Trial Outcomes & Findings for Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients (NCT NCT01838213)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

760 participants

Primary outcome timeframe

14 days after initiation of treatment

Results posted on

2015-11-23

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Patients With UTI Caused by Extended-spectrum β-lactamase-prod Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli	Patients With UTI Caused by Non-ESBL-producing E. Coli Patients with UTI caused by non-ESBL-producing E. coli
Overall Study STARTED	247	453
Overall Study COMPLETED	81	262
Overall Study NOT COMPLETED	166	191

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With UTI Caused by Extended-spectrum β-lactamase-prod Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli	Patients With UTI Caused by Non-ESBL-producing E. Coli Patients with UTI caused by non-ESBL-producing E. coli
Overall Study Ineligible	166	191

Baseline Characteristics

Extended Spectrum Betalactamase Producing Bacteria; Epidemiology and Treatment in Non-hospitalized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With UTI Caused by Extended-spectrum β-lactamase-prod n=81 Participants Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli	Patients With UTI Caused by Non-ESBL-producing E. Coli n=262 Participants Patients with UTI caused by non-ESBL-producing E. coli	Total n=343 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	61 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	225 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	37 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment Norway	81 participants n=5 Participants	262 participants n=7 Participants	343 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days after initiation of treatment

Population: Patients that did receice pivmecillinam.

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.

Outcome measures

Outcome measures
Measure	Patients With UTI Caused by Extended-spectrum β-lactamase-prod n=41 Participants Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli	Patients With UTI Caused by Non-ESBL-producing E. Coli n=117 Participants Patients with UTI caused by non-ESBL-producing E. coli
Treatment Failure	23 Treatment success	101 Treatment success

SECONDARY outcome

Timeframe: 14 days

A patient form will be filled in. Data about cessation of symptoms of urinary tract infection will be recorded.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Patients With UTI Caused by Extended-spectrum β-lactamase-prod

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With UTI Caused by Non-ESBL-producing E. Coli

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arne Søraas, PhD

Vestre Viken Hospital Trust

Phone: +4790652904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place