NCT06210269|Not Yet RecruitingDMC
Oral Antibiotic Outpatient Therapy vs. Placebo in the Treatment of Uncomplicated Acute Appendicitis
APPAC IV
Loading search results
APPAC IV
Sponsor study identifier
interventional
498
1 country
9
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2023
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 18, 2024
Actual (reported)December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
Oral moxifloxacin 400 mg once daily for seven days
Identical oral administration and treatment duration of seven days
Jyväskylä Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Lahti Central Hospital
Lahti, Finland
Mikkeli Central Hospital
Mikkeli, Finland
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.
Paulina Salminen, Professor
Turku University Hospital Professor of surgery
First Submitted
December 22, 2023
First Posted
January 18, 2024
Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM
Contact the study team to confirm eligibility.
Oulu University Hospital
Oulu, Finland
Pori Central Hospital
Pori, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2045
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 18, 2024
Record last verified: 2024-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: