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Cardiac Implantable Electronic Device InfectionsORI-4-CIEDiNCT07013552

Oritavancin for CIED Infections With MDR Gram-positive Cocci

A study testing Administration of a single or repeated dose of a long half-life antibiotic - oritavancin and Administration of a repeated dose of a short half-life antibiotic - vancomycin in people with Cardiac Implantable Electronic Device Infections and Infective Endocarditis, run by Medical University of Silesia at 1 site in Poland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Administration of a single or repeated dose of a long half-life antibiotic - oritavancin and Administration of a repeated dose of a short half-life antibiotic - vancomycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePoland
Study dates
Jun 2025to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Completed 18 years of age
  • Presence of signs and symptoms of superficial ABSSSI or PI in the form of a) redness/warmth/swelling/pain or b) separation of the edges of the surgical incision with signs of inflammation or the need for repeated surgical debridement of the wound or c) the presence of decubitus of the skin and subcutaneous tissue in area of the generator or skin abscess/erosion of the device pocket, with purulent discharge from the wound or discharge giving a positive microbial culture
  • Probable/ definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)
  • Suspected/confirmed infection with drug-resistant Gram-positive cocci, i.e., Staphylococcus spp. (Stahphylococcus aureus or coagulase-negative staphylococci), Streptococcus spp. or Enterococcus spp. sensitive to oritavancin
  • Suspected/confirmed infection with Gram-positive cocci, i.e., Staphylococcus spp., Streptococcus spp., Enterococcus spp., sensitive to vancomycin or oritavancin and beta-lactam antibiotics in patients with a history of type I anaphylaxis to penicillin.

Who cannot join

  • Suspected/confirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria
  • Suspected/confirmed community-acquired infection or infection with Gram-positive cocci sensitive to betalactam antibiotics, including penicillin, ampicillin, or methicillin, based on empirical data or cultures (does not apply to patients with a history of type I anaphylaxis to penicillin)
  • Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.
  • History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)
  • History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)
  • No possibility of temporarily interrupting/initiating alternative therapy to intravenous infusion of unfractionated heparin
  • Pregnancy or breastfeeding
  • Lack of informed written consent of the patient to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Danuta Loboda, MD, PhD contact

(+48) 32 359-89-90

dloboda@sum.edu.pl

Beata Sarecka-Hujar, Professor contact

bsarecka-hujar@sum.edu.pl

Poland1 site

  • Department of Electrocardiology and Heart Failure, Medical University of Silesia in Katowice

    Katowice, Silesian Voivodeship, 40-635

Other trials in Poland

About this study

Official title: Oritavancin as a Therapeutic Regimen for Cardiac Implantable Electronic Devices Infections With Multidrug-resistant Gram-positive Cocci

The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.

Read the detailed description

Study Objectives:

This study's purpose is to evaluate the safety and efficacy of two antibiotic dosage regimens in a pilot study of cardiac implantable electronic devices (CIED) infections with multidrug-resistant (MDR) Gram-positive cocci.

Study Design:

This study is a single-center randomized, non-inferiority, control trial comparing the efficacy and safety of two antibiotic dosage regimens with a long-half-life antibiotic (oritavancin, experimental group) vs. standard therapy with a short-half-life antibiotic (vancomycin, control group).

Study Assumptions:

The investigators assumed that the efficacy of oritavancin therapy administered as a single intravenous infusion (for surgical incision site infection or pocket infection) or in fractionated doses administered at seven-day intervals (for lead-related infectious endocarditis) would be non-inferior to the efficacy of standard vancomycin therapy administered daily at 8-12 hour intervals and that there would be no difference in the safety profile between the two therapies.

Patient Population:

Patients aged ≥18 with CIED surgical incision site infection (i.e., superficial acute bacterial skin and skin structure infections, ABSSSI) or deep infections of the generator pocket (PI) complicated or not with lead-related infectious endocarditis (LRIE) (optional) with multidrug-resistant (MDR) Gram-positive cocci.

The planned size of the group in the pilot study is 50-100. The planned recruitment period is 15 months, and the observation period is 3 months.

Once all inclusion criteria and none of the exclusion criteria are met, patients who have given written informed consent to participate in the study will be randomly assigned to the experimental group and the control group to achieve a 1:1 group size ratio.

Intervention:

The diagnostic and surgical approach and the duration of antibiotic treatment will be determined depending on the etiological factor and clinical indications by the consensus of European Heart Rhythm Association and Heart Rhythm Society experts on cardiovascular implantable electronic device lead management and extraction and the European Society of Cardiology guidelines for the treatment of infective endocarditis.

The intervention under investigation (experimental) will be administering a single or repeated dose of oritavancin.

The standard intervention will be administering of repeated doses of vancomycin.

Experimental group - Oritavancin dosage:

  1. in superficial ABSSSI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
  2. in isolated PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml);
  3. in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution (infusion volume: 1,000 ml), subsequent doses of 800 mg (2 vials) administered as a 2-3 hour intravenous infusion at 7-day intervals, to achieve the required duration of drug therapy of 2-6 weeks (counted from the day of TLE).

Control group - Vancomycin dosage:

  1. in superficial ABSSSI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 7-10 days (calculated from the beginning of antibiotic therapy, not less than seven days from surgical tissue debridement, if required);
  2. in isolated PI: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, for 10-14 days (counted from the day of surgical debridement of the generator pocket and TLE, if possible);
  3. in LRIE: Repeated doses of 15-20 mg/kg body weight every 8-12 hours (maximum 3,000 mg/day for patients with normal renal function) administered as an hourly intravenous infusion in 0.9% sodium chloride solution (infusion volume: 500-1,000 ml), under monitoring the drug concentration in serum, to achieve the required pharmacotherapy time of 2-6 weeks (counted from the day of surgical debridement of the incision site and TLE).

Observation:

Observation will include

  1. Physical examination with the assessment of the CIED implantation site;
  2. Routine laboratory tests, including blood count, C-reactive protein (mg/l), procalcitonin (ng/ml), plasma creatinine (mg/dl);
  3. Transthoracic echocardiogram with the assessment of bacterial vegetations;
  4. Transesophageal echocardiogram with the assessment of bacterial vegetations, with particular emphasis on the tricuspid valve and CIED leads;
  5. PET/CT examination with 18F-FDG or SPECT/CT using radioisotope-labeled leukocytes (depending on clinical indications).

Evaluation will be performed at 72-120 hours of therapy, after 5-7 and 14 days of therapy, and after 1 and 3 months of therapy, with endpoints assessed at 3 months.

Primary endpoints will include a complete cure rate and serious treatment-related adverse events at 3 months of follow-up.

Secondary endpoints will include clinical response rates, worsening or recurrence of infection despite drug therapy (including those resulting in rehospitalization and requiring alternative antibiotic therapy), and time to clinical response.

Being tested
Administration of a single or repeated dose of a long half-life antibiotic - oritavancin, Administration of a repeated dose of a short half-life antibiotic - vancomycin
Keywords
Cardiac implantable electronic device, Gram-positive cocci, Health-care associated infections, Lead-related infective endocarditis, Multidrug-resistant bacteria, Pocket infection
Medical subject headings
Endocarditis, Gram-Positive Bacterial Infections, Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Administration of a single or repeated dose of a long half-life antibiotic - oritavancinDrug

    Intravenous administration of a single or repeated dose of lipoglycopeptide antibiotic - oritavancin.

    In superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution.

    In LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion in 5% glucose solution, subsequent doses of 800 mg (2 vials) administered as a 2-3 hour intravenous infusion at 7-day intervals, to achieve the required duration of drug therapy of 2-6 weeks (counted from the day of transvenous lead extraction).

  • Administration of a repeated dose of a short half-life antibiotic - vancomycinDrug

    Intravenous administration of repeated doses of glycopeptide antibiotic - vancomycin.

    Repeated doses of 15-20 mg/kg body weight every 8-12 hours administered as an hourly intravenous infusion in 0.9% sodium chloride solution, under monitoring the drug concentration in serum, for 7-10 days in ABSSSI, for 10-14 days in PI, and for 2-6 weeks in LRIE (counted from the day of transvenous lead extraction).

Study groups in NCT07013552
Study groupRoleWhat they receive
Patients treated with a long half-life antibiotic - oritavancin (Tenkasi)ExperimentalPatients with CIED infection with MDR Gram-positive cocci treated with a long half-life lipoglycopeptide antibiotic - oritavancin
Receives: Drug: Administration of a single or repeated dose of a long half-life antibiotic - oritavancin
Patients treated with a short half-life antibiotic - vancomycin (Vancomycin)Active comparatorPatients with CIED infection with MDR Gram-positive cocci treated with a short half-life glycopeptide antibiotic - vancomycin
Receives: Drug: Administration of a repeated dose of a short half-life antibiotic - vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-primary efficacy endpoint - treatment success rate

    Treatment success will be defined as obtaining a clinical response and no recurrence of infection at the same site or the site of CIED reimplantation within three months of F/U.

    Measured: 3 months

  2. Co-primary safety endpoint - no treatment-related Serious Adverse Events

    Any adverse event classified as grade 3-5 according Health Technology Assessment report developed by the Agency for Health Technology Assessment and Tariff System (Poland) and related to using the investigational product (scores of 3-5) will be counted as a safety endpoint.

    Measured: 3 months

Secondary outcomes (6)

  1. Clinical response rate

    Clinical response will be defined as follows:

    1. In the case of ABSSSI: a reduction in the size of the inflammatory lesion by at least 20% compared to the baseline after 48-72 hours of antibiotic therapy (in the case of conservative treatment) or the resolution of ABSSSI/complete healing of the surgical wound assessed after 7-10 days.
    2. In the case of isolated PI: a resolution of fever and reduction of inflammatory parameters by ≥50% after 72-120 hours of antibiotic therapy and complete healing of the surgical wound assessed after 10-14 days.
    3. In the case of PI complicated by LRIE: a reduction of inflammatory parameters by ≥50% after 72-120 hours of antibiotic therapy, negative control blood cultures after 72 hours, and resolution of fever by the 7th day, complete healing of the surgical wound after 10-14 days and resolution and absence of new echocardiographic signs of infection after the end of antibiotic therapy.

    Measured: 3 months

  2. Median time to clinical response

    Median time to clinical response defined as above and given in hours or days (as required).

    Measured: 3 months

  3. Recurrent infection rate

    Recurrence of infection will be defined as CIED infection occurring within three months of the completion of previous treatment, caused by the persistence of bacteria with the same phenotype in the skin and subcutaneous tissue, the device pocket, intracardiac leads, the right-sided endocardium or tricuspid valve.

    Measured: 3 months

  4. Rehospitalization rate due to recurrent infection

    Hospitalization due to recurrent infection will be defined as a hospital stay resulting from the need for repeated antibiotic administration or repeated surgical intervention related to recurrent infection in the form of ABSSSI, PI, or LRIE (as outlined in point 5).

    Measured: 3 months

  5. Proportion of cases in which infection worsened from superficial or local to systemic despite drug therapy

    A case in which an infection escalates from superficial or localized to systemic despite receiving drug therapy will be defined as a situation in which, after performing all planned initial tests, including transesophageal echocardiography and blood cultures, ABSSSI or PI will be diagnosed. However, during further follow-up, new clinical symptoms, laboratory tests, or imaging studies will indicate the development of LRIE.

    Measured: 3 months

  6. Proportion of cases in which alternative "rescue" antibiotic therapy was used due to treatment failure

    Treatment failure was defined as a lack of clinical response or worsening of infection despite adequate antibiotic therapy and surgical treatment (if necessary) or the need for alternative "rescue" antibiotic therapy.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized 1:1 to the intervention and control groups. Experimental group: Oritavancin dosage in superficial ABSSSI or PI: Single dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion. Oritavancin dosage in LRIE: First dose of 1,200 mg (3 vials) administered as a 3-hour intravenous infusion, subsequent doses of 800 mg (2 vials) administered as a 2-3 hour intravenous infusion at 7-day intervals, to achieve the required duration of drug therapy of 2-6 weeks (counted from the day of transvenous lead extraction). Control group: Vancomycin dosage: Repeated doses of 15-20 mg/kg body weight every 8-12 hours administered as an hourly intravenous infusion for 7-10 days in ABSSSI, for 10-14 days in PI, and for 2-6 weeks in LRIE.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013552
Sponsor's protocol ID
KPOD.07.07-IW.07-0004/24
Acronym
ORI-4-CIEDi
Status last verified
Jun 2025
First submitted
12 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The raw IPD data that underlie results in a publications will be openly available.

Publications

  • Gladysz-Wanha S, Joniec M, Wanha W, Pilat E, Drzewiecka A, Gardas R, Biernat J, Weglarzy A, Golba KS. Transvenous lead extraction safety and efficacy in infected and noninfected patients using mechanical-only tools: Prospective registry from a high-volume center. Heart Rhythm. 2024 Apr;21(4):427-435. doi: 10.1016/j.hrthm.2023.12.015. Epub 2023 Dec 28.

    PubMed 38157921

  • Olsen T, Jorgensen OD, Nielsen JC, Thogersen AM, Philbert BT, Johansen JB. Incidence of device-related infection in 97 750 patients: clinical data from the complete Danish device-cohort (1982-2018). Eur Heart J. 2019 Jun 14;40(23):1862-1869. doi: 10.1093/eurheartj/ehz316.

    PubMed 31155647

  • Stewart CL, Turner MS, Frens JJ, Snider CB, Smith JR. Real-World Experience with Oritavancin Therapy in Invasive Gram-Positive Infections. Infect Dis Ther. 2017 Jun;6(2):277-289. doi: 10.1007/s40121-017-0156-z. Epub 2017 Apr 6.

    PubMed 28386776

  • Morrisette T, Miller MA, Montague BT, Barber GR, McQueen RB, Krsak M. On- and off-label utilization of dalbavancin and oritavancin for Gram-positive infections. J Antimicrob Chemother. 2019 Aug 1;74(8):2405-2416. doi: 10.1093/jac/dkz162.

    PubMed 31322694

  • Rubino CM, Bhavnani SM, Moeck G, Bellibas SE, Ambrose PG. Population pharmacokinetic analysis for a single 1,200-milligram dose of oritavancin using data from two pivotal phase 3 clinical trials. Antimicrob Agents Chemother. 2015;59(6):3365-72. doi: 10.1128/AAC.00176-15. Epub 2015 Mar 30.

    PubMed 25824211

  • Carvalhaes CG, Sader HS, Streit JM, Castanheira M, Mendes RE. Activity of Oritavancin against Gram-Positive Pathogens Causing Bloodstream Infections in the United States over 10 Years: Focus on Drug-Resistant Enterococcal Subsets (2010-2019). Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0166721. doi: 10.1128/AAC.01667-21. Epub 2021 Nov 22.

    PubMed 34807761

  • Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N; WHO Pathogens Priority List Working Group. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 Mar;18(3):318-327. doi: 10.1016/S1473-3099(17)30753-3. Epub 2017 Dec 21.

    PubMed 29276051

  • Lupia T, De Benedetto I, Bosio R, Shbaklo N, De Rosa FG, Corcione S. Role of Oritavancin in the Treatment of Infective Endocarditis, Catheter- or Device-Related Infections, Bloodstream Infections, and Bone and Prosthetic Joint Infections in Humans: Narrative Review and Possible Developments. Life (Basel). 2023 Apr 6;13(4):959. doi: 10.3390/life13040959.

    PubMed 37109488

  • Thomas G, Henao-Martinez AF, Franco-Paredes C, Chastain DB. Treatment of osteoarticular, cardiovascular, intravascular-catheter-related and other complicated infections with dalbavancin and oritavancin: A systematic review. Int J Antimicrob Agents. 2020 Sep;56(3):106069. doi: 10.1016/j.ijantimicag.2020.106069. Epub 2020 Jun 27.

    PubMed 32603683

  • Esposito S, Blasi F, Curtis N, Kaplan S, Lazzarotto T, Meschiari M, Mussini C, Peghin M, Rodrigo C, Vena A, Principi N, Bassetti M. New Antibiotics for Staphylococcus aureus Infection: An Update from the World Association of Infectious Diseases and Immunological Disorders (WAidid) and the Italian Society of Anti-Infective Therapy (SITA). Antibiotics (Basel). 2023 Apr 12;12(4):742. doi: 10.3390/antibiotics12040742.

    PubMed 37107104

  • Corey GR, Arhin FF, Wikler MA, Sahm DF, Kreiswirth BN, Mediavilla JR, Good S, Fiset C, Jiang H, Moeck G, Kabler H, Green S, O'Riordan W; SOLO I, SOLO II Investigators. Pooled analysis of single-dose oritavancin in the treatment of acute bacterial skin and skin-structure infections caused by Gram-positive pathogens, including a large patient subset with methicillin-resistant Staphylococcus aureus. Int J Antimicrob Agents. 2016 Nov;48(5):528-534. doi: 10.1016/j.ijantimicag.2016.07.019. Epub 2016 Sep 13.

    PubMed 27665522

  • Giske CG, Turnidge J, Canton R, Kahlmeter G; EUCAST Steering Committee. Update from the European Committee on Antimicrobial Susceptibility Testing (EUCAST). J Clin Microbiol. 2022 Mar 16;60(3):e0027621. doi: 10.1128/JCM.00276-21. Epub 2021 Aug 4.

    PubMed 34346716

  • Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available.

    PubMed 37622656

  • Milman A, Wieder-Finesod A, Zahavi G, Meitus A, Kariv S, Shafir Y, Beinart R, Rahav G, Nof E. Complicated Pocket Infection in Patients Undergoing Lead Extraction: Characteristics and Outcomes. J Clin Med. 2023 Jun 29;12(13):4397. doi: 10.3390/jcm12134397.

    PubMed 37445433

  • Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.

    PubMed 28919379

Questions about this trial

What is this clinical trial studying?

A study testing Administration of a single or repeated dose of a long half-life antibiotic - oritavancin and Administration of a repeated dose of a short half-life antibiotic - vancomycin in people with Cardiac Implantable Electronic Device Infections and Infective Endocarditis, run by Medical University of Silesia at 1 site in Poland.

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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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 Poland. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Danuta Loboda, MD, PhD ((+48) 32 359-89-90, dloboda@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Co-primary efficacy endpoint - treatment success rate (time frame: 3 months). 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 NCT07013552, which also lists 21 linked publications.

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 10 Jun 2025.

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