Clinical trial • Phase IV • Infectious Disease

Amoxicillin; Clavulanic acid for Urinary tract infection caused by ESBL-producing Enterobacterales | Bacteremia caused by ESBL-producing Enterobacterales

Phase IV trial of Amoxicillin; Clavulanic acid for Urinary tract infection caused by ESBL-producing Enterobacterales | Bacteremia caused by ESBL-producing…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Urinary tract infection caused by ESBL-producing Enterobacterales | Bacteremia caused by ESBL-producing Enterobacterales
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
28-10-2024

Trial design

Ertapenem Fresenius Kabi 1 g (solution for infusion, intravenous) ; Ciprofloxacin Orion 500 mg (film-coated tablet, oral) ; Eusaprim forte 160 mg/800 mg (sulfamethoxazole/trimethoprim tablet, oral). Doses are provided in product names; no trial-specific schedule or administration schedule described in the available data.-controlled Phase IV trial across 21 sites in Sweden.

Comparator
Ertapenem Fresenius Kabi 1 g (solution for infusion, intravenous) ; Ciprofloxacin Orion 500 mg (film-coated tablet, oral) ; Eusaprim forte 160 mg/800 mg (sulfamethoxazole/trimethoprim tablet, oral). Doses are provided in product names; no trial-specific schedule or administration schedule described in the available data.
Target Sample Size
330
Trial Duration For Participant
28

Eligibility

Recruits 330 No vulnerable populations selected; informed consent is signed by the patient (Informed consent is signed by patient). No assent or paediatric consent procedures described..

Pregnancy Exclusion
Pregnancy
Vulnerable Population
No vulnerable populations selected; informed consent is signed by the patient (Informed consent is signed by patient). No assent or paediatric consent procedures described.

Inclusion criteria

  • {"criterion_text":"- Adult men and women (> 18 years) with urine and/or blood culture positive for EPE. Thus, intravenous antibiotics must have been started for patients to be included.\n- Patient has received in patient care with 1-5 days of intravenous treatment with empirical antibiotics. The treating physician has considered per oral treatment safe.\n- Fever (≥ 38.0 C at least once at home or at hospital) at the emergency room (ER). Per oral therapy can be initiated regardless of temperature.\n- Clinical suspicion of UTI at the ER. The latter is suspected due to at least one of the following symptoms: flank pain, dysuria, positive dipstick analysis, or percussion tenderness over kidneys.\n- Informed consent is signed by patient.\n- Discontinuing parenteral treatment and starting treatment with per oral antibiotics is considered safe according to treating physician."}

Exclusion criteria

  • {"criterion_text":"- Known/suspected beta-lactam allergy.\n- Clinical isolate of EPE is pivmecillinam-resistant\n- Pregnancy\n- Other reason, according to treating physician, to which patient is unfit to be included in the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Clinical response 7 to 10 days (test of cure, TOC) after antibiotic treatment has been discontinued. The primary endpoint is met if the patient has no symptoms (i.e. resolution of fever and dysuria > 24 h) and no further antibiotic treatment is necessary, as determined by treating physician.","definition_or_measurement_approach":"Assessed at test of cure (TOC) 7–10 days after antibiotic discontinuation; primary endpoint met if patient has no symptoms (resolution of fever and dysuria >24 h) and no further antibiotic treatment is necessary, as determined by the treating physician."}

Secondary endpoints

  • {"endpoint_text":"- Growth of EPE in follow up urine culture (microbiological endpoint) at TOC.","definition_or_measurement_approach":"Microbiological culture of urine at test of cure (TOC) to detect growth of ESBL-producing Enterobacterales."}
  • {"endpoint_text":"- Faecal culture positive for EPE at follow up at TOC.","definition_or_measurement_approach":"Faecal culture at TOC to detect carriage of ESBL-producing Enterobacterales."}
  • {"endpoint_text":"- Death from all causes within 28 days.","definition_or_measurement_approach":"All-cause mortality assessed up to 28 days after inclusion."}

Recruitment

Planned Sample Size
330
Recruitment Window Months
44
Consent Approach
Informed consent is signed by the patient. Subject information and informed consent form documented (L1_SIS and ICF). No assent or paediatric consent described; no languages specified in available documents.

Geography

Total Number Of Sites
21
Total Number Of Participants
330

Sweden

Earliest CTIS Part Ii Submission Date
02-04-2024
Latest Decision Or Authorization Date
28-10-2024
Processing Time Days
209
Number Of Sites
21
Number Of Participants
330

Sites

Site Name
Region Gaevleborg
Department Name
Gävle sjukhus, Infektion, Lasarettsvägen 1, 801 88 Gävle
Contact Person Name
Lena-Maria Söder
Site Name
Laenssjukhuset I Kalmar Region Kalmar Laen
Department Name
Infektionsmottagning
Contact Person Name
Viktoria Järneström Norberg
Site Name
Malarsjukhuset Eskilstuna
Department Name
Infektion, Entré 11, Björnströmsgatan 6, Mälarsjukhuset Eskilstuna
Contact Person Name
Joakim Lundvik
Site Name
Region Vaermland
Department Name
Infektionskliniken, Centralsjukhuset Karlstad
Contact Person Name
Anna Wimmerstedt
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO Infektion, Hälsogatan 3, SUS, 221 85 Lund
Contact Person Name
Christian Kampmann
Contact Person Email
christian.kampmann@skane.se
Site Name
Region Vaestmanland
Department Name
Infektionsenheten, Sigtunagatan, Västmanlands sjukhus Västerås
Contact Person Name
Emeli Månsson
Site Name
Region Skane Helsingborg Hospital
Department Name
Infektionsenheten, Charlotta Yhléns gata 10, Helsingborg
Contact Person Name
Oskar Ljungquist
Contact Person Email
Oskar.ljungquist@med.lu.se
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
VO infektion, Ruth Lundskogs gata 3, Malmö
Contact Person Name
Johan Tham
Contact Person Email
johan.tham@med.lu.se
Site Name
Region Jaemtland Haerjedalen
Department Name
Östersunds sjukhus, Kyrkgatan 12, 831 50 Östersund, Infektionskliniken
Contact Person Name
Elin Hedman
Contact Person Email
elin.hedman@regionjh.se
Site Name
Region Skane Kristianstad Central Hospital
Department Name
VO Infektion, Infektionsmottagning, Ambulansvägen 4, 29185 Kristianstad
Contact Person Name
Emil Thiman
Contact Person Email
Emil.Thiman@skane.se
Site Name
Capio S:t Goerans Sjukhus AB
Department Name
Infektion, S:t Göransplan 1, Stockholm
Contact Person Name
Anna Hallgren
Contact Person Email
Anna.Hallgren@capiostgoran.se
Site Name
Region Gotland
Department Name
Infektion, Visby lasarett
Contact Person Name
Jonas Lindell
Contact Person Email
Jonas.lindell@gotland.se
Site Name
Sodra Alvsborg Hospital Vastra Gotalandsregionen
Department Name
Infektionsenheten, Södra Älvsborgs sjukhus, Samaritvägen 1, Borås
Contact Person Name
Maria C. Lindh
Contact Person Email
maria.c.lindh@vgregion.se
Site Name
Skaraborg Hospital-Vastra Gotalandsregionen
Department Name
Infektionsmottagning, Lövängsvägen 10, Skövde
Contact Person Name
Elin Edman-Haglind
Contact Person Email
elin.edman@vgregion.se
Site Name
Region Halland
Department Name
Infektion, Hallands Sjukhus Halmstad, 30185 Halmstad
Contact Person Name
Jacob Söderlind
Site Name
Region Norrbotten
Department Name
Infektionskliniken, Sunderby sjukhus, Sjukhusvägen 10, 971 80 Luleå
Contact Person Name
Tomas Gustafsson
Contact Person Email
tomas.gustafsson@umu.se
Site Name
Region Oestergoetland
Department Name
Infektionskliniken i Östergötland
Contact Person Name
Åse Östholm
Site Name
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Department Name
Infektionskliniken i Östergötland
Contact Person Name
Vidar Möller
Site Name
Region Vaesternorrland
Department Name
Sundsvalls sjukhus, Lasarettsvägen 21, 856 43 Sundsvall, Infektionskliniken
Contact Person Name
Johanna Repo
Contact Person Email
johanna.repo@rvn.se
Site Name
NU Hospital Group-Vaestra Goetalandsregionen (Uddevalla Sjukhus / NÄL)
Department Name
Uddevalla Sjukhus, Infektionskliniken / Infektionskliniken, NÄL
Contact Person Name
Johanna Karlsson / Hanna Norlin Arnell

Sponsor

Primary sponsor

Full Name
Region Skane
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Third parties

  • {"country":"Sweden","full_name":"Region Skane Skanes Universitetssjukhus","duties_or_roles":"sponsorDuties codes: 1, 6","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Amoxicillin/Clavulanic acid Aurobindo 500 mg/125 mg filmdragerade tabletter
Active Substance
Amoxicillin; Clavulanic acid
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number: 42590)
Maximum Dose
1500 mg per day
Investigational Product Name
Ciprofloxacin Orion 500 mg filmdragerade tabletter
Active Substance
Ciprofloxacin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number: 23576)
Maximum Dose
1000 mg per day
Investigational Product Name
Eusaprim forte 160 mg/800 mg tabletter
Active Substance
Sulfamethoxazole; Trimethoprim
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number: 9263)
Maximum Dose
1600 mg per day
Investigational Product Name
Ertapenem Fresenius Kabi 1 g pulver till koncentrat till infusionsvätska, lösning
Active Substance
Ertapenem
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketing authorisation number: 33989)
Maximum Dose
1 g per day
Investigational Product Name
Selexid 400 mg filmdragerade tabletter
Active Substance
Pivmecillinam hydrochloride
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number: 43371)
Maximum Dose
1200 mg per day
Combination Treatment
Yes

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