Aims: 1. To optimize the diagnosis of M. pneumoniae infections by discriminating between colonization and symptomatic infection using quantitative PCR. 2. To study the role of host factors (age, and bacterial and viral co-infection) on infection by…
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this explorative study, M. pneumoniae will be quantified in nose- and throat
swabs/aspirates of children aged 0-16 years with mild to severe symptoms of
respiratory tract infection, and in a control group consisting of children
without respiratory tract infection. The quantity of M. pneumoniae (in
copies/ml or copies/swab) will be related to clinical disease in order to
differentiate asymptomatic carriership from infection. To investigate the role
of co-colonization or -infection, the presence of other bacteria or viruses in
the respiratory tract will be analyzed as well. To study the age distribution
in relation to M. pneumoniae infection, a precalculated number of patients of
either < 5 or >= 5 years of age will be included. Genotyping of M. pneumoniae
will be performed, and related to severity of disease and/or colonization.
Prevalence of colonization and/or infection with M. pneumoniae will be
calculated.
Secondary outcome
Not applicable
Background summary
Background: 150 million children/year suffer from pneumonia worldwide, and 20
million children have to be hospitalized for this reason. Up to 40% of
community-acquired pneumonias are caused by Mycoplasma pneumoniae and as many
as 34% of cases requiring hospitalization in children. Studies using the
recently introduced PCR suggest that M. pneumoniae frequently causes
respiratory tract infections (RTI), not only in older children as previously
thought, but also in children younger than 5 years. This is important because
M. pneumoniae is not sensitive to the first choice β-lactam antibiotics.
Moreover, it is unknown whether the detection of M. pneumoniae by PCR also
confirms this pathogen as the cause of the infection. A limited number of
studies suggest that an asymptomatic carrier state exists. Due to the
shortcomings in diagnosis, knowledge on the role of different host and
bacterial factors on progression to infection is very limited.
Hypothesis
M. pneumoniae is capable of asymptomatic colonization, which can be
differentiated from infection by quantitative PCR. M. pneumoniae causes RTI*s
in children younger than 5 years as frequently as in older children. The
genetic background of M. pneumoniae strains as well as viral co-infections
influence progression from colonization to infection.
Study objective
Aims:
1. To optimize the diagnosis of M. pneumoniae infections by discriminating
between colonization and symptomatic infection using quantitative PCR.
2. To study the role of host factors (age, and bacterial and viral
co-infection) on infection by M. pneumoniae.
3. To investigate the relationship between M. pneumoniae genotype and
virulence.
Study design
Methods: In healthy children and children visiting the emergency department
because of an RTI, clinical data, nasal and pharyngeal swab and nasal washing
will be collected. Bacterial and viral causes of respiratory tract infections
will be analyzed.
RTI by M. pneumoniae will be defined by RTI symptoms in combination with
serology and/or culture positive for M. pneumoniae.
Study burden and risks
not applicable
dr Molewaterplein 60
3015 GJ Rotterdam
NL
dr Molewaterplein 60
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Group A
· Age: ³3 months and <= 16 years
· Clinical signs and symptoms of community-acquired upper or lower respiratory tract infection (i.e. cough, rhinitis, sore throat, wheezing and fever).
· Written informed consent;Group B (control group)
· Age: ³3 months and <= 16 years
· Written informed consent
· Healthy controls: absence for ³1 week of clinical signs and symptoms of community-acquired upper or lower respiratory tract infection (i.e. cough, rhinitis, sore throat, wheezing and fever)
Exclusion criteria
Severe concomitant disease (chronic lung disease, neoplasia, liver or kidney disease, immunodeficiency, cardiovascular disease, psychomotor impairment). Nosocomial infection. Use of antibiotics in the 48 hours that preceded enrollment or azithromycin within 1 week before enrollment
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 | NL20418.078.08 |