REsistance to BEta-Lactam antibiotics due to extended-spectrum beta-lactamases in the Netherlands

Completed

Conditions: dragerschap van ESBL-producerende bacteriën
carriage with ESBL-producing bacteria
carriage of resistant bacteria

Registration Number: NL-OMON36316

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2700

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>According to the first part of the observational study we aim to include 2000<br /><br>to 3000 patients. The main study parameter is the enrollment of 2000 to 3000<br /><br>patients which filled in an informed consent, completed the questionnaire and<br /><br>returned a rectal swab or faecal sample. Also 550 participants attending the<br /><br>GGD will be asked to participate.<br /><br><br /><br>According to the second part of the observational study we aim to include 50<br /><br>patients carrying ESBL-producing strains. The main study parameter of this part<br /><br>is the enrollment of these 50 patients accompanied with the participation of<br /><br>the household members as many as possible.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>After follow-up of the first fifty patients and their household members we will<br /><br>compare these human strains with animal strains but an evident endpoint is not<br /><br>applicable.</p><br>