Bladder CancerPhase 3MACSNCT05392634
Multicentral Preventive Antibiotics With Cystectomy Within Enhanced Recovery After Surgery
A Phase 3 study testing Meropenem 1000 mg and Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg in people with Bladder Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Meropenem 1000 mg and Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteRussia
- Study dates
- 2 Feb 2022to 1 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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);
Who cannot join
- 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˚С or ≤ 36˚С;
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
Saint Petersburg, Sankt-Peterburg, 197758
Mariya Berkut, PhD, 89312870497, berkutv91@gmail.com
About this study
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
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.
- Conditions
- Bladder Cancer
- Being tested
- Meropenem 1000 mg, Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg
- Keywords
- radical cystectomy, antibiotic prophylaxis, ERAS protocol, muscle-invasive bladder cancer, urinary diversion
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem 1000 mgDrug
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 1500mgDrug
Group A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice;
| Study group | Role | What they receive |
|---|---|---|
| Amoxicillin/ Cefuroksim | Active comparator | standard antibiotic prophylaxis 24 hours Receives: Drug: Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg |
| Meropenem | Experimental | preventive antibiotic therapy within 5 days from the date of the skin incision Receives: Drug: Meropenem 1000 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days after Radical cystectomy
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
Measured: 90 days after Radical cystectomy
Secondary outcomes (2)
Emergence of resistant
To assess the probability of occurrence of acquired carbapenemase against the background of prolonged antibiotic prophylaxis
Measured: 30-90 days after Radical cystectomy
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
Measured: 90 days after Radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start2 Feb 2022
- Primary completion2 Feb 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.N. Petrov National Medical Research Center of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- The Foundation for Cancer Research Support (RakFond)
- Responsible party
- Principal investigator, Berkut Mariya, N.N. Petrov National Medical Research Center of Oncology
- Investigators
- Mariya Berkut, PhD, Principal investigator, FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392634
- Sponsor's protocol ID
- MACS-1
- Acronym
- MACS
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berkut MV, Belyaev AM, Galunova TY, Tyapkin NI, Reva SA, Nosov AK. Prolonged 120-h meropenem antibiotic prophylaxis in radical cystectomy compared to 24h standard antibiotic prophylaxis: Final analysis of the randomized clinical trial. Arab J Urol. 2024 Jul 3;22(4):235-242. doi: 10.1080/20905998.2024.2373399. eCollection 2024.
PubMed 39355793
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05392634
- Acronym / sponsor ID
- MACS / MACS-1
- Conditions
- Bladder Cancer
- Keywords
- radical cystectomy, antibiotic prophylaxis, ERAS protocol, muscle-invasive bladder cancer, urinary diversion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
- Collaborators
- The Foundation for Cancer Research Support (RakFond)
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amoxicillin/ Cefuroksim | Active comparator | Drug: Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mgstandard antibiotic prophylaxis 24 hours |
| Meropenem | Experimental | Drug: Meropenem 1000 mgpreventive antibiotic therapy within 5 days from the date of the skin incision |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem 1000 mgGroup 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. | Drug | Meropenem |
| Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mgGroup A: antibiotic prophylaxis within 24 hours from the moment of skin incision according to local clinical practice; | Drug | Amoxicillin/ Cefuroksim |
Primary outcome
Event rate
Time frame: 90 days after Radical cystectomy
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
Event-free survival
Time frame: 90 days after Radical cystectomy
Estimate the time to development of events of clinical interest in the period 30-90 days after RC in a surgical hospital
2 secondary outcomes
Emergence of resistant
Time frame: 30-90 days after Radical cystectomy
All-cause mortality
Time frame: 90 days after Radical cystectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 39355793Berkut MV, Belyaev AM, Galunova TY, Tyapkin NI, Reva SA, Nosov AK. Prolonged 120-h meropenem antibiotic prophylaxis in radical cystectomy compared to 24h standard antibiotic prophylaxis: Final analysis of the randomized clinical trial. Arab J Urol. 2024 Jul 3;22(4):235-242. doi: 10.1080/20905998.2024.2373399. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariya Berkut, PhD principal investigator
FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meropenem 1000 mg and Amoxicillin+clavulanic acid 1200 mg or Cefuroksim 1500mg in people with Bladder Cancer, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariya Berkut, PhD (+79312870497, berkutv91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event rate (time frame: 90 days after Radical cystectomy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05392634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.