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Establishing a control group for study B7471015 among hospitalized patients >65 Years of Age without infectious disease (UAD healthy controls)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Establishing a control group for study B7471015 among hospitalized patients >65 Years of Age without infectious disease (UAD healthy controls)
 
Region Sponsors
California - Northern
Pfizer
 
Acronym NCT No.
NCT0
 
Study Type Phase
OBSERVATIONAL
 
Purpose
The Pfizer UAD assay is a multiplex immunoassay that can detect serotype-specific S. pneumoniae capsular antigens secreted in human urine. Positivity for each serotype is based on positivity cutoff values calculated from a standard curve run with each assay together with results from study and or country/region specific positive- and negative-control urine samples, with the goal of >98% test specificity per serotype. Originally, the positivity threshold for UAD-1 and UAD-2 was determined using 400 urine samples obtained from the Netherlands and the USA from individuals undergoing elective surgery, healthy patients with stable chronic obstructive pulmonary disease (COPD) or healthy individuals with no apparent signs of pneumococcal disease. Since then, some Pfizer CAP studies have also collected control urines from healthy individuals without respiratory disease from the same geographical location as cases to evaluate the appropriateness of the cutoffs for the given population and, if required, allowed adjustment of cutpoints. This methodology accounted for geography, but not other key characteristics of the case population. The B7471015 study is using a revised methodology for control selection that relies on urines obtained from control participants who are group matched to key characteristics of the case population (e.g. season, geographic location, age, sex and selected comorbidities).
 
Detailed Description
 
 
 
Inclusion Criteria
  • UAD control participants must be:
  • 1. Residing in the United States
  • 2. Hospitalized patients =65 years of age
  • 3. Able and willing to provide a urine sample
  • 4. Able and willing to provide written informed consent or an appropriate legally authorized representative (LAR) is available to provide written informed consent UAD control participants will be group matched (within 10% of the indicated values provided in the enrollment spreadsheet) for the following:
  • • Age group (defined as 65-69, 70-79, =80 years old)
  • • Sex
  • • COPD status (stable with no exacerbations within the last 3 months)
  • • ACIP risk profile (Not At-risk/At-risk/high-risk status). At-risk/high-risk will be defined as: (matching by risk group)
  • o At risk: presence of any of the following diagnoses: chronic heart disease, diabetes mellitus, alcoholism, chronic liver disease, chronic kidney disease stage 3 or 4, dementia, stroke) and no presence of any high-risk condition (see below).
  • o High risk: asplenia, cerebrospinal fluid leak, chemotherapy medications, cochlear implant, congenital immunodeficiency, end stage renal disease/hemodialysis, generalized malignancy, HIV/AIDS, immunocompromising medications, leukemia, lymphoma, myelofibrosis, multiple myeloma, nephrotic syndrome, sickle cell hemoglobinopathy.
  • • Seasonality (Quarter 2 (Apr-Jun), Quarter 3 (Jul-Sep), Quarter 4 (Oct-Dec), and Quarter 1 (Jan-Mar)) winter (Dec-Feb), spring (Mar – May), summer (Jun-Aug) and fall (Sept-Nov)) during a 9 to 12-month period.
  • NOTE: While there will not be matching on catheter use, the percent of catheterized participants enrolled should not be greater than that observed in the B7471015 study population.
 
Exclusion Criteria
  • 1. Current or recent (last 8 weeks) suspected or confirmed infectious disease including lower respiratory infection or disease
  • 2. Known bronchial obstruction or a history of post-obstructive pneumonia.
  • 3. Acute exacerbation of COPD in the past 3 months
  • 4. Primary lung cancer or another malignancy metastatic to the lungs
  • 5. Documented temperature =38.0 degrees Celsius
  • 6. Receipt of any pneumococcal vaccine within 30 days prior to enrolment
 
Keywords and/or Specific Medical Conditions
  • Infectious Diseases
 
KP Clinical Facility
  • Roseville Medical Center
 
Clinical Area
  • Infectious Diseases


Principal Investigator:
Nicola Klein
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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