Clinical trial • Gastroenterology
MOXIFLOXACIN for Uncomplicated acute appendicitis
Clinical trial of MOXIFLOXACIN for Uncomplicated acute appendicitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Uncomplicated acute appendicitis
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-10-2024
- First CTIS Authorization Date
- 20-11-2024
Trial design
Randomised, open-label, comparators: levofloxacin (oral; max daily dose 500 mg; max total dose 2500 mg), metronidazole (oral; max daily dose 1500 mg; max total dose 7500 mg), ertapenem (solution for infusion; iv infusion; max daily dose 1 g; max total dose 2 g). test product: moxifloxacin (oral; max daily dose 400 mg; max total dose 2800 mg; max treatment period 7 days).-controlled trial in Finland.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparators: LEVOFLOXACIN (oral; max daily dose 500 mg; max total dose 2500 mg), METRONIDAZOLE (oral; max daily dose 1500 mg; max total dose 7500 mg), ERTAPENEM (solution for infusion; IV infusion; max daily dose 1 g; max total dose 2 g). Test product: MOXIFLOXACIN (oral; max daily dose 400 mg; max total dose 2800 mg; max treatment period 7 days).
- Target Sample Size
- 599
- Trial Duration For Participant
- 365
Eligibility
Recruits 599 Vulnerable population not selected. Participants must be able to co-operate and give informed consent; 'Inability to co-operate and give informed consent' is an exclusion criterion. Subject information and informed consent forms are provided (documents listed in the submission: 'APPAC II potilassuostumus', 'Potilastiedote APPAC II 310516 final', 'Potilastiedote APPAC II poissulkeutuneet'). No assent process for minors is described (trial enrols adults 18–60 years)..
- Pregnancy Exclusion
- 2) Pregnancy or lactation,
- Vulnerable Population
- Vulnerable population not selected. Participants must be able to co-operate and give informed consent; 'Inability to co-operate and give informed consent' is an exclusion criterion. Subject information and informed consent forms are provided (documents listed in the submission: 'APPAC II potilassuostumus', 'Potilastiedote APPAC II 310516 final', 'Potilastiedote APPAC II poissulkeutuneet'). No assent process for minors is described (trial enrols adults 18–60 years).
Inclusion criteria
- {"criterion_text":"- 1) Age 18–60 years"}
- {"criterion_text":"- 2) Diagnosis of uncomplicated acute appendicitis confirmed by CT scan defined by the following criteria: appendiceal diameter exceeding 6 mm with thickened and enhancing wall and periappendiceal edema and /or minor fluid collection, and the absence of the criteria of complicated appendicitis. The CT findings will be evaluated using a standardised CT scan report sheet"}
Exclusion criteria
- {"criterion_text":"- 1) Age under 18 or over 60 years"}
- {"criterion_text":"- 2) Pregnancy or lactation,"}
- {"criterion_text":"- 3) Allergy to contrast media or iodine,"}
- {"criterion_text":"- 4) Allergy or contraindication to antibiotic therapy,"}
- {"criterion_text":"- 5) Renal insufficiency or serum creatinine value exceeding the upper reference limit,"}
- {"criterion_text":"- 6) Type 2 diabetes mellitus and metformine medication,"}
- {"criterion_text":"- 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medication),"}
- {"criterion_text":"- 8) Inability to co-operate and give informed consent, and"}
- {"criterion_text":"- 9) Complicated acute appendicitis in the CT scan."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint of the APPAC II trial is defined as the success of the randomised treatment at one-year follow-up (treatment efficacy). Treatment success in both groups is defined as the resolution of acute appendicitis with antibiotic treatment resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a follow-up of one year.","definition_or_measurement_approach":"Treatment success defined as resolution of acute appendicitis with antibiotic treatment resulting in discharge from hospital without need for surgical intervention and no recurrent appendicitis during one-year follow-up."}
Secondary endpoints
- {"endpoint_text":"- post-intervention complications (possible postoperative complications classified using the Clavien-Dindo classification)","definition_or_measurement_approach":"Classified using the Clavien-Dindo classification."}
- {"endpoint_text":"- late recurrence (after one year) of acute appendicitis after antibiotic treatment","definition_or_measurement_approach":"Occurrence of recurrent appendicitis after one year following antibiotic treatment."}
- {"endpoint_text":"- duration of hospital stay","definition_or_measurement_approach":"Measured as length of inpatient stay (days)."}
- {"endpoint_text":"- VAS scores","definition_or_measurement_approach":"Pain assessed using Visual Analogue Scale (VAS)."}
- {"endpoint_text":"- quality of life (QOL, using for example 5D or 15D validated QOL questionnaire)","definition_or_measurement_approach":"Quality of life measured using validated QOL questionnaires such as 5D or 15D."}
- {"endpoint_text":"- length of sick leave","definition_or_measurement_approach":"Measured as duration of sick leave (days)."}
- {"endpoint_text":"- treatment costs","definition_or_measurement_approach":"Health economic assessment of treatment-related costs."}
Recruitment
- Planned Sample Size
- 599
- Recruitment Window Months
- 244
- Consent Approach
- Participants must be able to co-operate and provide informed consent; inability to co-operate and give informed consent is an exclusion criterion. Subject information and informed consent forms are included in the submission (documents: 'APPAC II potilassuostumus', 'Potilastiedote APPAC II 310516 final', 'Potilastiedote APPAC II poissulkeutuneet'). No age-specific assent process is described (trial enrols adults 18–60 years).
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 599
Finland
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 20-11-2024
- Processing Time Days
- 5
- Number Of Sites
- 9
- Number Of Participants
- 599
Sites
- Site Name
- Mikkeli Central Hospital
- Department Name
- Surgery
- Contact Person Name
- Imre Ilves
- Contact Person Email
- imre.ilves@utu.fi
- Site Name
- Seinäjoki Central Hospital
- Department Name
- Surgery
- Contact Person Name
- Tarja Pinta
- Contact Person Email
- tarja.pinta@utu.fi
- Site Name
- Tampere University Hospital
- Department Name
- Surgery
- Contact Person Name
- Pia Nordström
- Contact Person Email
- pia.nordstrom@pirha.fi
- Site Name
- Oulu University Hospital
- Department Name
- Surgery
- Contact Person Name
- Tero Rautio
- Contact Person Email
- tero.rautio@oulu.fi
- Site Name
- Kuopio University Hospital
- Department Name
- Surgery
- Contact Person Name
- Tuomo Rantanen
- Contact Person Email
- tuomo.rantanen@kuh.fi
- Site Name
- Lapland Central Hospital
- Department Name
- Surgery
- Contact Person Name
- Jukka Rintala
- Contact Person Email
- Jukka.rintala@pohde.fi
- Site Name
- Turku University Hospital
- Department Name
- Surgery
- Contact Person Name
- Paulina Salminen
- Contact Person Email
- paulina.salminen@tyks.fi
- Site Name
- Central Finland Hospital District Central Finland Hospital Nova
- Department Name
- Surgery
- Contact Person Name
- Anne Mattila
- Contact Person Email
- anne.mattila@ksshp.fi
- Site Name
- Pori Central Hospital
- Department Name
- Surgery
- Contact Person Name
- Eeva-Liisa Sävelä
- Contact Person Email
- eeva-liisa.savela@utu.fi
Sponsor
Primary sponsor
- Full Name
- Turku University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Investigational products
- Investigational Product Name
- MOXIFLOXACIN
- Active Substance
- MOXIFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2; marketingAuthNumber -
- Maximum Dose
- 400 mg milligram(s) per day
- Investigational Product Name
- LEVOFLOXACIN
- Active Substance
- LEVOFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2; marketingAuthNumber -
- Maximum Dose
- 500 mg milligram(s) per day
- Investigational Product Name
- METRONIDAZOLE
- Active Substance
- METRONIDAZOLE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus 2; marketingAuthNumber -
- Maximum Dose
- 1500 mg milligram(s) per day
- Investigational Product Name
- ERTAPENEM
- Active Substance
- ERTAPENEM
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- prodAuthStatus 2; marketingAuthNumber -
- Maximum Dose
- 1 g gram(s) per day
- Combination Treatment
- Yes
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