TEMO-BLSE: Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae

• Sponsor: Centre Hospitalier Annecy Genevois (Other)
• Overall Status: Completed
• CT.gov ID: NCT04671290
• Collaborator: APHP (Other), Sorbonne University (Other), Hopitaux Civils de Colmar (Other), Hopital Foch (Other), CH Annecy Genevois (Other)
• Enrollment: 144
• Actual Duration (Months): 58

Study Details

Study Description

Brief Summary

To assess the efficacy of temocillin compared to carbapenems for the management of ESBL-E UTI.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection Bacterial	Other: Any intervention

Detailed Description

Adults with a definite diagnosis of ESBL-E UTI between January-2015 and October-2019 were enrolled in a multicenter retrospective case-control study. Cases were treated with temocillin ≥50% of the effective antibiotic therapy duration. Control exclusively received carbapenem over the effective antibiotic therapy duration.

Study Design

• Study Type: Observational
• Actual Enrollment: 144 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae: a Multicenter Case-control Study.
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Oct 31, 2019
• Actual Study Completion Date: Oct 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Control Carbapenem (imipenem, or meropenem, or ertapenem) as first-line therapy or after receiving up to 72 hours of other antibiotics (including aminoglycosides).	Other: Any intervention; No intervention
Cases Temocillin above 50% of the time of effective antibiotic therapy duration. Temocillin had to be given as first-line therapy or after receiving a maximum of 5 days of other antibiotics (including carbapenems and aminoglycosides).	Other: Any intervention; No intervention

Outcome Measures

Primary Outcome Measures

1. Rate of clinical cure [Day 14 (End of antibiotic treatment according to national recommendations)]

   Number of patient in clinical cure is defined as the resolution of fever and symptoms of UTI present at antibiotic initiation (and no new symptoms) and the absence of clinical or microbiological failure.

Secondary Outcome Measures

1. Kinetic of fever defervescence [Baseline (day 0), day 3, day 7, day 14]

   Median fever calculation

2. Inflammatory biomarkers [Baseline (day 0), day 3, day 7, day 14]

   White blood cells (WBC) count (/mm3)

3. Inflammatory biomarkers [Baseline (day 0), day 3, day 7, day 14]

   CRP level (mg/l)

4. Length of hospital stay [3 months after UTI diagnosis]

   Mean duration of hospital stay

5. Relapse of UTI [3 months after antibiotic therapy initiation]

   Number of patient with a new UTI diagnosis after the end of antibiotic treatment

6. Loss to follow-up, re-hospitalization, and mortality (safety endpoints) [3 months after antibiotic therapy initiation]

   Number of loss to follow-up, re-hospitalization, and mortality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults

• Diagnosis of UTI defined by at least two of the following symptoms :chills,temperature

38°C (fever), flank or pelvic pain, nausea or vomiting, dysuria, urinary frequency, or urinary urgency, costovertebral angle tenderness on physical examination

• Positive urine culture with ≥ 103 CFU/mL of a single strain of ESBL-E

• Confirmed ESBL-producing enterobacteriaceae (ESBL-E) susceptible to carbapenems

Exclusion Criteria:

• Multibacterial infection

• Opposition to data collection according to GDPR

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Centre Hospitalier Annecy Genevois
• APHP
• Sorbonne University
• Hopitaux Civils de Colmar
• Hopital Foch
• CH Annecy Genevois

Investigators

• Principal Investigator: Mathieu LAFAURIE, M.D, APHP, St Louis Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Annecy Genevois
• ClinicalTrials.gov Identifier: NCT04671290
• Other Study ID Numbers: 19-10
• First Posted: Dec 17, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Bacterial Infections

Study Results

No Results Posted as of Dec 17, 2020