Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery

Bladder Cancer Clinical Trial

— MACS  

Official title:

Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05392634
• Other study ID #: MACS-1
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: May 2022
• Source: N.N. Petrov National Medical Research Center of Oncology
• Contact: Mariya Berkut, PhD
• Phone: +79312870497
• Email: berkutv91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current usage of antibiotic prophylaxis (AP) in radical cystectomy (RC) is aimed to reducing the incidence of surgical site infections and incidence of unnecessary prescribing of antibiotics. There are a huge number of different AP protocols according to Urological Associations. However, there is no convincing evidence to support variations and duration of AP which requires a randomized clinical trial on AP when performing variants of RC with uroderivation.

Research hypothesis: The use of prolonged antibiotic prophylaxis (5 days), depending on the glomerular filtration rate, does not affect the incidence of postoperative complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: November 1, 2023
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• histologically confirmed diagnosis of very high risk non muscle-invasive bladder carcinoma (cT1NoMo) or muscle-invasive bladder carcinoma (cT2-T4NxM0) with or without neoadjuvant therapy (chemotherapy or immunotherapy are both possible);

• patient should be eligible for radical cystectomy (RC) + pelvic lymph node dissection (PLND), and agreement to undergo curative intent standard RC + PLND (including prostatectomy or hysterectomy if applicable) according to surgeon opinion;

• pelvic lymph node dissection is engaged in two possible variants: extended level to intersection of ureter and iliac vessels; superextended level - up to aortic bifurcation;

• urinary diversion is engaged in two possible variants: orthotopic diversion (J- or U-pouch reservoirs), heterotopic diversion in the Mainz-I modification, Bricker;

• male or female is at least 18 years old at the time of signing the informed consent form;

• female patient is eligible to participate if she is not pregnant, not breastfeeding;

• ECOG performance status of 0 or 1;

• adequate organ function (in accordance with laboratory standards);

• used valid protocol for Enhanced Recovery After Surgery (ERAS protocol) at Hospital (oncourological department);

Exclusion Criteria:

• known additional non-urothelial malignancy that is progressing or has required active anticancer treatment =3 years of study randomization, with certain exceptions;

• diagnosis of immunodeficiency or receipt of chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug;

• replacement doses of corticosteroids are permitted for participants with adrenal insufficiency;

• evidences of uncontrolled diseases (diabetes mellites, noninfectious pneumonitis that required steroids, et.) or any conditions which interfere with the conduct of the research procedures according to doctor opinion;

• presence of 2 or more criteria for systemic inflammatory response syndrome (SIRS) at the time of the patient's admission to the hospital (assessment of these factors 3-7 days before randomization):

• temperature = 38°? or = 36°?;

• heart rate (HR) = 90 / min;

• respiratory rate < 20/min or hyperventilation (Pa CO2 = 32 mm Hg);

• blood leukocytes >12 · 109 / l or < 4 · 109 / l, or immature forms > 10%

• prohibited urinary diversion when planning surgery and signing voluntary consent:

diversion into continuous intestine (ureterosigmostomy, Mainz-pouch II operation);

• inadequate organ function:

• Neutrophils <1.5 x 10 ^ 9 / l

• Platelets <100 x 10 ^ 9 / l

• ALT> 3 x VGN

• AST> 3 x VGN

• Bilirubin> 1.5 x ULN

• GFR level <35 ml / min

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Meropenem 1000 mg
Group B: prolonged antibiotic prophylaxis >72 hours (5 days) from the moment of the skin incision in accordance with the selected clinic drug + correction of the appointment based on clinical events after 5 days.
• Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg
Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;

Locations

Country	Name	City	State
Russian Federation	FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation	Saint Petersburg	?????-?????????

Sponsors (2)

Lead Sponsor	Collaborator
N.N. Petrov National Medical Research Center of Oncology	The Foundation for Cancer Research Support (RakFond)

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate	Determine the frequency of events of clinical interest in the period 30-90 days after RC in a surgical hospital working according to the protocol for early postoperative recovery of the patient	90 days after Radical cystectomy
Primary	Event-free survival	Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital	90 days after Radical cystectomy
Secondary	Emergence of resistant	To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis	30-90 days after Radical cystectomy
Secondary	All-cause mortality	Establish the frequency of 30-day, 90-day all-cause mortality after RC in a surgical hospital working according to the protocol for early postoperative patient recovery	90 days after Radical cystectomy