Preoperative Antibiotics for Mild or Moderate Acute Cholecystitis (POMMAC): A Non-inferiority, Open-label, Randomized Controlled Trial – Study Protocol

2024-515958-24-00 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 25 Aug 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 3 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 456
Countries 1
Sites 3

Acute cholecystitis

To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of postoperative infectious complications in patients undergoing cholecystectomy for acute cholecystitis.

Key facts

Sponsor
HUS-Yhtymae
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Digestive System Diseases [C06]
Trial duration
25 Aug 2025 → ongoing
Decision date (initial)
2025-04-07
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy

To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of postoperative infectious complications in patients undergoing cholecystectomy for acute cholecystitis.

Secondary objectives 4

  1. To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the conversion rate from laparoscopic to open cholecystectomy during the primary operation in patients undergoing cholecystectomy for acute cholecystitis.
  2. To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of all postoperative complications in patients undergoing cholecystectomy for acute cholecystitis
  3. To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the rate of all antibiotic-related adverse outcomes (hypersensitivity reactions, clostridium difficile diarrhea, yeast infections) within 30 days postoperatively in patients undergoing cholecystectomy for acute cholecystitis
  4. To compare the effect of a single-dose of antibiotics versus continuous antibiotics preoperatively on the length of stay in patients undergoing cholecystectomy for acute cholecystitis

Conditions and MedDRA coding

Acute cholecystitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Patients with diagnosed mild or moderate acute cholecystitis (according to Tokyo Guidelines)

Exclusion criteria 11

  1. Age under 18 years
  2. subjects with reduced capacity for self-determination
  3. Pregnancy
  4. Peritonitis
  5. Suspicion of cholangitis (Charcot's triad or radiologic findings)
  6. Bile duct stones
  7. Allergy to all antibiotics in protocol
  8. Antibiotics 24 hours prior to randomisation
  9. Breastfeeding women
  10. Class D drug-drug interactions
  11. Tokyo Guidelines Grade III cholecystitis (see protocol)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The rate of postoperative infectious complications within 30 days from randomisation

Secondary endpoints 4

  1. The conversion rate from laparoscopic to open cholecystectomy during the primary operation
  2. The Comprehensive Complication Index according to the Clavien-Dindo Classification within 30 days postoperatively
  3. A composite outcome incorporating the rate of all antibiotic-related adverse outcomes (hypersensitivity reactions, clostridium difficile diarrhea, yeast infections) within 30 days postoperatively
  4. The length of stay

Investigational products

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

Test 3

INVANZ 1 g powder for concentrate for solution for infusion

PRD2821997 · Product

Active substance
Ertapenem
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 Bq/Aµl becquerel(s)/microlitre
Max total dose
7 g/l gram(s)/litre
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
J01DH03 — -
Marketing authorisation
EU/1/02/216/001
MA holder
MERCK SHARP & DOHME B.V.
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ciprofloxacin Fresenius Kabi 2 mg/ml infuusioneste, liuos

PRD408967 · Product

Active substance
Ciprofloxacin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
1 g gram(s)
Max total dose
7 g gram(s)
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
J01MA02 — CIPROFLOXACIN
Marketing authorisation
21759
MA holder
FRESENIUS KABI AB
MA country
Finland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cefuroxime Orion Pharma 1,5 g injektio/infuusiokuiva-aine, liuosta/suspensiota varten

PRD542415 · Product

Active substance
Cefuroxime
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS
Max daily dose
4.5 Bq/Aµl becquerel(s)/microlitre
Max total dose
32 g/l gram(s)/litre
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
J01DC02 — -
Marketing authorisation
17382
MA holder
ORION CORPORATION
MA country
Finland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HUS-Yhtymae

30 Total trials 12 Recruiting 5 Ended
Academic / Non-commercial
Sponsor organisation
HUS-Yhtymae
Address
Stenbackinkatu 9
City
Helsinki
Postcode
00290
Country
Finland

Scientific contact point

Organisation
HUS-Yhtymae
Contact name
Panu Mentula

Public contact point

Organisation
HUS-Yhtymae
Contact name
Panu Mentula

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Finland Ongoing, recruiting 456 3
Rest of world — 0 —

Investigational sites

Finland

3 sites · Ongoing, recruiting
HUS-Yhtymae
Hyvinkää Hospital, Stenbackinkatu 9, 00290, Helsinki
HUS-Yhtymae
Meilahti Hospital, Stenbackinkatu 9, 00290, Helsinki
HUS-Yhtymae
Jorvi Hospital, Stenbackinkatu 9, 00290, Helsinki

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Finland 2025-08-25 2025-08-25

Results and documents

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

Documents 13 files

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

TypeTitleVersion
Protocol (for publication) ab_plan_cholecystitis_1410 1
Protocol (for publication) ab_plan_cholecystitis_1512 2.1
Protocol (for publication) ab_plan_cholecystitis_1911 1
Protocol (for publication) ab_plan_cholecystitis_1911_track_changes 1.1
Recruitment arrangements (for publication) recruitment arrangements0304 1.1
Subject information and informed consent form (for publication) suostumus_pommac0703_track_changes 1.1
Subject information and informed consent form (for publication) suostumus_pommac0803 1.1
Subject information and informed consent form (for publication) TIEDOTE TUTKIMUKSESTA_pommac_0703_track_changes 1.1
Subject information and informed consent form (for publication) TIEDOTE TUTKIMUKSESTA_pommac0304 2.1
Summary of Product Characteristics (SmPC) (for publication) ciprofloxacin 2
Summary of Product Characteristics (SmPC) (for publication) invanz 2
Summary of Product Characteristics (SmPC) (for publication) kefuroksiimi 1
Synopsis of the protocol (for publication) ABSTRACT_pommac 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-24 Finland Acceptable
2024-12-18
 2025-04-07
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-04-09 Finland Acceptable
2024-12-18
 2025-04-09
3 NON SUBSTANTIAL MODIFICATION NSM-2 2025-10-14 Finland Acceptable
2024-12-18
 2025-10-14
4 SUBSTANTIAL MODIFICATION SM-1 2025-10-14 Finland Acceptable
2025-11-27
 2025-11-27
5 NON SUBSTANTIAL MODIFICATION NSM-5 2025-11-28 Finland Acceptable
2025-11-27
 2025-11-28
6 NON SUBSTANTIAL MODIFICATION NSM-6 2025-12-05 Finland Acceptable
2025-11-27
 2025-12-05

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