Objective of the study is to quantify the microbiological etiology in immunocompromised patients, at least 18 years of age, with CAP needing hospitalization. And to determine the severity, antibiotic use and outcome of CAP in immunocompromised…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To quantify the microbiological etiology in immunocompromised patients, at
least 18 years of age, with CAP needing hospitalization.
Secondary outcome
To determine the severity, antibiotic use and outcome of CAP in
immunocompromised patients, at least 18 years of age, with CAP needing
hospitalization.
Background summary
In a previous observational study 23% of Community Acquired Pneumonia (CAP)
episodes among adults in the Netherlands were caused by pneumococci with
serotypes that are included in the 13-valent conjugate pneumococcal vaccine
(13v PnV). In the CAPiTA trial 84.500 healthy elderly have been randomized to
receive either 13v PnV or placebo, and the incidence of CAP needing
hospitalization and caused by any of the 13 vaccine serotypes is the primary
study endpoint. Yet, study participation was based on strict inclusion
criteria, intentionally creating selection of healthy elderly. Moreover, the
decision to participate among eligibles may also induce selection bias
(*healthy vaccinee effect*). Therefore, the study population may not be
considered generalizable for the whole population of elderly in the
Netherlands, and it is unknown to what extent the microbiological etiology of
the study population differs from other patient populations. This knowledge gap
may influence acceptance of the CAPiTA study results.
Study objective
Objective of the study is to quantify the microbiological etiology in
immunocompromised patients, at least 18 years of age, with CAP needing
hospitalization. And to determine the severity, antibiotic use and outcome of
CAP in immunocompromised patients, at least 18 years of age, with CAP needing
hospitalization.
Urine for the SSUAD test will be collected from immune-compromised patients
with NO suspicion of a respiratory infectious disease or other acute infectious
disease.
Study design
This is an observational study. Patient will be included based on the suspicion
fo CAP. The final diagnosis of CAP will be based on the presence of enough
clinical criteria and presence of an infiltrate on the chest X-ray. When there
is no more suspicion of CAP within 48 hours after admission, patient will not
be included. The final interpretation of the chest X-ray wil be done by
independent radiologists.
The microbiological etiology will be determined upon clinical cultures (blood,
sputum and pleural fluid if indicated), urinary antigen testing (BINAX for
pneumococci and Legionella when clinically indicated), virological examination
of throat swab and the SSUAD test for serotype specific pneumococcal antigen
identification. These diagnostic procedures are identical to the ones used for
CAPiTA patients, with the exception of collection of blood sample.
On presentation on the ER or within 24 hours after admission two study samples
will be taken: 1 pharyngeal swab and 1 urine sample, at least 5mL. Within 48
hours after admission the patient will be asked permission to use these samples
for diagnostic research. If no permission is obtained, the samples will be
destroyed. If the patient does give permission for participation in the trial
and thereby confirming use of the pharyngeal swab and urine sample, these
samples will be analyzed in a central laboratory.
Urine for the SSUAD test will be collected from immune-compromised patients
with NO suspicion of a respiratory infectious disease or other acute infectious
disease.
Study burden and risks
Burden: 1 pharyngeal swab is taken.
Risks: itchy feeling in the throat, coughing, feeling of throwing up.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
For the 1000 CAP patients:
Immunocompromised patients, aged 18 years or older with suspicion of CAP defined as the presence of at least two of the following symptoms: fever/ hypothermia, cough, sputum production, dyspnea/ tachypnea/ hypoxia, percussion/ auscultatory findings consistent with pneumonia, leucocytosis/ leukopenia/ left shift or new infiltrate on chest X-ray. ;For the 400 controls:
Adults (18 years or older) with an immune-compromising condition, and able to provide urine.
Exclusion criteria
For the 1000 CAP patients:
- Patients with recent hospitalization (<2 weeks)/ residing in long-term care facilities.
- CAPiTA participants.;For the 400 controls:
- Subjects with suspicion of CAP or other respiratory infectious diseases, as well as evidence of or documented concomitant infectious disease within 14 days of the day of inclusion.
- Subjects with fever (measured temperature of *38.0°C measured by a healthcare provider).
- Subjects residing in any long-term care facilities (for example, nursing homes, respite care facilities, etc.).
- Subjects with either pneumococcal conjugate vaccine (PCV) and/or pneumococcal polysaccharide vaccine (PPV) administration within the past 30 days.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL32513.041.10 |