Clinical trial • Gastroenterology
Levofloxacin for Acute uncomplicated appendicitis
Clinical trial of Levofloxacin for Acute uncomplicated appendicitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Acute uncomplicated appendicitis
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 21-01-2025
- First CTIS Authorization Date
- 29-01-2025
Trial design
Randomised, placebo manufactured by the hospital pharmacy (packaged identically for blinding) versus antibiotic therapy. antibiotic products listed in trial: levofloxacin (oral, max daily dose 500 mg), metronidazole (oral, max daily dose 1500 mg), ertapenem (iv infusion, max daily dose 1 g).-controlled trial across 5 sites in Finland.
- Randomised
- Yes
- Comparator
- Placebo manufactured by the hospital pharmacy (packaged identically for blinding) versus antibiotic therapy. Antibiotic products listed in trial: LEVOFLOXACIN (oral, max daily dose 500 mg), METRONIDAZOLE (oral, max daily dose 1500 mg), ERTAPENEM (IV infusion, max daily dose 1 g).
- Target Sample Size
- 72
- Trial Duration For Participant
- 3650
Eligibility
Recruits 72 Vulnerable population not selected. Participants must provide signed informed consent; inability to co-operate and give informed consent is listed as an exclusion criterion. Consent/assent handled via subject information and informed consent forms (see provided documents)..
- Pregnancy Exclusion
- 2) Pregnancy or lactating
- Vulnerable Population
- Vulnerable population not selected. Participants must provide signed informed consent; inability to co-operate and give informed consent is listed as an exclusion criterion. Consent/assent handled via subject information and informed consent forms (see provided documents).
Inclusion criteria
- {"criterion_text":"- 1) Signed informed consent\n- 2) Age 18 – 60 years\n- 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis."}
Exclusion criteria
- {"criterion_text":"- 1) Age <18 or > 60 years\n- 2) Pregnancy or lactating\n- 3) Allergy to contrast media or iodine\n- 4) Renal insufficiency\n- 5) Allergy or contraindication to antibiotic therapy 6) Metformine medication\n- 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications)\n- 8) Complicated acute appendicitis in a CT scan (appendicolith, perforation, abscess, suspicion of a tumor)\n- 9) Inability to co-operate and give informed consent."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The primary endpoint is the success of the randomized treatment (treatment efficacy). The treatment success is defined as the resolution of acute appendicitis with study treatment resulting in discharge from the hospital without the need for surgical intervention and treatment efficacy evaluated at ten days after initiation of the randomized treatment.","definition_or_measurement_approach":"Treatment success defined as resolution of acute appendicitis resulting in discharge from hospital without need for surgical intervention; efficacy evaluated at 10 days after initiation of randomized treatment."}
Secondary endpoints
- {"endpoint_text":"- Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after study treatment defined as clear clinical suspicion of acute appendicitis evaluated at follow-up of one, three, five and ten years, duration of hospital stay, VAS scores, quality of life (QOL, 15D), sick leave and treatment costs.","definition_or_measurement_approach":"Post-intervention complications classified by Clavien-Dindo; recurrence assessed by clinical suspicion at follow-ups at 1, 3, 5 and 10 years; additional measures include duration of hospital stay, VAS pain scores, 15D quality-of-life instrument, sick leave, and treatment cost assessments."}
Recruitment
- Planned Sample Size
- 72
- Recruitment Window Months
- 156
- Consent Approach
- Signed informed consent is required from participants. Inability to co-operate and give informed consent is an exclusion. Subject information and informed consent forms are provided (documents include Finnish and a Swedish version). Both public and scientific contact provided by the sponsor for consent queries.
Geography
- Total Number Of Sites
- 5
- Total Number Of Participants
- 72
Finland
- Earliest CTIS Part Ii Submission Date
- 21-01-2025
- Latest Decision Or Authorization Date
- 29-01-2025
- Processing Time Days
- 8
- Number Of Sites
- 5
- Number Of Participants
- 72
Sites
- Site Name
- Kuopio University Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Tuomo Rantanen
- Principal Investigator Email
- tuomo.rantanen@kuh.fi
- Contact Person Name
- Tuomo Rantanen
- Contact Person Email
- tuomo.rantanen@kuh.fi
- Site Name
- Oulu University Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Tero Rautio
- Principal Investigator Email
- tero.rautio@oulu.fi
- Contact Person Name
- Tero Rautio
- Contact Person Email
- tero.rautio@oulu.fi
- Site Name
- Tampere University Hospital
- Department Name
- Surgery
- Principal Investigator Name
- Pia Nordström
- Principal Investigator Email
- pia.nordstrom@pirha.fi
- Contact Person Name
- Pia Nordström
- Contact Person Email
- pia.nordstrom@pirha.fi
- 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
- Site Name
- HUS-Yhtymae
- Department Name
- Surgery
- Principal Investigator Name
- Ari Leppäniemi
- Principal Investigator Email
- ari.leppaniemi@hus.fi
- Contact Person Name
- Ari Leppäniemi
- Contact Person Email
- ari.leppaniemi@hus.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
- LEVOFLOXACIN
- Active Substance
- Levofloxacin
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- No marketing authorisation (marketingAuthNumber '-')
- Frequency
- Max daily dose 500 mg
- Maximum Dose
- Max daily dose 500 mg; max total dose 2000 mg
- Investigational Product Name
- ERTAPENEM
- Active Substance
- Ertapenem
- Modality
- Small molecule
- Routes Of Administration
- IV INFUSION
- Route
- IV INFUSION
- Authorisation Status
- No marketing authorisation (marketingAuthNumber '-')
- Frequency
- Max daily dose 1 g
- Maximum Dose
- Max daily dose 1 g; max total dose 3 g
- Investigational Product Name
- METRONIDAZOLE
- Active Substance
- Metronidazole
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- No marketing authorisation (marketingAuthNumber '-')
- Frequency
- Max daily dose 1500 mg
- Maximum Dose
- Max daily dose 1500 mg; max total dose 6000 mg
- Investigational Product Name
- The placebo used in the study was manufactured by the hospital pharmacy. Both the investigational drugs and the placebo were packaged in identical containers by the hospital pharmacy to ensure blinding.
- Modality
- Other
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