Clinical trial • Not applicable • Gastroenterology
METRONIDAZOLE for Perianal abscess
Not applicable trial of METRONIDAZOLE for Perianal abscess.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Perianal abscess
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 09-10-2024
- First CTIS Authorization Date
- 11-11-2024
Trial design
Randomised, placebo tablets, tiofarma b.v.; dose/schedule not specified in the provided record-controlled Not applicable trial across 11 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Placebo tablets, Tiofarma B.V.; dose/schedule not specified in the provided record
- Target Sample Size
- 298
- Trial Duration For Participant
- 365
Eligibility
Recruits 298 Vulnerable populations not selected. Only adults >18 years are eligible. Written informed consent is required ("Obtained written informed consent"). No assent or child/under‑18 consent procedures are described. Participants must have sufficient understanding of the Dutch written language..
- Pregnancy Exclusion
- Pregnancy or lactation
- Vulnerable Population
- Vulnerable populations not selected. Only adults >18 years are eligible. Written informed consent is required ("Obtained written informed consent"). No assent or child/under‑18 consent procedures are described. Participants must have sufficient understanding of the Dutch written language.
Inclusion criteria
- {"criterion_text":"- Adults >18 years old\n- Eligible for email questionnaires\n- Sufficient understanding of the Dutch written language (reading and writing)\n- Obtained written informed consent"}
Exclusion criteria
- {"criterion_text":"- A coexistent anorectal/anal fistula\n- Kidney failure (eGFR <30 ml/min)\n- Pregnancy or lactation\n- Postoperative antibiotic prophylaxis indicated for another reason\n- Immunosuppressive medication at the time of surgery\n- Allergy to ciprofloxacin or metronidazole\n- Not able or trouble with swallowing pills\n- 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).\n- Recurrent anorectal abscess\n- Any additional surgical procedure performed during the same session\n- Previous (peri)anal surgery\n- Inflmmatory bowel disease\n- History of radiation of the pelvic area\n- (previous) anorectal malignancy\n- Immunodeficiency\n- Valvular heart disease"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Development of a perianal fistula within one year.","definition_or_measurement_approach":"Assessment of the occurrence/development of a perianal fistula within one year after surgical drainage."}
Secondary endpoints
- {"endpoint_text":"- Quality of life at 12 months","definition_or_measurement_approach":"Quality of life measured at 12 months (timepoint specified)."}
- {"endpoint_text":"- Costs and cost-effectiveness","definition_or_measurement_approach":"Health economic analysis of costs and cost-effectiveness (method not specified)."}
- {"endpoint_text":"- Need of repeated drainage","definition_or_measurement_approach":"Occurrence/requirement of repeated drainage procedures (measurement method not specified)."}
- {"endpoint_text":"- Recurrent abscess","definition_or_measurement_approach":"Occurrence of recurrent perianal abscess (measurement method not specified)."}
- {"endpoint_text":"- Complications","definition_or_measurement_approach":"Complications/adverse events related to treatment (measurement method not specified)."}
- {"endpoint_text":"- Patient reported outcomes measures","definition_or_measurement_approach":"Patient-reported outcome measures (PROMs); instruments not specified."}
- {"endpoint_text":"- Length of hospital stay","definition_or_measurement_approach":"Duration of hospital stay measured in days."}
- {"endpoint_text":"- Readmissions","definition_or_measurement_approach":"Hospital readmissions (counts/occurrence; measurement method not specified)."}
- {"endpoint_text":"- Time till return to work","definition_or_measurement_approach":"Time to return to work measured (presumably in days); exact measurement approach not specified."}
Recruitment
- Planned Sample Size
- 298
- Recruitment Window Months
- 54
- Consent Approach
- Written informed consent is required and must be obtained from participants (adults >18). A subject information sheet and informed consent form (L1_SIS and ICF) are listed. Participants must have sufficient understanding of the Dutch written language. No assent or minor consent procedures described; consent materials language(s) implied to be Dutch.
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 298
Netherlands
- Latest Decision Or Authorization Date
- 11-11-2024
- Number Of Sites
- 11
- Number Of Participants
- 298
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Willem Bemelman
- Principal Investigator Email
- w.a.bemelman@amsterdamumc.nl
- Contact Person Name
- Willem Bemelman
- Contact Person Email
- w.a.bemelman@amsterdamumc.nl
- Site Name
- Amphia Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Ninos Ayez
- Principal Investigator Email
- nayez@amphia.nl
- Contact Person Name
- Ninos Ayez
- Contact Person Email
- nayez@amphia.nl
- Site Name
- IJsselland Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- Oddeke van Ruler
- Principal Investigator Email
- dkehrer@ysl.nl
- Contact Person Name
- Oddeke van Ruler
- Contact Person Email
- dkehrer@ysl.nl
- Site Name
- Proctos kliniek
- Department Name
- Surgery
- Principal Investigator Name
- Justin van Oostendorp
- Principal Investigator Email
- j.vanoostendorp@proctoskliniek.nl
- Contact Person Name
- Justin van Oostendorp
- Contact Person Email
- j.vanoostendorp@proctoskliniek.nl
- Site Name
- Rode Kruis Ziekenhuis B.V.
- Department Name
- Surgery
- Principal Investigator Name
- Frederik Jonker
- Principal Investigator Email
- wetenschapsbureau@rkz.nl
- Contact Person Name
- Frederik Jonker
- Contact Person Email
- wetenschapsbureau@rkz.nl
- Site Name
- Diakonessenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Anandi Schiphorst
- Principal Investigator Email
- wetenschapsbureau@diakhuis.nl
- Contact Person Name
- Anandi Schiphorst
- Contact Person Email
- wetenschapsbureau@diakhuis.nl
- Site Name
- Stichting OLVG
- Department Name
- Surgery
- Principal Investigator Name
- Ruben van Veen
- Principal Investigator Email
- rvanveen@olvg.nl
- Contact Person Name
- Ruben van Veen
- Contact Person Email
- rvanveen@olvg.nl
- Site Name
- Stichting OLVG
- Department Name
- Surgery
- Principal Investigator Name
- Ruben van Veen
- Principal Investigator Email
- rvanveen@olvg.nl
- Contact Person Name
- Ruben van Veen
- Contact Person Email
- rvanveen@olvg.nl
- Site Name
- Stichting Elisabeth-Tweesteden Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- David Zimmerman
- Principal Investigator Email
- wetenschapsbureau@etz.nl
- Contact Person Name
- David Zimmerman
- Contact Person Email
- wetenschapsbureau@etz.nl
- Site Name
- Dijklander Ziekenhuis
- Department Name
- Surgery
- Principal Investigator Name
- Marc Govaert
- Principal Investigator Email
- DOC@dijklander.nl
- Contact Person Name
- Marc Govaert
- Contact Person Email
- DOC@dijklander.nl
- Site Name
- Flevoziekenhuis Stichting
- Department Name
- Surgery
- Principal Investigator Name
- Ruben Schouten
- Principal Investigator Email
- wetenschapsbureau@flevoziekenhuis.nl
- Contact Person Name
- Ruben Schouten
- Contact Person Email
- wetenschapsbureau@flevoziekenhuis.nl
Sponsor
Primary sponsor
- Full Name
- Amsterdam UMC Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Co-sponsors
- Proctos kliniek
Investigational products
- Investigational Product Name
- Metronidazol Aurobindo 500 mg, filmomhulde tabletten
- Active Substance
- METRONIDAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (RVG 08652) Netherlands
- Starting Dose
- 500 mg
- Dose Levels
- 500 mg (film-coated tablet strength)
- Maximum Dose
- 2400 mg/day (maxDailyDoseAmount)
- Investigational Product Name
- Ciprofloxacine Teva 500 mg filmomhulde tabletten
- Active Substance
- CIPROFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation (BE291453) Belgium
- Starting Dose
- 500 mg
- Dose Levels
- 500 mg (film-coated tablet strength)
- Maximum Dose
- 1500 mg/day (maxDailyDoseAmount)
- Investigational Product Name
- Placebo tablets, Tiofarma B.V.,
- Modality
- Other
- Combination Treatment
- Yes
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