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Completed

NCT Number: NCT04613375

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

Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.

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Key information

Conditions

Community Acquired Pneumonia (CAP) Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitarios De Getafe, Getafe, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥60 years.
  • Evidence of pneumonia within first 48 hours of hospital admission
  • 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.

Exclusion criteria

  • 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).
  • Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.
  • At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.

Treatment and study plan

Urine sample collection

Diagnostic Test

Serotype specific UAD (urinary antigen detection) test

saliva collection

Diagnostic Test

Streptococcus pneumonia identification in saliva samples by culture or PCR / RSV identification in saliva samples by PCR

Primary outcomes

  1. Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall

    Time frame: Approximately 30 months

    Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure.

Secondary outcomes

  1. Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall

    Time frame: Approximately 30 months

    Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure.

  2. Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified

    Time frame: Approximately 30 months

    Percentage of CAP participants in whom streptococcus pneumoniae was identified for PCV13 and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes is reported.

  3. Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR)

    Time frame: Approximately 30 months

    Respiratory pneumococcal carriage was determined by testing saliva specimens using both conventional culture and the sensitive molecular method of PCR for the detection of two target genes (lytA and piaB).

  4. Percentage of CAP Participants With Underlying At-risk Medical Conditions

    Time frame: Approximately 30 months

    At-risk medical conditions included: alcoholism, asthma, celiac disease, chronic liver disease with hepatic failure, chronic liver disease without hepatic failure, chronic neurologic diseases, chronic obstructive pulmonary disease, coagulation factor replacement therapy, cochlear implant, congestive heart failure, coronary artery disease, cerebrospinal fluid leak, diabetes treated with medication, down syndrome, living in a nursing home, living in a long-term care facility, occupational risk with exposure to metal fumes, other chronic heart disease, other chronic lung disease, other pneumococcal disease risk factors, previous invasive pneumococcal disease, tobacco smoking (tobacco/e-cigarettes).

  5. Percentage of CAP Participants With Underlying at High-Risk Medical Conditions

    Time frame: Approximately 30 months

    High-risk medical conditions included: asplenia, cancer/malignancy (hematologic), cancer/malignancy (solid tumor), chronic kidney disease, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS), HIV - No AIDS, immunodeficiency, immunosuppressant drug therapy, multiple myeloma, organ transplantation.

  6. Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance

    Time frame: Approximately 30 months

    Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 3, 2020
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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