Clinical trial NCT04613375: PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia (CAP)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-11-03
Enrollment: 1821
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults, aged 60 years and over, who are hospitalized with CAP in one of the study hospitals: Hospital Universitario de Móstoles, Hospital Universitario Fundación de Alcorcón, and Hospital Rey Juan Carlos de Móstoles.

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.

Eligibility 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.

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.

Primary outcomes:
measure: Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall
timeFrame: Approximately 30 months
Secondary outcomes:
measure: Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall
timeFrame: Approximately 30 months
measure: Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified
timeFrame: Approximately 30 months
measure: Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR)
timeFrame: Approximately 30 months
measure: Percentage of CAP Participants With Underlying At-risk Medical Conditions
timeFrame: Approximately 30 months
measure: Percentage of CAP Participants With Underlying at High-Risk Medical Conditions
timeFrame: Approximately 30 months
measure: Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance
timeFrame: Approximately 30 months
Other outcomes:
Locations:
city: Getafe
country: Spain
facility: Hospital Universitarios De Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Mostoles
country: Spain
facility: Hospital Universitario de Mostoles
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan carlos
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: