The primary objective of the REBEL study is to collect data needed to design control policies to diminish the spread of ESBL-producing Gram negative bacteria in the Dutch population.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
dragerschap van ESBL-producerende bacteriën
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
According to the first part of the observational study we aim to include 2000
to 3000 patients. The main study parameter is the enrollment of 2000 to 3000
patients which filled in an informed consent, completed the questionnaire and
returned a rectal swab or faecal sample. Also 550 participants attending the
GGD will be asked to participate.
According to the second part of the observational study we aim to include 50
patients carrying ESBL-producing strains. The main study parameter of this part
is the enrollment of these 50 patients accompanied with the participation of
the household members as many as possible.
Secondary outcome
After follow-up of the first fifty patients and their household members we will
compare these human strains with animal strains but an evident endpoint is not
applicable.
Background summary
Resistance to beta-lactam antibiotics (penicillins and cephalosporins) due to
extended-spectrum beta-lactamases (ESBLs) is emerging explosively over the
world. This resistance is becoming a major public health problem, since
ESBL-producing bacteria are found in hospitals, in long term care facilities,
in the community, and in food-producing animals. The association of ESBL
production with resistance to several other classes of antibiotics is
particularly threatening. Data from EARSS (European Antibiotic Resistance
Surveillance Study) and from a national survey (ONE study) show that the rapid
increase in resistance due to ESBLs is also occurring in The Netherlands. The
precise size of the problem, the determinants of the increase in resistance,
and the risk factors for the occurrence of ESBL-producing microorganisms in The
Netherlands, however, are largely unknown.
An estimate of the size of the problem can be obtained by the prevalence of
colonization with ESBL-producing bacteria among patients who visit their
general practitioner. Molecular characterization of the ESBL genes, and of the
mobile genetic elements and strains carrying these genes, permits to determine
whether resistant strains and resistance genes persist in colonized persons,
whether spread to household members occurs, and whether related ESBL genes are
found in Enterobacteriaceae in food-producing animals.
Study objective
The primary objective of the REBEL study is to collect data needed to design
control policies to diminish the spread of ESBL-producing Gram negative
bacteria in the Dutch population.
Study design
An observational study consisting of two parts and a case control study will be
performed at the VUmc in collaboration with the AGPN and the GGD Amsterdam.
Study burden and risks
Patients will be asked to submit a rectal swab specimen or a faecal sample and
to fill in a short questionnaire. No interventions will be done. No risks are
associated with participation and the burden is minimal. In order to give a
good representation of carriage on household members we aim to include minors
or mental incompetent people as well in part 2 of the observational study. This
part of the study will give better results and therefore better implications
using also these patient groups.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Observational study part 1: consecutive patients attending general practices or belonging to the outpatients population/primary care population, all patients aged 18 years or older and mentally competent.
Observational study part 2 (in combination with the GGD): also patients < 18 years.
Exclusion criteria
Observational study part 1: age younger than 18 years and mentally incompetent; For approaching patients by postal mail (using the patient file of the GP), GPs will exclude patients who are terminally ill or otherwise not properly approachable. GPs will go through the database of the patient file and sort them out personally.
Observational study part 2: mental incompetent patients.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL29769.029.09 |
| Other | TC = 2453 |
| OMON | NL-OMON23069 |