Clinical trial • Phase IV • Infectious Disease

FOSFOMYCIN CALCIUM for Uncomplicated urinary tract infection

Phase IV trial of FOSFOMYCIN CALCIUM for Uncomplicated urinary tract infection.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Uncomplicated urinary tract infection
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-11-2024
First CTIS Authorization Date
16-12-2024

Trial design

Randomised, fosfomycin trometamol (comparator treatment mentioned in main objective; dose and schedule not specified in available documents)-controlled Phase IV trial across 1 site in Spain.

Randomised
Yes
Comparator
fosfomycin trometamol (comparator treatment mentioned in main objective; dose and schedule not specified in available documents)
Target Sample Size
384
Trial Duration For Participant
3

Eligibility

Recruits 384 No vulnerable population selected; subjects must be able to communicate effectively and provide written informed consent (inclusion criterion: "Subject able to communicate effectevely and provide written informed consent"). No assent procedures specified; only adults (>=18 years) are eligible..

Pregnancy Exclusion
Pregnant or nursing woman
Vulnerable Population
No vulnerable population selected; subjects must be able to communicate effectively and provide written informed consent (inclusion criterion: "Subject able to communicate effectevely and provide written informed consent"). No assent procedures specified; only adults (>=18 years) are eligible.

Inclusion criteria

  • {"criterion_text":"- Adult women (>= 18 years) (with initial uUTI)"}
  • {"criterion_text":"- Must have >= two of the following signs of uUTI:urinary frecuency, urinary urgency, sysuria (pain of burning on urination) and/ or suprapubic pain."}
  • {"criterion_text":"- Mid-stream urine specimen with dipstick analysispositive for at least leukocyte estearase (evidence of pyuria)."}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Subject able to communicate effectevely and provide written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Clinical evidence of renal pathology (renal impairment, fever and renal first percussion positive)"}
  • {"criterion_text":"- Patients with history of hipersensitivity to fosfomycin or to any of the excipients contained in the drug formulation"}
  • {"criterion_text":"- Patients with galactose intolerance, with glucose-galactose malabsorption or with insufficiency of sucrase isomaltase"}
  • {"criterion_text":"- Women with gynaecological infections and cUTI"}
  • {"criterion_text":"- Pregnant or nursing woman"}
  • {"criterion_text":"- Taking part in another clinical trial during the two months prior to the current trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured in the microbiological-ITT population at the Test Of Cure (TOC) visit; microbiological response defined as bacterial pathogen reduced to <1000 CFU/mL in urine culture; clinical response defined as resolution of uUTI symptoms."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of subjects with continued clinical and microbiologic success assessed at Visit 1 (TOC visit)","definition_or_measurement_approach":"Proportion of subjects meeting continued clinical and microbiologic success at Visit 1 (TOC visit); assessed as a binary outcome at that visit."}

Recruitment

Planned Sample Size
384
Recruitment Window Months
31
Consent Approach
Written informed consent is required from subjects able to communicate effectively (inclusion criterion: "Subject able to communicate effectevely and provide written informed consent"). Only adults (>=18 years) are eligible, so no assent from minors. Subject information and informed consent form documents are listed (L1_ICF, L1_SIS); primary language appears to be Spanish (translations present for public title in Spanish).

Geography

Total Number Of Sites
1
Total Number Of Participants
384

Spain

Earliest CTIS Part Ii Submission Date
11-12-2024
Latest Decision Or Authorization Date
13-06-2025
Processing Time Days
184
Number Of Sites
1
Number Of Participants
384

Sites

Site Name
Hospital Universitario Araba
Department Name
Unidad de Ensayos clínicos
Principal Investigator Name
Mario Ernesto Jimenez
Principal Investigator Email
marioernesto.jimenezmercado@osakidetza.eus
Contact Person Name
Mario Ernesto Jimenez
Number Of Participants
384

Sponsor

Primary sponsor

Full Name
Asociacion Instituto De Investigacion Sanitaria Bioaraba
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Third parties

  • {"country":"Spain","full_name":"Laboratorios Ern S.A.","duties_or_roles":"legislationComplianceResp; article77ComplianceResp","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Laboratorios Ern S.A.

Investigational products

Investigational Product Name
FOSFOMYCIN
Active Substance
FOSFOMYCIN CALCIUM
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2 (marketingAuthNumber: "-")
Maximum Dose
maxDailyDoseAmount 1500 mg; maxTotalDoseAmount 500 mg

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