Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
526
Countries
1
Sites
9
Patients (male or female) ≥18 years old with Detrusor overactivity (DO) in multiple sclerosis (MS) or spinal cord injured (SCI).
To demonstrate the non-inferiority of “antibiotic sparing strategy” compared to “peri-operative antibiotic strategy” (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injection in the management of asymptomatic bacteriuria (AB) among MS and SCI patients undergoing CISC.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Lille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2025-11-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- DGOS, PHRC-19-0218
External identifiers
- EU CT number
- 2024-515107-19-00
- ClinicalTrials.gov
- NCT05534399
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To demonstrate the non-inferiority of “antibiotic sparing strategy” compared to “peri-operative antibiotic strategy” (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injection in the management of asymptomatic bacteriuria (AB) among MS and SCI patients undergoing CISC.
Secondary objectives 3
- To compare between antibiotic saving strategy and peri-operative antibiotic strategy the others safety and efficacy outcomes
- To study the risk factors associated with post-injection symptomatic Urinary tract infection
- To carry out an ad-hoc health-economic analysis aiming to compare current recommendations (peri-operative antibiotic strategy) with the “antibiotic saving strategy”.
Conditions and MedDRA coding
Patients (male or female) ≥18 years old with Detrusor overactivity (DO) in multiple sclerosis (MS) or spinal cord injured (SCI).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10041552 | Spinal cord injury | 100000004863 |
| 28.0 | LLT | 10039720 | Sclerosis multiple | 10029205 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Female and male over 18 years-old
- Multiple Sclerosis or Spinal Cord Injury (traumatic or non-traumatic)
- Clean Intermittent Self-Catheterization as the exclusive bladder management
- Refractory Detrusor Overactivity leading to urinary incontinence (failure, intolerance or contra-indication to anti-muscarinic therapy)
- Treated with intra-vesical BoNTA injections having proved efficacy
- Asymptomatic Bacteriuria (bacteriuria threshold ≥ 10² CFU/mL) on pre-operative urine analysis (performed 5 days (+/- 2 days) before intra-vesical BoNTA injections)
- With a personal and functional e-mail address, a quasi-permanent Internet connection and a mobile phone.
Exclusion criteria 19
- Contra-Indication to botulinum toxin a, and excipients included in study drugs
- Surgical procedure in the 3 months before and the 6 weeks following inclusion
- Symptomatic UTI at the time of inclusion
- Associated neurologic disease
- • Pregnancy or breast feeding
- Having already participated to the study
- Augmentation cystoplasty
- Bladder compliance disorders (<20 mL/cmH2O)
- Morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI
- Ongoing cyclic antibiotic therapy
- Ongoing corticosteroid therapy
- Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion
- Antibiotic therapy in the month before inclusion
- Absence of use of any recognized contraceptive method (e.g. hormonal, barrier, IUD, sterilization) or of consistent sexual abstinence
- Individuals especially in need of protection
- No informed consent
- Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on.
- Immunocompromised patients
- Patient without easy access to internet within 6 weeks of the injection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of patients with symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection. Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
Secondary endpoints 15
- Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection.
- Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following intra-vesical BoNTA injection.
- Rate of patients with symptomatic UTI within the 6 weeks following intra-vesical BoNTA injection finally needing the administration of an antibiotic therapy.
- Rate of patients with adverse events (other than symptomatic UTI) related to* intra-vesical BoNTA injections occurring within the 6 weeks following the injection.
- Rate of patients with adverse events not related to** intra-vesical BoNTA injection occurring within the 6 weeks following the injection
- Rate of patients with admission to an emergency unit related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection.
- Rate of patients with admission to an emergency unit not related** to intra-vesical BoNTA injection occurring within the 6 weeks following the injection
- Rate of patients with admission in a non-scheduled hospitalization related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection
- Rate of patients with admission in a non-scheduled hospitalization not related to* intra-vesical BoNTA injection occurring within the 6 weeks following the injection.
- Maximal cystometric capacity (MCC) evaluated 6 weeks after BoNTA injection (UDS).
- Rate of patients with DO (unhibited detrusor contraction(s) occurring during feeling phase) evaluated 6 weeks after BoNTA injection (UDS). o If DO: Volume at the first uninhibited detrusor contraction (ml) o If DO: Maximal detrusor pressure (cmH2O)
- Number of CISC per day evaluated 6 weeks after BoNTA injection (3-day bladder diary).
- Number of urgency episodes evaluated 6 weeks after BoNTA injection (3-day bladder diary).
- Number of urinary incontinence episodes per day evaluated 6 weeks after BoNTA injection (3-day bladder diary).
- Functional bladder capacity evaluated 6 weeks after BoNTA injection (3-day bladder diary).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 13
ROCEPHINE 1 g/3,5 ml, poudre et solvant pour solution injectable (IM)
PRD528294 · Product
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 1 g gram(s)
- Max total dose
- 1 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- 34009 326 752 5 8
- MA holder
- ROCHE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SELEXID 200 mg, comprimé pelliculé
PRD6957837 · Product
- Active substance
- Pivmecillinam Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA08 — PIVMECILLINAM
- Marketing authorisation
- 34009 301 049 3 4
- MA holder
- KARO PHARMA AB
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: SELEXID 200mg has not been validated for the treatment of asymptomatic bacteriuria prior to urological procedures. However, it is indicated for the treatment of symptomatic urinary tract infection (cystitis) in women and for asymptomatic bacteriuria during pregnancy.
MONURIL 3 g, granulés pour solution buvable en sachet
PRD485695 · Product
- Active substance
- Fosfomycin Trometamol
- Substance synonyms
- (1R,2S)-1,2-EPOXYPROPYLPHOSPHONIC ACID, COMPOUND WITH 2-AMINO-2-(HYDROXYMETHYL)-1,3-PROPANEDIOL, FOSFOMYCIN TROMETHAMINE
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XX01 — FOSFOMYCIN
- Marketing authorisation
- 34009 332 092 3 0
- MA holder
- ZAMBON FRANCE S.A.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: MONURIL 3g has not been validated for the treatment of asymptomatic bacteriuria. However, it is indicated for the treatment of symptomatic urinary tract infection (cystitis) in women.
PRD8253351 · Product
- Active substance
- Sulfamethoxazole
- Substance synonyms
- SULFISOMEZOLE, SULPHAMETHOXAZOLE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1600 mg milligram(s)
- Max total dose
- 1600 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01EE01 — SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Marketing authorisation
- 34009 3219704 0
- MA holder
- EUMEDICA PHARMACEUTICALS GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: BACTRIM FORTE 800mg/160mg has not been validated for the treatment of asymptomatic bacteriuria. However, it is indicated for the treatment of symptomatic urinary tract infection in men and women.
TAVANIC 500 mg, comprimé pelliculé sécable
PRD2605538 · Product
- Active substance
- Levofloxacin
- Substance synonyms
- HR355
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01MA12 — LEVOFLOXACIN
- Marketing authorisation
- 34009 349 655 6 2
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
AUGMENTIN 500 mg/62,5 mg, comprimé pelliculé (rapport amoxicilline/acide clavulanique : 8/1)
PRD418616 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 3000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 6 356 524 4
- MA holder
- LABORATOIRE GLAXOSMITHKLINE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: AUGMENTIN 500mg/62.5mg has not been validated for the treatment of asymptomatic bacteriuria, including prior to urological procedures. However, it is indicated for the treatment of symptomatic urinary tract infection (cystitis and acute pyelonephritis).
Clamoxyl 1 g, comprimés dispersibles
PRD11713022 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- 2008100030
- MA holder
- GLAXOSMITHKLINE PHARMACEUTICALS EN ABREGE GLAXOSMITHKLINE
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: CLAMOXYL 1g has not been validated for the treatment of asymptomatic bacteriuria prior to urological procedures. However, it is indicated for the treatment of symptomatic urinary tract infection (cystitis and acute pyelonephritis) and for asymptomatic bacteriuria during pregnancy.
OROKEN 200 mg, comprimé pelliculé
PRD10576747 · Product
- Active substance
- Cefixime
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DD08 — -
- Marketing authorisation
- 34009 331 311-3 5
- MA holder
- AMDIPHARM LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: OROKEN 200mg has not been validated for the treatment of asymptomatic bacteriuria. However, it is indicated for the treatment of symptomatic urinary tract infection in women.
ROCEPHINE 1 g/10 ml, poudre et solvant pour solution injectable (IV)
PRD528296 · Product
- Active substance
- Ceftriaxone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- 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
- J01DD04 — -
- Marketing authorisation
- 34009 326 748 8 6
- MA holder
- ROCHE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OFLOCET 200 mg, comprimé pelliculé sécable
PRD12317385 · Product
- Active substance
- Ofloxacin
- Pharmaceutical form
- SCORED FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA01 — OFLOXACIN
- Marketing authorisation
- 34009 329 032 3 8
- MA holder
- TAMRISA ACCESS
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CIFLOX 500 mg, comprimé pelliculé sécable
PRD385406 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- 34009 329 813 5 9
- MA holder
- BAYER HEALTHCARE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DELPRIM 300 mg comprimé sécable
PRD7793661 · Product
- Active substance
- Trimethoprim
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01EA01 — TRIMETHOPRIM
- Marketing authorisation
- 34009 300 577 2 8
- MA holder
- LABORATOIRE CCD
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Description of the modification: DELPRIM 300mg has not been validated for the treatment of asymptomatic bacteriuria. However, it is indicated for the treatment of symptomatic urinary tract infection (cystitis) in women.
AZACTAM 1 g, poudre et solution pour usage parentéral
PRD10590285 · Product
- Active substance
- Aztreonam
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01DF01 — AZTREONAM
- Marketing authorisation
- 34009 369 208 5 9
- MA holder
- AMDIPHARM LIMITED
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Lille
- Sponsor organisation
- Centre Hospitalier Universitaire De Lille
- Address
- 2 Avenue Oscar Lambret, Cs 70001 Cs 70001
- City
- Lille Cedex
- Postcode
- 59037
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- BIARDEAU Xavier
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Lille
- Contact name
- BIARDEAU Xavier
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 526 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Assistance Publique Hopitaux De Paris
Service de Neuro-Urologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Hospitalier Universitaire De Lille
Service d’Urologie et d’Andrologie et de Transplantation rénale, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Rennes
Service d’Urologie, 2 Rue Henri Le Guilloux, 35033, Rennes Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Service d’Urologie, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Nantes
Service d’Urologie, 1 Place Alexis Ricordeau, 44000, Nantes
Hospices Civils De Lyon
Service d’Urologie, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Centre Hospitalier Universitaire De Toulouse
Service d’Urologie et d’Andrologie et de Transplantation rénale, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Assistance Publique Hopitaux De Paris
Service d’Urologie, Num Voie 47 A 83, 47 Boulevard De L Hopital, Paris
Raymond-Poincare Hospital
Service de Neuro-Urologie, 104 Boulevard Raymond Poincare, 92380, Garches
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515107-19-00_redacted | 1.2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_Redacted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AUGMENTIN 500 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AZACTAM 1g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_BACTRIM 800 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CIFLOX 500 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CLAMOXYL 1g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_DELPRIM 300 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_MONURIL 3g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_OFLOCET 200 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_OROKEN 200 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ROCEPHINE IM 1g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ROCEPHINE IV 1g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_SELEXID 200 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_TAVANIC 500 mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-515107-19-00_Redacted | 1.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-18 | France | Acceptable with conditions 2025-11-03
|
2025-11-10 |