Complicated Urinary Tract InfectionPhase 3Integral-1NCT05887908
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
A Phase 3 study testing co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam and imipenem/cilastatin in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Meiji Seika Pharma Co., Ltd. at 61 sites in 9 countries.
Trial summary
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI
- What is being tested?
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam and imipenem/cilastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 61 sitesin 9 countries
- Study dates
- 23 May 2023to 26 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;
- Weight at most 140 kg;
- Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;
Who cannot join
- Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion.
- Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion.
- Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;
Trial locations and contacts
61 sites in 9 countries.
61 sites in 9 countries
Japan20 sites
Meiji Research Site
Fukuyama
Meiji Research Site
Gifu
Meiji Research Site
Ibaraki-Town, Higashiibaraki-County
Meiji Research Site
Iwakuni
Meiji Research Site
Kanazawa
Meiji Research Site
Kawachi-Nagano
Meiji Research Site
Kofu
Meiji Research Site
Kumamoto
Meiji Research Site
Matsumoto
Meiji Research Site
Mizumaki-Town, Onga-County
Meiji Research Site
Nagasaki
Meiji Research Site
Nankoku
Meiji Research Site
Ōita
Meiji Research Site
Ōtake
Meiji Research Site
Sagamihara
Meiji Research Site
Sapporo
Meiji Research Site
Shinjuku-ku
Meiji Research Site
Toyota
Meiji Research Site
Ueda
Meiji Research Site
Yokohama
China19 sites
Meiji Research Site
Beijing
Meiji Research Site
Changchun
Meiji Research Site
Chongqing
Meiji Research Site
Fuyang
Meiji Research Site
Ganzhou
Meiji Research Site
Huaian
Meiji Research Site
Huzhou
Meiji Research Site
Nanchang
Meiji Research Site
Nanning
Meiji Research Site
Quanzhou
Meiji Research Site
Shanghai
Meiji Research Site
Shantou
Meiji Research Site
Shijiazhuang
Meiji Research Site
Taian
Meiji Research Site
Tianjin
Meiji Research Site
Xuancheng
Meiji Research Site
Yunnan
Meiji Research Site
Zhejiang
Meiji Research Site
Zhengzhou
Bulgaria4 sites
Meiji Research Site
Pleven
Meiji Research Site
Rousse
Meiji Research Site
Silistra
Meiji Research Site
Sofia
Czechia4 sites
Meiji Research Site
Hradec Králové
Meiji Research Site
Liberec
Meiji Research Site
Prague
Meiji Research Site
Ústí nad Labem
Estonia4 sites
Meiji Research Site
Kohtla-Järve
Meiji Research Site
Meegomäe, Võrumaa
Meiji Research Site
Tallinn
Meiji Research Site
Tartu
Georgia3 sites
Meiji Research Site
Kutaisi
Meiji Research Site
Rustavi
Meiji Research Site
Tbilisi
Slovakia3 sites
Meiji Research Site
Galanta
Meiji Research Site
Rimavská Sobota
Meiji Research Site
Svidník
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
- Being tested
- co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam, imipenem/cilastatin
- Keywords
- OP0595, nacubactam, Integral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
co-administration of cefepime and nacubactamDrug
2 g cefepime and 1 g nacubactam
co-administration of aztreonam and nacubactamDrug
2 g aztreonama and 1 g nacubactam
imipenem/cilastatinDrug
1 g imipenem/1 g cilastatin
| Study group | Role | What they receive |
|---|---|---|
| co-administration of cefepime and nacubactam | Experimental | co-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion) Receives: Drug: co-administration of cefepime and nacubactam |
| co-administration of aztreonam and nacubactam | Experimental | co-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion) Receives: Drug: co-administration of aztreonam and nacubactam |
| imipenem/cilastatin | Active comparator | combination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion) Receives: Drug: imipenem/cilastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population
Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.
Measured: TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment]
Secondary outcomes (7)
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.
Assessment of clinical outcome was based on Investigator's evaluation of the patient's clinical signs and symptoms, with cure defined as the complete resolution (or return to premorbid state) of the baseline signs and symptoms of cUTI or AP that were present at screening, such that no further antimicrobial therapy is warranted.
Microbiological outcome was determined programmatically based on quantitative microbiological urine cultures, with eradication defined as the pathogen found at screening with 10^5 CFU/ml or more reduced to less than 10^3 CFU/ml.
The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.
Measured: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Clinical Outcome of Cure
Assessment of clinical outcome was based on Investigator's evaluation of the patient's clinical signs and symptoms, with cure defined as the complete resolution (or return to premorbid state) of the baseline signs and symptoms of cUTI or AP that were present at screening, such that no further antimicrobial therapy is warranted.
The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.
Measured: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Microbiological Outcome of Eradication
Microbiological outcome was determined programmatically based on quantitative microbiological urine cultures, with eradication defined as the pathogen found at screening with 10^5 CFU/ml or more reduced to less than 10^3 CFU/ml.
The results of subgroup analyses for only the two most frequent pathogens were shown because there were a large number of pathogen types, most of which were rare and sparsely represented in the dataset.
Measured: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline
Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia.
Assessment of clinical outcome was based on signs and symptoms, with cure defined as complete resolution or significant improvement of the baseline signs and symptoms of secondary bacteremia.
Measured: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline
Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia.
Microbiological outcome will be determined programmatically based on blood cultures, with eradication defined as the pathogen found at screening is negative in blood culture.
Measured: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients Who Are Free From the Definition of Secondary Bacteremia AND a Clinical Outcome of Cure AND a Microbiological Outcome of Eradication From cUTI or AP at TOC in Patients With Secondary Bacteremia at Baseline
Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia. For cUTI/AP,Assessment is done by the same way as "Proportion of patients who achieve composite clinical and microbiological outcome". For secondary bacteremia, assessment of clinical outcome was based on signs and symptoms, with cure defined as complete resolution or significant improvement of the baseline signs and symptoms of secondary bacteremia. Microbiological outcome will be determined programmatically based on blood cultures, with eradication defined as the pathogen found at screening is negative in blood culture.
Measured: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC
Patients with isolation of a gram-negative bacteria from at least 1 blood culture at baseline and this isolated pathogen is also identified from the site of infection and signs and symptoms of secondary bacteremia were determined programmatically as secondary bacteremia. Assessment of clinical outcome was based on signs and symptoms, with cure defined as complete resolution or significant improvement of the baseline signs and symptoms of secondary bacteremia. Microbiological outcome will be determined programmatically based on blood cultures, with eradication defined as the pathogen found at screening is negative in blood culture.
Measured: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start23 May 2023
- Primary completion22 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complicated Urinary Tract InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887908
- Sponsor's protocol ID
- OP0595-5
- Acronym
- Integral-1
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2023
- Last updated
- 24 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Takahashi S, Tateda K, Yanagihara K, Huang H, Doi Y, Yasuda M, Matsumoto K, Sumiya M, Takaya R, Suwada K, Kamiyabu S, Sasagawa Y, Minamida T, Kato S, Kondo K, Naruse T, Mikamo H. Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial. Lancet. 2026 May 16;407(10542):1929-1940. doi: 10.1016/S0140-6736(26)00596-9.
PubMed 42134354
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults
- ClinicalTrials.gov ID
- NCT05887908
- Acronym / sponsor ID
- Integral-1 / OP0595-5
- Conditions
- Complicated Urinary Tract Infection, Acute Pyelonephritis, cUTI, AP
- Keywords
- OP0595, nacubactam, Integral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| co-administration of cefepime and nacubactam | Experimental | Drug: co-administration of cefepime and nacubactamco-administration of 2 g cefepime and 1 g nacubactam q8h (60 min. infusion) |
| co-administration of aztreonam and nacubactam | Experimental | Drug: co-administration of aztreonam and nacubactamco-administration of 2 g aztreonam and 1 g nacubactam q8h (60 min. infusion) |
| imipenem/cilastatin | Active comparator | Drug: imipenem/cilastatincombination of 1 g imipenem/1 g cilastatin q8h (60 min. infusion) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients at least18 years of age (or age of legal consent, whichever is older) at the time of obtaining informed consent and who can be hospitalized throughout the Treatment Period;
- Weight at most 140 kg;
- Expectation, in the opinion of the Investigator, that the patient's cUTI or AP will require treatment with at least 5 days of IV antibiotics;
Key exclusion criteria (3 listed)
- Has a known imipenem- and/or meropenem-resistant Gram-negative uropathogen (at least 10^5 CFU/mL), isolated from study-qualifying urine culture; Note: If after randomization the susceptibility testing indicates resistance to imipenem and/or meropenem, the patient may remain on the study drug at the Investigator's discretion.
- Has known or suspected single or concurrent infection with Acinetobacter spp. or other organisms that are not adequately covered by the study drug (eg, concurrent viral, mycobacterial, or fungal infection) and needs to be managed with other anti-infectives; Note: Patients with qualifying pathogen coinfected with a Gram-positive pathogen may be administered narrow spectrum, open-label glycopeptide (eg, vancomycin), oxazolidinone (eg, linezolid), or daptomycin concomitantly with the study drug at the Investigator's discretion.
- Has only a known Gram-positive primary uropathogen (at least 10^5 CFU/mL), isolated from study qualifying urine culture;
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 |
|---|---|---|
| co-administration of cefepime and nacubactam2 g cefepime and 1 g nacubactam | Drug | co-administration of cefepime and nacubactam |
| co-administration of aztreonam and nacubactam2 g aztreonama and 1 g nacubactam | Drug | co-administration of aztreonam and nacubactam |
| imipenem/cilastatin1 g imipenem/1 g cilastatin | Drug | imipenem/cilastatin |
Primary outcome
Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population
Time frame: TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment]
Composite clinical and microbiological success is defined as the composite clinical outcome of cure and the microbiological outcome of eradication.
7 secondary outcomes
Proportion of Patients Who Achieve Composite Clinical and Microbiological Outcome
Time frame: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Clinical Outcome of Cure
Time frame: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Microbiological Outcome of Eradication
Time frame: Outcome measurements were assessed at various visits: EA (Earlly Assessment): Day4, EOT (End of Treatment): Day5 to Day14, TOC (Test of Cure visit): Day10 to Day 23, FUP (Follow-Up visit): Day17 to Day30
Proportion of Patients With a Clinical Outcome of Cure at TOC in Patients With Secondary Bacteremia at Baseline
Time frame: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients With a Microbiological Outcome of Eradication at TOC in Patients With Secondary Bacteremia at Baseline
Time frame: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients Who Are Free From the Definition of Secondary Bacteremia AND a Clinical Outcome of Cure AND a Microbiological Outcome of Eradication From cUTI or AP at TOC in Patients With Secondary Bacteremia at Baseline
Time frame: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Proportion of Patients Who Are Free From Secondary Bacteremia in Patients With Secondary Bacteremia at TOC
Time frame: TOC (Test of Cure visit): Day 10 to Day 23 after the start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42134354Takahashi S, Tateda K, Yanagihara K, Huang H, Doi Y, Yasuda M, Matsumoto K, Sumiya M, Takaya R, Suwada K, Kamiyabu S, Sasagawa Y, Minamida T, Kato S, Kondo K, Naruse T, Mikamo H. Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial. Lancet. 2026 May 16;407(10542):1929-1940. doi: 10.1016/S0140-6736(26)00596-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing co-administration of cefepime and nacubactam, co-administration of aztreonam and nacubactam and imipenem/cilastatin in people with Complicated Urinary Tract Infection and Acute Pyelonephritis, run by Meiji Seika Pharma Co., Ltd. at 61 sites in 9 countries.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Japan, China, Bulgaria, Czechia, Estonia and 4 more countries. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Who Achieve Composite Clinical and Microbiological Success at TOC (Test of Cure Visit) in the Microbiological Modified Intent-to-Treat (m-MITT) Population (time frame: TOC (Test of Cure visit): 7 [±2] days after EOT (end of treatment) [Day 10 to 23 after the start of treatment]). 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 NCT05887908, 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 24 Dec 2025.