Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
72
Countries
1
Sites
5
Uncomplicated acute appendicitis
The aim of the study is to compare antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis to evaluate the role of antibiotic therapy in the resolution of acute uncomplicated appendicitis.
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520761-44-00
- EudraCT number
- 2015-003634-26
- ClinicalTrials.gov
- NCT03234296
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
The aim of the study is to compare antibiotic therapy with placebo in the treatment of uncomplicated acute appendicitis to evaluate the role of antibiotic therapy in the resolution of acute
uncomplicated appendicitis.
Conditions and MedDRA coding
Uncomplicated acute appendicitis
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518984-36-00 | Optimizing the antibiotic treatment of uncomplicated acute appendicitis: a prospective randomized multicenter study | Turku University Hospital |
| 2024-519339-40-00 | Antibiotic therapy vs. placebo in the treatment of acute uncomplicated appendicitis: a prospective randomized double-blind placebo-controlled trial - APPAC III | Turku University Hospital |
| 2023-506213-21-00 | Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis: a Randomized Double-blind Placebo-controlled Noninferiority Trial APPAC IV | Turku University Hospital |
| 2024-519392-26-00 | Acute appendicitis and microbiota – etiology and effects of the antimicrobial treatment - MAPPAC | Turku University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Signed informed consent, 2) Age 18 – 60 years, 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis.
Exclusion criteria 1
- 1) Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Renal insufficiency, 5) Allergy or contraindication to antibiotic therapy 6) Metformine medication, 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications), 8) Complicated acute appendicitis in a CT scan (appendicolith, perforation, abscess, suspicion of a tumor), 9) Inability to co-operate and give informed consent.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Secondary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB08471MIG · Substance
- Active substance
- Levofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25388 · Substance
- Active substance
- Ertapenem
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- IV INFUSION
- Max daily dose
- 1 g gram(s)
- Max total dose
- 3 g gram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08922MIG · Substance
- Active substance
- Metronidazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Paulina Salminen
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Paulina Salminen
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 72 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Turku University Hospital
Surgery, Kiinamyllynkatu 4-8, 20520, Turku
Kuopio University Hospital
Surgery, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Oulu University Hospital
Surgery, Kajaanintie 50, 90220, Oulu
HUS-Yhtymae
Surgery, Kasarmikatu 11-13, 00130, Helsinki
Tampere University Hospital
Surgery, Kalevantie 4, 33100, Tampere
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | APPAC III Study plan final | 1 |
| Recruitment arrangements (for publication) | Suostumusprosessin kuvaus APPAC III | 1 |
| Subject information and informed consent form (for publication) | APPAC III Potilastiedote ja -suostumus Tukija 6 9 2016 final | 1 |
| Subject information and informed consent form (for publication) | APPAC III Potilastiedote ja -suostumus Tukija 6 9 2016 pa svenska | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-21 | Finland | Acceptable 2025-01-29
|
2025-01-29 |