Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
548
Countries
1
Sites
3
urinary tract infections
To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice
Key facts
- Sponsor
- Azienda Ospedaliero Universitaria Di Modena
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 12 Nov 2024 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Italian Ministry of Health
External identifiers
- EU CT number
- 2024-516591-15-00
- EudraCT number
- 2023-000052-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice
Secondary objectives 1
- i) to describe the MIC distribution of isolates against all the study drugs by gold standard methods (i.e. agar dilution for fosfomycin and broth microdilution for alternative drugs) and investigate their correlation with clinical outcome; ii) to describe the main mechanisms of cephalosporin resistance in the isolates obtained from the blood cultures of patients with bacteremic cUTI by whole genome sequencing (WGS) and analyze their correlation with clinical outcome iii) to investigate the impact of PK/PD target attainment with clinical outcome; iv) to evaluate changes in the gut microbiota in patients with cUTIs and to compare the impact of each type of antibiotic therapy on the gut microbiota. Fecal microbial DNA will be extracted and subsequently analyzed by sequencing of the V3-V4 regions of the 16S ribosomal RNA gene.
Conditions and MedDRA coding
urinary tract infections
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10046849 | UTI symptoms | 10021881 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- cUTI, in adult patients, defined as the presence of signs or symptoms, pyuria, and growth of cephalosporin-non-susceptible, fosfomycin susceptible Enterobacterales in urine (a positive urine culture of 105 colony-forming units (CFU)/ml).
Exclusion criteria 1
- Hemodynamical instability in the last 24 hours - Alternative source of infection explaining the fever according to physician’s judgement - Prostatitis, orchitis, or epididymitis - Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy prior to EOT) - pregnancy and/or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)
Secondary endpoints 1
- Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP10319265 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 18 g gram(s)
- Max total dose
- 18 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX01 — FOSFOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
SCP1153878 · ATC
- Active substance
- Tazobactam Sodium
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 18 g gram(s)
- Max total dose
- 18 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP109549648 · ATC
- Active substance
- Ertapenem Sodium
- Substance synonyms
- ERTAPENEM MONOSODIUM
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH03 — ERTAPENEM
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero Universitaria Di Modena
- Sponsor organisation
- Azienda Ospedaliero Universitaria Di Modena
- Address
- Largo Del Pozzo 71
- City
- Modena
- Postcode
- 41124
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero Universitaria Di Modena
- Contact name
- Marianna Meschiari
Public contact point
- Organisation
- Azienda Ospedaliero Universitaria Di Modena
- Contact name
- Marianna Meschiari
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 548 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero Universitaria Di Modena
Medicine Specialistiche, Largo Del Pozzo 71, 41124, Modena
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Gestione Integrata del Rischio Infettivo/U.O. Malattie Infettive, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Medicina Clinica e Chirurgia, Malattie Infettive, Via Sergio Pansini 5, 80131, Naples
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2024-11-12 | 2024-11-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516591-15-00 | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ertapenem | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ertapenem | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ertapenem 1 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC fosfomicina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Piperacillina e Tazobactam | 1 |
| Synopsis of the protocol (for publication) | D1_protocol synopsis IT 2024-516591-15-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Italy | Acceptable 2024-11-07
|
2024-11-12 |