Environmental Contamination of ESBL, Infection Due to ESBL Bacteria, Urinary Tract Infection
Conditions
Keywords
Urinary tract infection, ESBL, treatment, carriage, risk factors, water contamination
Brief summary
This project aims at investigating the duration of human fecal carriage of bacteria harboring plasmid-borne resistance genes expressing Extended Spectrum beta-lactamases (ESBL), risk factors for infections with such bacteria and persistence, mobility and spread of ESBL in the environment and within households. It also aims to compare different methods of detecting ESBL carriage and treat patients with urinary tract infection caused by these bacteria.
Interventions
None listed
Sponsors
Helse Sor-Ost
University Hospital of North Norway
University of Oslo
Vestre Viken Hospital Trust
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>=18 of age with a urine culture yielding E. coli or K. pneumoniae \>10.000 colony forming units/mL.
Exclusion criteria
* Patients who have lived in Norway for \<1 year * Patients who are unable to answer a questionaire * Patients who have been infected with an ESBL producing bacteria before * Patients who have been admitted to a hospital or a long term care facility for \>24 hours during the past 31 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure | 14 days after initiation of treatment | Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Outcome | 14 days | A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Carriage of ESBL Producing Bacteria | up to 3 years | Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined. |
Participant flow
Recruitment details
Patients with any type of CA-UTI caused by ESBL-producing or non-ESBL producing E. coli and receiving empirical treatment were included in the study. Data on treatment outcome were obtained and possible associations between outcome and mecillinam treatment, ESBL-status and other variables were investigated.
Participants by arm
| Arm | Count |
|---|---|
| Patients With UTI Caused by Extended-spectrum β-lactamase-prod Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli | 81 |
| Patients With UTI Caused by Non-ESBL-producing E. Coli Patients with UTI caused by non-ESBL-producing E. coli | 262 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligible | 166 | 191 |
Baseline characteristics
| Characteristic | Patients With UTI Caused by Extended-spectrum β-lactamase-prod | Patients With UTI Caused by Non-ESBL-producing E. Coli | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 61 years | 59 years |
| Region of Enrollment Norway | 81 participants | 262 participants | 343 participants |
| Sex: Female, Male Female | 75 Participants | 225 Participants | 300 Participants |
| Sex: Female, Male Male | 6 Participants | 37 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 262 |
| serious Total, serious adverse events | 0 / 81 | 0 / 262 |
Outcome results
Primary
Treatment Failure
Patients included in the study with urinary tract infection (UTI) and treated as part of normal routine were followed for 14 days and further prescriptions of antimicrobials normally used for treatment of UTI will be considered treatment failures. Only participants that received pivmecillinam are reported here. In the paper published in PlosOne High Rate of Per Oral Mecillinam Treatment Failure in Community-Acquired Urinary Tract Infections Caused by ESBL-Producing Escherichia coli the mecillinam treatment group were compared with the group that did not receive mecillinam.
Time frame: 14 days after initiation of treatment
Population: Patients that did receice pivmecillinam.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With UTI Caused by Extended-spectrum β-lactamase-prod | Treatment Failure | 23 Treatment success |
| Patients With UTI Caused by Non-ESBL-producing E. Coli | Treatment Failure | 101 Treatment success |
Secondary
Subjective Outcome
A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.
Time frame: 14 days
Other Pre-specified
Carriage of ESBL Producing Bacteria
Culture results from patient fecal samples will be collected up to 3 years after urinary tract infection and carriage of ESBL producing bacteria will be examined.
Time frame: up to 3 years