PLACEBO CONTROLLED STUDY ON PIDOTIMOD IN FEMALE PATIENTS WITH URINARY TRACT INFECTIONS

EXPLORATIVE, RANDOMIZED, PLACEBO CONTROLLED STUDY FOR THE CLINICAL EVALUATION OF PIDOTIMOD IN FEMALE PATIENTS WITH RECURRENT, UNCOMPLICATED URINARY TRACT INFECTIONS.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001606-42-IT

Enrollment

100

Registered

2021-01-20

Start date

2016-07-04

Completion date

Unknown

Last updated

2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent uncomplicated urynary tract infections MedDRA version: 20.0 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection System Organ Class: 100000004862

Interventions

Trade Name: AXIL - 800 MG GRANULATO PER SOLUZIONE ORALE 10 BUSTINE Product Name: AXIL 800 mg granulato per soluzione orale Pharmaceutical Form: Granules for oral solution Pharmaceutical form of the pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who will be included in the study: - female patients in menopausal status (12 months of amenorrhea) and under 75 years; - uncomplicated symptomatic UTI; - documented bacteriuria (> 10^5 per ml of bacterial colonies); - antibiogram available no more than 5 days before enrollment; - with at least 3 episodes of UTI (symptomatic, non-complicated) in the 12 months before the enrollment or at least 2 episodes in the 6 months before; - able to be contacted by telephone during the follow-up phase period; - who have understood and signed the informed consent and release for use of sensitive data. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Patients who will not be included in the study: - over 75 years or not in menopausal status or amenorrhea <12 months; - with diabetic diseases; - with congenital or acquired immunodeficiency; - diagnosed or recurrent cancer disease in the last five years; - treated with immunomodulators (immunosuppressants or immunostimulants), corticosteroids (only under systemic chronic treatment); - with hyper-IgE syndromes; - atopic subjects or with a history of allergic reactions; - with allergies or intolerances to Pidotimod and/or to the excipients; - compliance with negative features.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate in female patients pidotimod effects on relapse number prevention of the Urinary Tract Infection (UTI), symptomatic and uncomplicated. ;Secondary Objective: - to assess the disappearance time of dysuria after the acute phase - to assess the average time of first relapse - to assess the frequency of patients who relapse at least once in the 12 months of the study - to evaluate the metabolic profile of urine before and after the treatment with pidotimod/placebo in 50% of the randomized population;Primary end point(s): Number of relapses of UTI in the following 12 months confirmed by positive urine culture (bacteriuria > 10^5 per ml of bacterial colonies);Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Main Objective: To evaluate in female patients pidotimod effects on relapse number prevention of the Urinary Tract Infection (UTI), symptomatic and uncomplicated. ;Secondary Objective: - to assess the disappearance time of dysuria after the acute phase - to assess the average time of first relapse - to assess the frequency of patients who relapse at least once in the 12 months of the study - to evaluate the metabolic profile of urine before and after the treatment with pidotimod/placebo in 50% of the randomized population;Primary end point(s): Number of relapses of UTI in the following 12 months confirmed by positive urine culture (bacteriuria > 10^5 per ml of bacterial colonies);Timepoint(s) of evaluation of this end point: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): - Disappearance time of dysuria after the acute phase - Average time of relapse - Number of patients with at least 1 relapse in the 12 months following the enrolment - Metabolomic parameters;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Italy

Contacts

Public ContactClinical Department

VALEAS SPA

dir.medica@valeas.it0223690215

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026