Antibiotic therapy vs. placebo in the treatment of appendicitis

Antibiotic therapy vs. placebo in the treatment of acute uncomplicated appendicitis: a prospective randomized double-blind placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003634-26-FI

Enrollment

142

Registered

2016-11-24

Start date

2016-12-27

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute uncomplicated appendicitis MedDRA version: 20.0 Level: LLT Classification code 10000677 Term: Acute appendicitis System Organ Class: 100000004862

Interventions

Trade Name: Invanz (Ertapenem) Pharmaceutical Form: Powder for solution for injection/infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use Tra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Signed informed consent, 2) Age 18 – 60 years, 3) CT scan confirmed diagnosis of uncomplicated acute appendicitis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 142 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Age 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 10 days after initiation of the randomized treatment	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: ;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: 10 days after initiation of the randomized treatment

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Secondary

Measure	Time frame
Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: 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.	—

Measure

Time frame

Secondary end point(s): 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.;Timepoint(s) of evaluation of this end point: 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.

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Countries

Finland

Contacts

Public ContactTurku University Hospital

Turku University Hospital

paulina.salminen@tyks.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 12, 2026