects readmitted ?14 days after discharge for their study qualifying admission.
  3. At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04613375
Other Study ID Numbers  ICMJE B1851202
CIBELES ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP