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

NCT06210269 | Not Yet Recruiting DMC

• 1 other identifier: APPAC IV
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 9

Brief Summary

APPAC IV, a randomized double-blind multicenter clinical trial comparing once daily oral moxifloxacin with placebo in an outpatient setting aims to evaluate whether antibiotics and hospitalization or both can be omitted in the treatment of uncomplicated appendicitis further significantly increasing cost savings and patient satisfaction. This is a direct research continuum to the previous trial triad: APPAC, APPAC II and APPAC III, which have already established that the majority of patients with uncomplicated acute appendicitis can be safely treated without surgery. The APPAC IV trial is based on a novel concept and approach to further optimize the nonoperative treatment of uncomplicated acute appendicitis with a high potential in resulting in major health care cost savings and potentially also in significant reduction of antibiotic use in an extremely common surgical emergency.

Conditions

Uncomplicated Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• Treatment success.

  The primary outcome is 30-day treatment success defined similarly as in the previous trials, i.e. resolution of acute appendicitis resulting in discharge from the hospital without appendectomy during the 30-day follow-up.

  30 days after treatment initiation

Secondary Outcomes (11)

• Post-intervention complications

  20 years

• Late recurrence of appendicitis

  20 years

• Hospital stay

  20 years

• Admission to hospital

  20 years

• VAS score (visual analogue score)

  20 years

Study Arms (2)

Antibiotic treatment

ACTIVE COMPARATOR

Oral moxifloxacin 400 mg once daily for seven days

Drug: Moxifloxacin 400mg

Placebo

ACTIVE COMPARATOR

Identical oral administration and treatment duration of seven days

Other: Placebo

Interventions

Moxifloxacin 400mg DRUG

Oral antibiotic

Antibiotic treatment

Placebo OTHER

Oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent
• Age 18-60 years
• CT scan confirmed diagnosis of uncomplicated acute appendicitis.

You may not qualify if:

• Complicated acute appendicitis on CT (presence of appendicolith, perforation, abscess, suspicion of tumor, or appendiceal diameter ≥ 15 mm),
• body temperature \> 38°C,
• age younger than 18 or older than 60 years,
• 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),
• severe systemic illness (malignancy, or requiring immunosuppressant medication), and
• all contraindications and other relevant precautions to moxifloxacin (please see list below)
• inability to co-operate and give informed consent.
• Anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide)
• Anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide)
• Antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride)
• Tricyclic antidepressive agents
• Certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine)
• Certain antihistaminics (terfenadine, astemizole, mizolastine)
• Others (cisapride, vincamine IV, bepridil, diphemanil).

Sponsors & Collaborators

• Turku University Hospital: lead
• Tampere University Hospital: collaborator
• Oulu University Hospital: collaborator
• Kuopio University Hospital: collaborator
• Pori Central Hospital: collaborator
• Jyväskylä Central Hospital: collaborator
• Mikkeli Central Hospital: collaborator
• Seinajoki Central Hospital: collaborator
• Päijänne Tavastia Central Hospital: collaborator

Study Sites (9)

Jyväskylä Central Hospital

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Lahti Central Hospital

Lahti, Finland

Location

Mikkeli Central Hospital

Mikkeli, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Pori Central Hospital

Pori, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

• Lund H, Haijanen J, Suominen S, Hurme S, Sippola S, Rantanen T, Rautio T, Mattila A, Pinta T, Nordstrom P, Kossi J, Ilves I, Salminen P. A randomized double-blind noninferiority clinical multicenter trial on oral moxifloxacin versus placebo in the outpatient treatment of uncomplicated acute appendicitis: APPAC IV study protocol. Scand J Surg. 2025 Mar;114(1):3-12. doi: 10.1177/14574969241293018. Epub 2024 Dec 5.

  PMID: 39636024 DERIVED

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Paulina Salminen, Professor

  Turku University Hospital Professor of surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Salminen, Professor

CONTACT

+358407181896; paulina.salminen@tyks.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinding. The colored oral capsules for both study groups will have an identical appearance preventing both specific smell and taste; all drugs will be manufactured with identical labelling. Patients randomly assigned to antibiotics will receive oral moxifloxacin 400 mg once daily for seven days. The patients randomly assigned to placebo will receive an identical once daily oral administration and treatment duration of seven days. If the patient is suspected of not responding to the administered treatment based on clinical findings, the patient will undergo laparoscopic appendectomy based on the decision by the surgeon on call and the reasons for proceeding to appendectomy are recorded. Surgical findings and histopathological examination of the removed appendix will be used to confirm the diagnosis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 18, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2045
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

FI (9)