Clinical trial • Not applicable • Gastroenterology
MOXIFLOXACIN for Acute appendicitis (uncomplicated) | Acute appendicitis (complicated)
Not applicable trial of MOXIFLOXACIN for Acute appendicitis (uncomplicated) | Acute appendicitis (complicated).
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Acute appendicitis (uncomplicated) | Acute appendicitis (complicated)
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 31-10-2024
- First CTIS Authorization Date
- 26-11-2024
Trial design
Comparators listed: METRONIDAZOLE (tablet; max daily dose 1500 mg), LEVOFLOXACIN (tablet; max daily dose 500 mg), ERTAPENEM (solution for infusion; max daily dose 1 g). Specific schedule/dosing regimen not specified in the record.-controlled Not applicable trial across 1 site in Finland.
- Comparator
- Comparators listed: METRONIDAZOLE (tablet; max daily dose 1500 mg), LEVOFLOXACIN (tablet; max daily dose 500 mg), ERTAPENEM (solution for infusion; max daily dose 1 g). Specific schedule/dosing regimen not specified in the record.
- Target Sample Size
- 118
Eligibility
Recruits 118 No vulnerable populations selected. Participants must provide signed informed consent; inability to co-operate and give informed consent is an exclusion criterion. Subject information and consent form documents are provided (Finnish and Swedish versions exist)..
- Pregnancy Exclusion
- 2) Pregnancy or lactating
- Vulnerable Population
- No vulnerable populations selected. Participants must provide signed informed consent; inability to co-operate and give informed consent is an exclusion criterion. Subject information and consent form documents are provided (Finnish and Swedish versions exist).
Inclusion criteria
- {"criterion_text":"- 1) Signed informed consent"}
- {"criterion_text":"- 2) Age 18 – 60 years"}
- {"criterion_text":"- 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis or complicated acute appendicitis (appendicolith, perforation, abscess, suspicion of a tumor)."}
Exclusion criteria
- {"criterion_text":"- MAPPAC exclusion criteria follow APPAC II and III criteria:"}
- {"criterion_text":"- 1) Age <18 or > 60 years"}
- {"criterion_text":"- 2) Pregnancy or lactating"}
- {"criterion_text":"- 3) Allergy to contrast media or iodine"}
- {"criterion_text":"- 4) Allergy or contraindication to antibiotic therapy"}
- {"criterion_text":"- 5) Renal insufficiency"}
- {"criterion_text":"- 6) Metformine medication"}
- {"criterion_text":"- 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications)"}
- {"criterion_text":"- 8) Inability to co-operate and give informed consent."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The endpoint of the study is the microbial outcome, which is defined by evaluating the changes in the gut microbiota species variation. Determining the possible correlation of gut microbiota and complicated appendicitis will be performed by comparing the species variation.","definition_or_measurement_approach":"The microbial outcome is defined by evaluating the changes in the gut microbiota species variation; correlation with complicated appendicitis will be assessed by comparing species variation."}
Recruitment
- Planned Sample Size
- 118
- Recruitment Window Months
- 120
- Consent Approach
- Signed informed consent is required from each participant. Exclusion if unable to co-operate and give informed consent. Subject information and informed consent form documents are available (documents include Finnish and Swedish versions). No assent procedures for minors (trial only enrolls adults aged 18–60).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 118
Finland
- Earliest CTIS Part Ii Submission Date
- 15-11-2024
- Latest Decision Or Authorization Date
- 26-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 118
Sites
- Site Name
- Turku University Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Paulina Salminen
- Principal Investigator Email
- paulina.salminen@tyks.fi
- Contact Person Name
- Paulina Salminen
- Contact Person Email
- paulina.salminen@tyks.fi
- Number Of Participants
- 118
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
- 2
- Maximum Dose
- 400 mg (max daily dose)
- Investigational Product Name
- METRONIDAZOLE
- Active Substance
- METRONIDAZOLE
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Maximum Dose
- 1500 mg (max daily dose)
- Investigational Product Name
- LEVOFLOXACIN
- Active Substance
- LEVOFLOXACIN
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- 2
- Maximum Dose
- 500 mg (max daily dose)
- Investigational Product Name
- ERTAPENEM
- Active Substance
- ERTAPENEM
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- 2
- Maximum Dose
- 1 g (max daily dose)
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