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

Completed

Conditions: Community Acquired Pneumonia (CAP)

Interventions: Diagnostic Test: Urine sample collection
Diagnostic Test: Saliva collection

Registration Number: NCT04613375

Lead Sponsor: Pfizer

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1821

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Urine sample collection	-
All participants	Saliva collection	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall	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 Outcome Measures

Name	Time	Method
Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall	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.
Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified	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.
Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR)	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).
Percentage of CAP Participants With Underlying At-risk Medical Conditions	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).
Percentage of CAP Participants With Underlying at High-Risk Medical Conditions	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.
Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance	Approximately 30 months	Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure.

Trial Locations

Locations (5): Hospital Universitarios De Getafe
🇪🇸
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
🇪🇸
Leganés, Madrid, Spain
Hospital Universitario Fundación Alcorcón
🇪🇸
Alcorcón, Spain
Hospital Universitario de Mostoles
🇪🇸
Mostoles, Spain
Hospital Universitario Rey Juan carlos
🇪🇸
Móstoles, Spain