Overview
Sponsor-declared trial summary
Uncomplicated urinary tract infection (uUTI)
To assess that the efficacy of fosfomycin calcium in the clinical and microbiological resolution of the uUTI in womwn is non-inferior to the efficacy of fosfomycin trometamol
Key facts
- Sponsor
- Asociacion Instituto De Investigacion Sanitaria Bioaraba, Laboratorios Ern S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518646-24-00
- EudraCT number
- 2021-002911-72
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess that the efficacy of fosfomycin calcium in the clinical and microbiological resolution of the uUTI in womwn is non-inferior to the efficacy of fosfomycin trometamol
Secondary objectives 1
- To monitor the safety and tolerability of the dose regimen of oral fosfomycin calcium capsules when administered in adult women with uUTI
Conditions and MedDRA coding
Uncomplicated urinary tract infection (uUTI)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Adult women (>= 18 years) (with initial uUTI)
- Must have >= two of the following signs of uUTI:urinary frecuency, urinary urgency, sysuria (pain of burning on urination) and/ or suprapubic pain.
- Mid-stream urine specimen with dipstick analysispositive for at least leukocyte estearase (evidence of pyuria).
- Women of childbearing potential (following menarche and until becoming post- menopausal unless permanently sterile) must use effective birth control methods recommended by Clinical Trial Facilitation Group (CTFG)
- Subject able to communicate effectevely and provide written informed consent
Exclusion criteria 6
- Clinical evidence of renal pathology (renal impairment, fever and renal first percussion positive)
- Patients with history of hipersensitivity to fosfomycin or to any of the excipients contained in the drug formulation
- Patients with galactose intolerance, with glucose-galactose malabsorption or with insufficiency of sucrase isomaltase
- Women with gynaecological infections and cUTI
- Pregnant or nursing woman
- Taking part in another clinical trial during the two months prior to the current trial
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Clinical (resolution of symptoms of uUTI) and microbiological response (bacterial pathogen reduced to <1000 CFU/mL in urine culture) in the microbiological -ITT population obtained at TOC VISIT
Secondary endpoints 1
- Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP10319265 · ATC
- Active substance
- Fosfomycin Calcium
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX01 — FOSFOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asociacion Instituto De Investigacion Sanitaria Bioaraba
- Sponsor organisation
- Asociacion Instituto De Investigacion Sanitaria Bioaraba
- Address
- Jose Achotegui Kalea S/n 4º C
- City
- Vitoria
- Postcode
- 01009
- Country
- Spain
Scientific contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Bioaraba
- Contact name
- María Cabero
Public contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Bioaraba
- Contact name
- María Cabero
Laboratorios Ern S.A.
- Sponsor organisation
- Laboratorios Ern S.A.
- Address
- Calle De Peru 228
- City
- Barcelona
- Postcode
- 08020
- Country
- Spain
Sponsor responsibilities
- Contact point sponsor
- Asociacion Instituto De Investigacion Sanitaria Bioaraba
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 384 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol | 1 |
| Recruitment arrangements (for publication) | Doc1 | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-20 | Spain | Acceptable 2024-12-16
|
2024-12-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-25 | Spain | Acceptable | 2025-06-13 |