Etiology of appendicitis and effects of antimicrobial treatment

Acute appendicitis and microbiota- etiology and effects of the antimicrobial treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003655-29-FI

Enrollment

200

Registered

2017-01-12

Start date

2017-02-23

Completion date

Unknown

Last updated

2024-12-03

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

Conditions

Acute appendicitis MedDRA version: 19.1 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 or complicated acute appendicitis (appendicolith, perforation, abscess, suspicion of a tumor). 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: MAPPAC exclusion criteria follow APPAC II and III criteria: 1) Age 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: ;Primary end point(s): 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.Th;Timepoint(s) of evaluation of this end point: The timepoints for evaluating the endpoint are: 0 and 1 or 3 days as well as 1 week, 6 months and 1 year for patients also participating in the APPAC III trial and 0 and 1 days for patients also participating in the APPAC II trial.	—

Measure

Time frame

Main Objective: 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;Secondary Objective: ;Primary end point(s): 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.Th;Timepoint(s) of evaluation of this end point: The timepoints for evaluating the endpoint are: 0 and 1 or 3 days as well as 1 week, 6 months and 1 year for patients also participating in the APPAC III trial and 0 and 1 days for patients also participating in the APPAC II trial.

—

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 4, 2026