The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis (other than for generalized peritonitis): a prospective, randomized, open-label, non-inferiority Phase III study.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Decision date (initial)

2024-11-20

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

dgos

External identifiers

EU CT number

2024-515834-34-00

EudraCT number

2017-000334-59

ClinicalTrials.gov

NCT03688295

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

evaluate the impact of the absence of post-operative antibiotic therapy on the organ space surgical site infection (SSI) rate in patients presenting with CAA (other than in cases of generalized peritonitis).

Conditions and MedDRA coding

complicated acute appendicitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. CAA confirmed peroperatively by the presence of a perforated appendicitis, extraluminal fecaliths, abscesses and/or localized peritonitis (pus in one or two abdominal quadrants out of four: upper left, upper right, lower left or lower right). Actually, there is no official definition of what a localized CAA is, however Ross (J.Ross. Secondary peritonitis: principles of diagnosis and intervention, BMJ. 2018; 361) define localized peritonitis as infection to one or two quadrants out of four (upper left, upper left, lower left or lower right)
2. Laparoscopic appendectomy
3. Aged 18 or over
4. signed ICF

Exclusion criteria 17

1. Patients with cardiac valvulopathy
2. Immunodepressed patients
3. Diabetic patients
4. Patients who have received an antibiotic treatment within 3 months before the surgery (and having a potential impact on the intestinal flora)
5. other diseases (Crohn’s disease, ulcerative colitis, treatment with an immunosuppressive therapy)
6. Severe sepsis, septic shock or generalized peritonitis.
7. a) A decision to perform open appendectomy.
8. b) Patients who received an adaptive dose of Levofloxacine 250 mg/24H instead of 500 mg/24H in pre-operative or in per-operative (notably for patients with creatinine clearance ≤ 50 ml/min)
9. allergy to metronidazole or to one of the excipient
10. d) Contra-indication to the use of ceftriaxone (hypersensibility to the active substance, to another cephalosporin, to the excipient of the used speciality), history of severe hypersesibility (as anaphylactic shock), history of hypersensibility to another antibiotic of the beta-lactamin family (penicillin, monobactam, carbapénèmes)
11. e) Contra-indication to the use of levofloxacin, hypersensibility to levofloxacin, to another quinolone or to the excipient of one of the use speciality, hypersensibility to levofloxacine ou any other quinolone or to any excipient, epilepsia, history of tendinitis when injection of fluoroquinolones
12. Living at more than one hour from an hospital
13. b) Patient who has no relative or other third person who could be present at home and provide assistance in case of any problem for the discharged patient
14. Non-complicated forms (catarrhal appendicitis or the absence of extraluminal fecaliths, abscess or peritonitis).
15. Generalized purulent or stercoral peritonitis (the presence of pus or faeces in more than two quadrants of the abdomen out of four).
16. Pregnancy or breastfeeding.
17. Patient under guardianship

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. proportion of patients with deep SSIs by POD30. Deep SSIs are officially defined by the centre of disease control and prevention (CDC) (29) as infections that occur within 30 days of surgery AND appear to be related to the surgery AND affect the organ or the cavity around the surgical site (i.e. any anatomical structure – other than the incision – that is opened or handled during surgery) AND for which at least one sign defined in the protocol is observed

Secondary endpoints 9

1. Quality of life prior to surgery and on discharge, using the SF36 questionnaires.
2. The proportion of patients with superficial SSIs
3. The post-operative infection rates by POD30, including SSIs and remote infections
4. The number of antibiotic-free days between randomization and POD30.
5. The description of the microbial flora, as found in the antibiogram of the per-operative sample that is collected in all cases
6. The balance between antibiotic therapy and microbial resistance. The antibiotic treatment will be considered to be adequate if no germs are found in the per-operative sample or if all of the detected germs are sensitive to the administered antibiotic therapy. The antibiotic treatment will be considered to be inadequate if the per-operative sample is positive for resistant germs
7. Morbidity and mortality according to the Dindo-Clavien classification (31) and the CCI, Slankamenac, Ann Surg, 2014; 260:757-62) (32)
8. LOS, defined as the number of days of hospitalization between surgery and discharge
9. The rehospitalization rate, defined as rehospitalization during the study period

Investigational products

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

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Amiens Picardie

Sponsor organisation

Centre Hospitalier Universitaire Amiens Picardie

Address

1 Rond Point Du Pr Christian Cabrol

City

Amiens Cedex 1

Postcode

80054

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Boussault

Public contact point

Organisation

Centre Hospitalier Universitaire Amiens Picardie

Contact name

Boussault

Locations

1 EU/EEA country · 19 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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