Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis

2023-506213-21-00 Protocol APPAC IV Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 9 sites · Protocol APPAC IV

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 498
Countries 1
Sites 9

Uncomplicated acute appendicitis

Can antibiotics be omitted in the treatment of uncomplicated acute 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)
2023-10-23
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
Academy of Finland · Sigrid Juselius Foundation

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Can antibiotics be omitted in the treatment of uncomplicated acute appendicitis?

Secondary objectives 2

  1. Is outpatient treatment of uncomplicated acute appendicitis safe – can hospitalization be avoided?
  2. What are the effects of oral antibiotics on gut microbiota and antibiotic resistance? – Patience safety approach (Microbiology APPAC II)

Conditions and MedDRA coding

Uncomplicated acute appendicitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

  1. Signed informed consent
  2. Age 18–60 years
  3. CT scan confirmed diagnosis of uncomplicated acute appendicitis

Exclusion criteria 6

  1. Complicated acute appendicitis on CT (presence of appendicolith, perforation, abscess, suspicion of tumor, or appendiceal diameter 15 mm or greater)
  2. Body temperature > 38°C
  3. Age younger than 18 or older than 60 years
  4. Contraindications for CT (pregnancy, lactation, allergy to contrast media or iodine, renal insufficiency with serum creatinine exceeding upper reference limit, type 2 diabetes and metformin medication)
  5. Severe systemic illness (malignancy, or requiring immunosuppressant medication)
  6. Inability to co-operate and give informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary outcome is 30-day treatment success defined as resolution of acute appendicitis resulting in discharge from the hospital without appendectomy during the 30-day follow-up

Secondary endpoints 1

  1. Secondary endpoints include post-intervention complications (Clavien-Dindo classification), late recurrence of acute appendicitis after the 30-day follow-up, duration of hospital stay in hours, admission to hospital and reason for admission, readmissions to emergency department or hospitalization, VAS pain scores, quality of life (QOL, EQ-5D-5L), sick leave and overall treatment and societal costs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Moxifloxacin

SUB09086MIG · Substance

Active substance
Moxifloxacin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
1 mg milligram(s)
Max total dose
1 mg milligram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Active investigational medicinal product (imp) contains 400 mg of moxifloxacin (1 x 400 mg tablet). moxifloxacin 400 mg tablets, which are authorized medicinal products, are sourced from legal supply chain of medicinal products at eu and used for preparation of the active imp. tablets are masked by over encapsulation with hard gelatine capsule, 1 x 400 mg in a capsule to maintain blinding. matching placebo imp capsule are prepared containing microcrystalline cellulose.

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

15 Total trials 6 Recruiting
Academic / Non-commercial
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 · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Finland Authorised, recruitment pending 498 9
Rest of world — 0 —

Investigational sites

Finland

9 sites · Authorised, recruitment pending
Pori Central Hospital
Surgery, Sairaalantie 3, 28500, Pori
Tampere University Hospital
Surgery, Teiskontie 35, 33520, Tampere
Lahti Central Hospital
Surgery, Keskussairaalankatu 7, 15850, Lahti
Oulu University Hospital
Surgery, Kajaanintie 50, 90220, Oulu
Seinäjoki Central Hospital
Surgery, Hanneksenrinne 7, 60220, Seinäjoki
Turku University Hospital
Surgery, Hameentie 11, 20520, Turku
Jyväskylä Central Hospital
Surgery, Hoitajantie 3, 40620, Jyväskylä
Mikkeli Central Hospital
Surgery, Porrasssalmenkatu 35, 50100, Mikkeli
Kuopio University Hospital
Surgery, Puijonlaaksontie 2, P. O. Box 1777, Kuopio

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-07-04 Finland Acceptable
2023-10-23
 2023-10-23
2 SUBSTANTIAL MODIFICATION SM-2 2023-11-02 Finland Acceptable 2023-12-01

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