Community-acquired pneumonia caused by Streptococcus pneumoniae
Conditions
Interventions
In order to estimate the incidence of lower respiratory tract infection (LRTI) by respiratory syncytial virus (RSV) and pneumococcal community-acquired pneumonia (CAP), including CAP by V114 serotypes
E01.370.225.875.150.125.890
Sponsors
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Merck Sharp & Dohme Corp., uma subsidiária da Merck & Co., Inc.
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Aged 60 years old or older at enrollment; Hospitalized patient; Subject with clinical evidence of LRTI at hospital admission or up to 48 hours; Medical chart available for revision and data collection; Consent to take part in the study by signing the ICF. If the subject is not able to consent, formal consent should be collected by the legal responsible before study initiation
Exclusion criteria
Exclusion criteria: Enrolled in this study within the past 30 days; An individual can present multiple episodes of pneumonia (as a new infection), so he/she can be included multiple times in this study. Those who are re-admitted within 30 days from the previous hospitalization will be excluded, as it would probably be a complication of the initial episode of pneumonia. A re-hospitalization after 30 days of previous hospital discharge will be considered as a new pneumonia infection; Older adult patients with hospital-acquired infection or ventilator-associated infection; Transferred from another hospital or inpatient healthcare facility after already being hospitalized for 48h or more (in this case, it will be considered hospital-acquired infection); Development of LRTI more than 48 hours after hospital admission (if developed 48 hours after admission, it will be considered as hospital-acquired LRTI); Patients unable or unwilling to provide a urine samples within 48 hours of hospital admission (considering patients transferred from another hospital, this period include the time elapsed since the first hospital admission); Alternative illnesses that explain patient’s signs and symptoms, that excludes LRTI as primary diagnosis; Patient in use of antibiotics in the last 7 days before ICF signature; Patient who does not live in the same municipality as study site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Estimate the incidence of lower respiratory tract infection (ITRi) by respiratory syncytial virus (RSV) in hospitalized older adults. RSV infection will be detected by RT-PCR using samples from the lower respiratory tract collected for the study (nasopharyngeal swab - preferable, tracheal aspiration or bronchoalveolar lavage - for intubated patients, or under mechanical ventilation, or any other condition in which the collection of the swab cannot be obtained). The incidence will be expressed as the number of RSVs per 100,000 over 60 years old people, with 95% CI for both cumulative incidence and separate annual incidence for each calendar year. The incidence will also be estimated according to the aggregated epidemiological weeks (four weeks), that is, data from each four-week period will be used to perform the calculation;Expected outcome 2: Estimate the incidence of pneumococcal community-acquired pneumonia (CAP) in older patients hospitalized by the positive BinaxNow® test and / or with the detection of any serotype in the SSUAD test and / or pneumococcal culture resulting from pneumococci. The incidence will be expressed as the number of RSVs per 100,000 over 60 years old people, with 95% CI for both cumulative incidence and separate annual incidence for each calendar year | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 3: Estimate the general incidence and prevalence of pneumococcal CAP with the serotypes included in V114 in hospitalized elderly patients, which can be determined from the detection of the specific serotype by the SSUAD test. The incidence will be expressed as the number of RSVs per 100,000 over 60 years old people, with 95% CI for both cumulative incidence and separate annual incidence for each calendar year;Expected outcome 4: Describe the monthly hospitalization rate among the older patients caused by RSV, CAP and pneumococcal CAP during the study period. The monthly distribution of RSI, RSI, CAP and pneumococcal CAP cases will be expressed as the hospitalization rate, that is, the number of cases (such as RSV infection) according to all cases of hospitalization for ITRi in the study (study population ) a month. Preferably the distribution will be shown in graphs, with the seasons highlighted for better viewing;Expected outcome 5: Describe the proportion of RSV co-infection in older patients hospitalized with CAP and Pneumococcal CAP, and RSV infection will be detected by RT-PCR using samples from the lower respiratory tract collected for the study (nasopharyngeal swab - preferable, tracheal aspiration or bronchoalveolar lavage - for intubated patients, or under mechanical ventilation, or any other condition in which swab collection cannot be obtained). For the analysis of co-infections, we will estimate the proportion of RSV infection between the PAC cohort and between the subset of pneumococcal PAC. Therefore, the numerator will be, respectively, the number of positive RSV cases in the PAC cohort, and the number of positive RSV cases in the pneumococcal PAC subset. The denominator will be, respectively, the number of participants with CAP and the number of participants with confirmed pneumococcal CAP. In case of data imputation for RSV detection, we will conduct the analysis for the data set with and without data imputation;Expected outcome 6: | — |
Countries
Brazil
Contacts
Public ContactCícera Marcelino
Outcome results
None listed