Exploratory Pragmatic trial of fosfomycin-trometamol treatment of male urinary tract infections in primary care.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHU De Rouen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Male Urogenital Diseases [C12]

Decision date (initial)

2024-10-18

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Appel d’Offre AAP ReSP-Ir 2021 via le financement de la DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Evaluation of the efficacy of sequential treatment with Fosfomycin Trometamol (FT) for 14 days

Secondary objectives 5

1. Nosological description (clinical and biological) of non-febrile MUIs managed in primary care
2. Clinical cure rate 10 to 12 weeks after inclusion (i.e. 8 to 10 weeks after end of FT treatment)
3. Microbiological cure rate (assessed by urine cytobacteriological examination), 14 to 21 days and 10 to 12 weeks after inclusion
4. Creation of a strain of uropathogens responsible for UTIs
5. Creation of a strain of uropathogens responsible for UTIs

Conditions and MedDRA coding

Male Urinary Tract Infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Men aged 18 and over
2. Consultant patient in a general practice
3. Suspected of MUI by their investigating physician AND presenting at least one recent acute sign (< 3 months) from among the following: - functional urinary signs: urinary burning, urgency, pollakiuria, dysuria, haematuria - pelvic pain independent of micturition: suprapubic, perineal, urethral
4. Patient has read and understood the information letter and signed the consent form
5. Membership of a social security scheme or beneficiary of such a scheme
6. Patient unable to understand the conditions required for participation in the protocol or unable to give informed consent

Exclusion criteria 20

1. Presence of one or more infection severity criteria: - Severe sepsis or septic shock defined by a qSOFA score ≥ 2 - or/and systolic BP below 100 mmHg: non-inclusion criterion - or/and temperature < 36°C or > 38°C - or/and diagnosis of pyelonephritis (pain on lumbar percussion) - or/and presence of abdominal guarding/contraction - or/and presence of a suprapubic vesical globe: (suspicion of acute urine retention) - or/and known immunosuppression: any immunosuppressive treatment (including corticosteroid therapy > 10 mg/d for more than 5 days), neutropenia (PNN < 500/mL) severe undernutrition (Albumin < 30 and/or BMI < 16),
2. No diagnosis of male urinary tract infection in the last 3 months
3. No ongoing chronic prostatitis
4. Known urinary tract anomaly: urinary tract lithiasis, vesicoureteral reflux, prostate or urinary tract cancer, medically or surgically treated prostate adenoma, urinary tract malformation (including single kidney and urethral stricture)
5. Acute urine retention and indication for surgical or interventional drainage
6. Hyperalgesic form
7. Care-associated urinary tract infection on urinary catheter or suprapubic catheter
8. Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterization less than 3 months old
9. Urethral discharge or context suggestive of sexually transmitted infection
10. Severe illness or high probability of death within 3 months
11. Hypersensitivity to fosfomycin trometamol or to any of the excipients (notable excipients: sucrose, dextrose (source of glucose), maltodextrin (source of glucose), orange yellow colouring S (E110)).
12. End-stage renal disease (creatinine clearance <10 mL/min)
13. Patients with glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease).
14. Antibiotics taken within 72 hours of diagnosis of male urinary tract infection
15. Major cognitive disorders
16. Persons deprived of their liberty by an administrative or judicial decision or guardianship persons placed under guardianship with representation relating to the person, persons placed under a mandate for future protection, persons benefiting from family habilitation, persons under guardianship, persons under court protection
17. History of psychological or sensory illness or abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or from giving informed consent.
18. Known non-compliance with medication
19. Simultaneous participation in another clinical intervention study
20. Oral treatment not possible (vomiting).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint was defined as the absence of clinical treatment failure up to 14 days after the end of antibiotic treatment. Failure is defined according to SPILF recommendations by : - a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ; - or/and hospitalization for urinary tract infection ; - or/and acute retention of urine ; - or/and a new consultation for worsening or persistence of symptoms ; - or/and onset of fever > 38°C

Secondary endpoints 5

1. Improvement in functional urinary symptomatology, 2-5 days 28-35 days and 3 months after the start of treatment with FT
2. Negative ECBU 10 to 12 weeks after end of treatment
3. negative ECBU (leukocyturia < 10/mm3 OR leukocyturia > 10/mm3 AND bacteriuria < 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment
4. Regression of urinary signs 10 to 12 weeks after the end of treatment
5. Adverse events reported by the patient and recorded by the investigating physician during antibiotic treatment and in the 14 days following the end of treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU De Rouen

Sponsor organisation

CHU De Rouen

Address

1 Rue De Germont, Bp 96031 Bp 96031

City

Rouen Cedex

Postcode

76031

Country

France

Scientific contact point

Organisation

CHU De Rouen

Contact name

MALLET

Public contact point

Organisation

CHU De Rouen

Contact name

MALLET

Locations

1 EU/EEA country · 32 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications