Pilot for a Test-Negative Case-Control Study to Evaluate the Effectiveness of a New Adult Pneumococcal Vaccine Against Pneumococcal Pneumonia in Older Adults
Samir Gupta, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
Assess vaccine history to evaluate completeness of data through review of site-specific sources (e.g., EMR, registry, provider outreach) Assess completeness of medical history and other key covariates based on EMR and/or hospital admission data.
Detailed description of study
What will happen during the study?
Conduct limited dry run of end-to-end processes for sample collection, laboratory processes, and imaging retrieval including:
- Urine sample collection, handling, storing, and shipping to a designated laboratory (where applicable), data processing, serotype-specific urinary antigen detection (SSUAD) testing and onsite BinaxNOW pneumococcal urinary antigen testing and analysis at site laboratory
- Blood sample collection and collection of other standard of care samples (e.g., sputum, pleural fluid, bronchoalveolar lavage (BAL), endotracheal aspirate, cerebrospinal fluid (CSF), synovial fluid), culture isolates for positive pneumococcal cultures, handling, storing, and shipping to a designated laboratory, pneumococcal antigen detection (PAD) testing
- Imaging (e.g., chest X-ray) access, retrieval, and file transfer of image and report Estimate study enrollment rates, number of sites needed and evaluability rate (including prevalence of pneumococcal vaccination) Evaluate site start-up activities of sites and countries, and Assess sites operational approach to study implementation and obtain feedback on feasibility of data collection and laboratory processes in advance of the full TND study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Pneumococcal Pneumonia
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Age: 65 years or above
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Gender: All
Inclusion Criteria
1. Male or female, ≥65 years of age, at the time of signing informed consent
2. The patient (or legally acceptable representative (LAR)) has provided documented informed consent
for the study
3. Assessed in hospital or referred to hospital from urgent care setting with clinical suspicion of CAP
(Note: Patients referred from assisted living care/centers will be eligible)
4. Has ≥2 of the following clinical signs or symptoms:
• fever (oral temperature >38.0°C/100.4°F or tympanic temperature >38.5°C/101.2°F),
• hypothermia (<35.5°C/95.9°F measured by a healthcare provider),
• chills or rigors,
• pleuritic chest pain,
• new or worsening cough,
• sputum production,
• dyspnea (shortness of breath),
• tachypnea (respiratory rate >20/min),
• malaise, or
• abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary
consolidation including dullness on percussion, bronchial breath sounds, or egophony)
5. Availability of imaging studies to support the CAP diagnosis
The investigator or qualified designee will review all inclusion and exclusion criteria to ensure that the
patient qualifies for the study.
Exclusion Criteria
1. Transfer from other hospitals, skilled nursing care, or acute rehabilitation
2. Aspiration pneumonia, hospital-acquired bacterial pneumonia (if a patient develops signs or symptoms
48 hours after being hospitalized), or ventilator-associated bacterial pneumonia
3. Patients hospitalized for pneumonia or respiratory infection within the last 30 days
4. Patients with known bronchial obstruction or a history of post-obstructive pneumonia (note: this
criterion does not exclude patients who have chronic obstructive pulmonary disease [COPD])
5. Patients with primary or metastatic lung cancer
6. Patients with cystic fibrosis, known or suspected Pneumocystis jiroveci pneumonia, or known or
suspected active tuberculosis
7. Patients who do not/ are not able to provide a urine sample (e.g., anuric) and a blood sample
