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

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ClinicalTrials.gov Identifier: NCT04613375
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : October 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia (CAP) Diagnostic Test: Urine sample collection Diagnostic Test: Saliva collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : March 11, 2025
Estimated Study Completion Date : March 11, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
All participants
1 arm study
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




Primary Outcome Measures :
  1. Vaccine effectiveness (VE) [ Time Frame: 4 years ]
    VE calculated as 1 minus the OR* comparing the odds of having received PCV13 for cases and controls, multiplied by 100%, overall and restricted to immunocompetent subjects only.


Secondary Outcome Measures :
  1. Proportion of CAP events for each pneumococcal serotype, PCV-13, and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes among all CAP subjects with UAD1/2 testing (overall) and among all CAP subjects with a pneumococcus identified [ Time Frame: 4 years ]
    Distribution of S. pneumoniae serotypes using blood, high-quality respiratory cultures, and a serotype-specific urinary antigen detection (UAD) assay among adults 60 years of age and older with CAP.

  2. Proportion of persons with respiratory pneumococcal carriage among adults 60 years of age and older presenting with CAP [ Time Frame: 4 years ]
    Proportion of CAP events where the pneumococcus was identified from saliva by the conventional culture or the sensitive molecular method of PCR divided by all CAP events where the subject had a valid saliva specimen test result.

  3. Proportion of participants with CAP and SP-CAP with underlying medical conditions [ Time Frame: 4 years ]
    Proportion of CAP subjects with underlying at-risk and high-risk medical conditions, overall and restricted to those with pneumococcus isolated from blood, high-quality respiratory cultures, and a serotype specific urinary antigen detection (UAD) assay

  4. Frequency of antibiotic resistance among Streptococcus pneumoniae isolates by type [ Time Frame: 4 years ]
    Proportion of S. pneumoniae isolates with antibiotic resistance identified by standard of care testing, overall and by resistance type



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04613375


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Spain
Hospital Universitario de Móstoles / Servicio de Oncología Médica Recruiting
Móstoles, Madrid, Spain, 28935
Hospital Universitario Fundación Alcorcón Recruiting
Alcorcón, Madrid, Spain, 28922
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04613375    
Other Study ID Numbers: B1851202
CIBELES ( Other Identifier: Alias Study Number )
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: October 14, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases