Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
298
Countries
1
Sites
11
Perianal abscess
The main objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
Key facts
- Sponsor
- Amsterdam UMC Stichting, Proctos kliniek
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMw
External identifiers
- EU CT number
- 2024-517233-40-00
- EudraCT number
- 2020-004449-35
- ClinicalTrials.gov
- NCT05385887
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Therapy
The main objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
Secondary objectives 7
- Quality of life
- Costs and cost-effectiveness
- Recurrent abscesses
- Repeated drainage
- Patient reported outcome measures
- Complications
- Clinical outcomes
Conditions and MedDRA coding
Perianal abscess
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10002645 | Anorectal fistula | 10017947 |
| 20.0 | PT | 10002156 | Anal fistula | 100000004856 |
| 20.0 | LLT | 10048428 | Abscess perianal | 10021881 |
| 20.0 | LLT | 10013623 | Drainage of perianal abscess | 10042613 |
| 20.1 | LLT | 10034447 | Perianal abscess | 10021881 |
| 20.1 | LLT | 10002645 | Anorectal fistula | 10017947 |
| 20.0 | LLT | 10034448 | Perianal abscess drainage | 10042613 |
| 20.0 | PT | 10002156 | Anal fistula | 100000004856 |
| 20.1 | LLT | 10068659 | Perianal fistula | 10017947 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adults >18 years old
- Eligible for email questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Exclusion criteria 16
- A coexistent anorectal/anal fistula
- Recurrent anorectal abscess
- Any additional surgical procedure performed during the same session
- Previous (peri)anal surgery
- Inflmmatory bowel disease
- History of radiation of the pelvic area
- (previous) anorectal malignancy
- Immunodeficiency
- Valvular heart disease
- Kidney failure (eGFR <30 ml/min)
- Pregnancy or lactation
- Postoperative antibiotic prophylaxis indicated for another reason
- Immunosuppressive medication at the time of surgery
- Allergy to ciprofloxacin or metronidazole
- Not able or trouble with swallowing pills
- Concomitant use of:Tizanidine, theophylline, clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine (these are all CYP1A2 substrates, ciprofloxacin is an inhibitor) o Amiodarone, erythromycin, sotalol, azithromycin, citalopram, escitalopram, flecainide, fluconazole, haloperidol >5mg/day, methadone, ondansetron (concerning prolonged QT interval in combination with ciprofloxacin), Lithium (can cause toxic levels with metronidazole), Lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram (antabuse), mebendazole (can cause serious side effects, confusion and psychosis in combination with metronidazole), corticosteroids (in combination with ciprofloxacin higher risk of tendinitis and tendon rupture).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Development of a perianal fistula within one year.
Secondary endpoints 9
- Quality of life at 12 months
- Costs and cost-effectiveness
- Need of repeated drainage
- Recurrent abscess
- Complications
- Patient reported outcomes measures
- Length of hospital stay
- Readmissions
- Time till return to work
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Metronidazol Aurobindo 500 mg, filmomhulde tabletten
PRD1780559 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2400 mg milligram(s)
- Max total dose
- 16800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01XD01 — METRONIDAZOLE
- Marketing authorisation
- RVG 08652
- MA holder
- AUROBINDO PHARMA B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ciprofloxacine Teva 500 mg filmomhulde tabletten
PRD3791646 · Product
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 10500 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- J01MA02 — CIPROFLOXACIN
- Marketing authorisation
- BE291453
- MA holder
- TEVA PHARMA BELGIUM N.V./S.A
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo tablets, Tiofarma B.V.,
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Proctos kliniek
- Contact name
- Principal Investigator
Public contact point
- Organisation
- Proctos kliniek
- Contact name
- Principal Investigator
Proctos kliniek
- Sponsor organisation
- Proctos kliniek
- Address
- Professor Bronkhorstlaan 10, Building 60-62 Building 60-62
- City
- Bilthoven
- Postcode
- 3723 MB
- Country
- Netherlands
Scientific contact point
- Organisation
- Proctos kliniek
- Contact name
- Ingrid Han-Geurts
Public contact point
- Organisation
- Proctos kliniek
- Contact name
- Ingrid Han-Geurts
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 298 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Rode Kruis Ziekenhuis B.V.
Surgery, Vondellaan 13, 1942 LE, Beverwijk
Amphia Hospital
Surgery, Molengracht 21, 4818 CK, Breda
Stichting Elisabeth-Tweesteden Ziekenhuis
Surgery, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Proctos kliniek
Surgery, Professor Bronkhorstlaan 10, Building 60-62, Bilthoven
IJsselland Ziekenhuis
Surgery, Prins Constantijnweg 2, 2906 ZC, Capelle Aan Den Ijssel
Amsterdam UMC Stichting
Surgery, Meibergdreef 9, 1105 AZ, Amsterdam
Stichting OLVG
Surgery, Oosterpark 9, 1091 AC, Amsterdam
Flevoziekenhuis Stichting
Surgery, Hospitaalweg 1, 1315 RA, Almere
Stichting OLVG
Surgery, Jan Tooropstraat 164, 1061 AE, Amsterdam
Dijklander Ziekenhuis
Surgery, Maelsonstraat 3, 1624 NP, Hoorn Nh
Diakonessenhuis Stichting
Surgery, Bosboomstraat 1, 3582 KE, Utrecht
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Procotol_2024-517233-40-00 | 5.0 |
| Recruitment arrangements (for publication) | 2024-517233-40-00_blank document | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_2024-517233-40-00 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ciprofloxacine 500mg Aurobindo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Metronidazol 500mg Aurobindo | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-09 | Netherlands | Acceptable 2024-11-11
|
2024-11-11 |