Overview
Sponsor-declared trial summary
Uncomplicated acute appendicitis
The aim of the study is to evaluate the etiology of acute appendicitis and evaluate the effects of antimicrobial treatment on gut microbiota as well as to evaluate the effects of the duration of hospital stay on the AMR reservoir of the gut microbiota
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)
- 2024-11-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519392-26-00
- EudraCT number
- 2016-003655-29
- ClinicalTrials.gov
- NCT03257423
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacoeconomic, Therapy, Safety
The aim of the study is to evaluate the etiology of acute appendicitis and evaluate the effects of antimicrobial treatment on gut microbiota as well as to evaluate the effects of the duration of hospital stay on the AMR reservoir of the gut microbiota
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 |
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 or complicated acute appendicitis (appendicolith, perforation, abscess, suspicion of a tumor).
Exclusion criteria 1
- MAPPAC exclusion criteria follow APPAC II and III criteria: 1) Age <18 or > 60 years, 2) Pregnancy or lactating, 3) Allergy to contrast media or iodine, 4) Allergy or contraindication to antibiotic therapy 5) Renal insufficiency, 6) Metformine medication, 7) Severe systemic illness (for example malignancy, medical condition requiring immunosuppressant medications), 8) Inability to co-operate and give informed consent.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB09086MIG · Substance
- Active substance
- Moxifloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2800 mg milligram(s)
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
SUB08922MIG · Substance
- Active substance
- Metronidazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 7500 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08471MIG · Substance
- Active substance
- Levofloxacin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 2500 mg milligram(s)
- Max treatment duration
- 5 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
- 2 g gram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 118 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | MAPPAC study plan final 21 3 17 | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements MAPPAC | 1 |
| Recruitment arrangements (for publication) | Suostumusprosessin kuvaus APPAC II | 1 |
| Recruitment arrangements (for publication) | Suostumusprosessin kuvaus APPAC III | 1 |
| Subject information and informed consent form (for publication) | MAPPAC potilastiedote ja -suostumus final 10 1 2017 | 1 |
| Subject information and informed consent form (for publication) | MAPPAC potilastiedote ja -suostumus final pa svenska 1 3 17 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-31 | Finland | Acceptable 2024-11-26
|
2024-11-26 |