DysbiosisICMcNCT06095076
Cutaneous Microbiota Evolution in ICU Patients With CVC (ICMc)
An observational study of Dysbiosis and Catheter-Related Infections, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis, Catheter-Related Infections
- What is being tested?
- Skin swabbing and Data collection
- How many people
- 120 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 2 Jun 2023to 2 Jun 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated
Who may be able to join
- Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated
Who cannot join
- Patient under 18 years of age
- Patient or trusted person or family or relative objecting to participation in the study (refusal)
- Patient under judicial safeguard or under any other protective regime (guardianship or curatorship)
- Patient with cutaneous lesions (infection, burn) near the cutaneous insertion site of the CVC
Trial locations and contacts
1 site in 1 country.
French Guiana1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Cayenne
Cayenne, Guyane Française, 97306
Ariane ROUJANSKY, Dr, +594 594 39 53 54 ext. 53 54, ariane.roujansky@ch-cayenne.fr
Hatem KALLEL, PhD, hatem.kallel@ch-cayenne.fr
About this study
Official title: Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter (ICMc)
Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).
Read the detailed description
Central venous catheters (CVCs) are necessary in up to 60% of ICU patients, representing a risk of catheter-related infections with high morbidity and mortality. Catheter colonization originating mostly from the skin is constant, but infection is not. Dysbiosis is known to be associated with pathological states and infection, for example post-antibiotic C. difficile diarrheas, or atopic dermatitis, in which flares are associated with dysbiosis and S. aureus predominance. Cutanous dysbiosis could be the missing link between catheter colonization and infection. Our hypothesis is that under the influence of multiple ICU factors (stress, antibiotic administration, local dysinfection procedures), cutaneous dybiosis appears in ICU patients with a central venous catheter.
All adult ICU patients with an indication for CVC placement will be included over a 6 months period. Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed. General patient characteristics and informations relative to CVC infection and treatment will be collected.
This study will have no impact on patient management.
Category 3 Non-Interventional Human Person Research (RIPH 3)
- Conditions
- Dysbiosis, Catheter-Related Infections
- Being tested
- Skin swabbing, Data collection
- Keywords
- Microbiota, Cutaneous microbiota, Healthcare associated infection, Catheter-related infections
- Medical subject headings
- Dysbiosis, Catheter-Related Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin swabbingDiagnostic test
Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed.
Data collectionOther
General patient characteristics and informations relative to CVC infection and treatment will be collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of alpha-diversity
Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.
Measured: Baseline
Evolution of alpha-diversity
Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.
Measured: Day 3
Secondary outcomes (10)
Skin swabs Metagenomics
Metagenomics: Alpha and beta-diversity of skin swabs
Measured: Baseline
Skin colonization
Skin colonization: positive standard culture of skin swabs
Measured: Baseline
Catheter-related colonization
Catheter-related colonization: standard central line culture positivity
Measured: Baseline
Central Venous Catheter's Metagenomics
Metagenomics: alpha and beta-diversity of Central Venous Catheter at removal
Measured: Baseline
Catheter related Infection
Clinical signs and blood culture and/or positive catheter culture
Measured: Baseline
Skin swabs Metagenomics
Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.
Measured: Day 3
Skin colonization
Skin colonization: positive standard culture of skin swabs
Measured: Day 3
Catheter-related colonization
Catheter-related colonization: standard central line culture positivity
Measured: Day 3
Central Venous Catheter's Metagenomics
Metagenomics: alpha and beta-diversity of Central Venous Catheter at removal
Measured: Day 3
Catheter related Infection
Clinical signs and blood culture and/or positive catheter culture
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start2 Jun 2023
- Primary completion2 Dec 2023 (estimated)
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for DysbiosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
- Responsible party
- Sponsor
- Investigators
- Ariane ROUJANSKY, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095076
- Sponsor's protocol ID
- 2023_006
- Acronym
- ICMc
- Status last verified
- May 2023
- First submitted
- 20 Jun 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tacconelli E, Smith G, Hieke K, Lafuma A, Bastide P. Epidemiology, medical outcomes and costs of catheter-related bloodstream infections in intensive care units of four European countries: literature- and registry-based estimates. J Hosp Infect. 2009 Jun;72(2):97-103. doi: 10.1016/j.jhin.2008.12.012. Epub 2009 Feb 25.
PubMed 19246122Soufir L, Timsit JF, Mahe C, Carlet J, Regnier B, Chevret S. Attributable morbidity and mortality of catheter-related septicemia in critically ill patients: a matched, risk-adjusted, cohort study. Infect Control Hosp Epidemiol. 1999 Jun;20(6):396-401. doi: 10.1086/501639.
PubMed 10395140Christensen GD, Simpson WA, Bisno AL, Beachey EH. Adherence of slime-producing strains of Staphylococcus epidermidis to smooth surfaces. Infect Immun. 1982 Jul;37(1):318-26. doi: 10.1128/iai.37.1.318-326.1982.
PubMed 6179880Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.
PubMed 14647886Darouiche RO. Device-associated infections: a macroproblem that starts with microadherence. Clin Infect Dis. 2001 Nov 1;33(9):1567-72. doi: 10.1086/323130. Epub 2001 Sep 26.
PubMed 11577378Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
PubMed 8335977Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug 19;14(8):e1002533. doi: 10.1371/journal.pbio.1002533. eCollection 2016 Aug.
PubMed 27541692Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15.
PubMed 29332945Coates M, Lee MJ, Norton D, MacLeod AS. The Skin and Intestinal Microbiota and Their Specific Innate Immune Systems. Front Immunol. 2019 Dec 17;10:2950. doi: 10.3389/fimmu.2019.02950. eCollection 2019.
PubMed 31921196Nakatsuji T, Chen TH, Narala S, Chun KA, Two AM, Yun T, Shafiq F, Kotol PF, Bouslimani A, Melnik AV, Latif H, Kim JN, Lockhart A, Artis K, David G, Taylor P, Streib J, Dorrestein PC, Grier A, Gill SR, Zengler K, Hata TR, Leung DY, Gallo RL. Antimicrobials from human skin commensal bacteria protect against Staphylococcus aureus and are deficient in atopic dermatitis. Sci Transl Med. 2017 Feb 22;9(378):eaah4680. doi: 10.1126/scitranslmed.aah4680.
PubMed 28228596Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
PubMed 19478181Chen CH, Tu CC, Kuo HY, Zeng RF, Yu CS, Lu HH, Liou ML. Dynamic change of surface microbiota with different environmental cleaning methods between two wards in a hospital. Appl Microbiol Biotechnol. 2017 Jan;101(2):771-781. doi: 10.1007/s00253-016-7846-4. Epub 2016 Oct 22.
PubMed 27771740Chien AL, Tsai J, Leung S, Mongodin EF, Nelson AM, Kang S, Garza LA. Association of Systemic Antibiotic Treatment of Acne With Skin Microbiota Characteristics. JAMA Dermatol. 2019 Apr 1;155(4):425-434. doi: 10.1001/jamadermatol.2018.5221.
PubMed 30758497Seekatz AM, Young VB. Clostridium difficile and the microbiota. J Clin Invest. 2014 Oct;124(10):4182-9. doi: 10.1172/JCI72336. Epub 2014 Jul 18.
PubMed 25036699Kong HH, Oh J, Deming C, Conlan S, Grice EA, Beatson MA, Nomicos E, Polley EC, Komarow HD; NISC Comparative Sequence Program; Murray PR, Turner ML, Segre JA. Temporal shifts in the skin microbiome associated with disease flares and treatment in children with atopic dermatitis. Genome Res. 2012 May;22(5):850-9. doi: 10.1101/gr.131029.111. Epub 2012 Feb 6.
PubMed 22310478
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter (ICMc)
- ClinicalTrials.gov ID
- NCT06095076
- Acronym / sponsor ID
- ICMc / 2023_006
- Conditions
- Dysbiosis, Catheter-Related Infections
- Keywords
- Microbiota, Cutaneous microbiota, Healthcare associated infection, Catheter-related infections
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- Tropical Biome and ImmunoPhysiopathology (TBIP) - French Guiana University (Université de Guyane)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 2 Dec 2023 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 23 Oct 2023 (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.
Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).
Detailed description
Central venous catheters (CVCs) are necessary in up to 60% of ICU patients, representing a risk of catheter-related infections with high morbidity and mortality. Catheter colonization originating mostly from the skin is constant, but infection is not. Dysbiosis is known to be associated with pathological states and infection, for example post-antibiotic C. difficile diarrheas, or atopic dermatitis, in which flares are associated with dysbiosis and S. aureus predominance. Cutanous dysbiosis could be the missing link between catheter colonization and infection. Our hypothesis is that under the influence of multiple ICU factors (stress, antibiotic administration, local dysinfection procedures), cutaneous dybiosis appears in ICU patients with a central venous catheter.
All adult ICU patients with an indication for CVC placement will be included over a 6 months period. Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed. General patient characteristics and informations relative to CVC infection and treatment will be collected.
This study will have no impact on patient management.
Category 3 Non-Interventional Human Person Research (RIPH 3)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated
Key inclusion criteria (1 listed)
- Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated
Key exclusion criteria (4 listed)
- Patient under 18 years of age
- Patient or trusted person or family or relative objecting to participation in the study (refusal)
- Patient under judicial safeguard or under any other protective regime (guardianship or curatorship)
- Patient with cutaneous lesions (infection, burn) near the cutaneous insertion site of the CVC
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 |
|---|---|---|
| Skin swabbingSkin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed. | Diagnostic test | – |
| Data collectionGeneral patient characteristics and informations relative to CVC infection and treatment will be collected. | Other | – |
Primary outcome
Evolution of alpha-diversity
Time frame: Baseline
Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.
Evolution of alpha-diversity
Time frame: Day 3
Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.
10 secondary outcomes
Skin swabs Metagenomics
Time frame: Baseline
Skin colonization
Time frame: Baseline
Catheter-related colonization
Time frame: Baseline
Central Venous Catheter's Metagenomics
Time frame: Baseline
Catheter related Infection
Time frame: Baseline
Skin swabs Metagenomics
Time frame: Day 3
Skin colonization
Time frame: Day 3
Catheter-related colonization
Time frame: Day 3
Central Venous Catheter's Metagenomics
Time frame: Day 3
Catheter related Infection
Time frame: Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 19246122Tacconelli E, Smith G, Hieke K, Lafuma A, Bastide P. Epidemiology, medical outcomes and costs of catheter-related bloodstream infections in intensive care units of four European countries: literature- and registry-based estimates. J Hosp Infect. 2009 Jun;72(2):97-103. doi: 10.1016/j.jhin.2008.12.012. Epub 2009 Feb 25.
- Background: PubMed 10395140Soufir L, Timsit JF, Mahe C, Carlet J, Regnier B, Chevret S. Attributable morbidity and mortality of catheter-related septicemia in critically ill patients: a matched, risk-adjusted, cohort study. Infect Control Hosp Epidemiol. 1999 Jun;20(6):396-401. doi: 10.1086/501639.
- Background: PubMed 6179880Christensen GD, Simpson WA, Bisno AL, Beachey EH. Adherence of slime-producing strains of Staphylococcus epidermidis to smooth surfaces. Infect Immun. 1982 Jul;37(1):318-26. doi: 10.1128/iai.37.1.318-326.1982.
- Background: PubMed 14647886Safdar N, Maki DG. The pathogenesis of catheter-related bloodstream infection with noncuffed short-term central venous catheters. Intensive Care Med. 2004 Jan;30(1):62-7. doi: 10.1007/s00134-003-2045-z. Epub 2003 Nov 26.
- Background: PubMed 11577378Darouiche RO. Device-associated infections: a macroproblem that starts with microadherence. Clin Infect Dis. 2001 Nov 1;33(9):1567-72. doi: 10.1086/323130. Epub 2001 Sep 26.
- Background: PubMed 8335977Raad I, Costerton W, Sabharwal U, Sacilowski M, Anaissie E, Bodey GP. Ultrastructural analysis of indwelling vascular catheters: a quantitative relationship between luminal colonization and duration of placement. J Infect Dis. 1993 Aug;168(2):400-7. doi: 10.1093/infdis/168.2.400.
- Background: PubMed 27541692Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug 19;14(8):e1002533. doi: 10.1371/journal.pbio.1002533. eCollection 2016 Aug.
- Background: PubMed 29332945Byrd AL, Belkaid Y, Segre JA. The human skin microbiome. Nat Rev Microbiol. 2018 Mar;16(3):143-155. doi: 10.1038/nrmicro.2017.157. Epub 2018 Jan 15.
- Background: PubMed 31921196Coates M, Lee MJ, Norton D, MacLeod AS. The Skin and Intestinal Microbiota and Their Specific Innate Immune Systems. Front Immunol. 2019 Dec 17;10:2950. doi: 10.3389/fimmu.2019.02950. eCollection 2019.
- Background: PubMed 28228596Nakatsuji T, Chen TH, Narala S, Chun KA, Two AM, Yun T, Shafiq F, Kotol PF, Bouslimani A, Melnik AV, Latif H, Kim JN, Lockhart A, Artis K, David G, Taylor P, Streib J, Dorrestein PC, Grier A, Gill SR, Zengler K, Hata TR, Leung DY, Gallo RL. Antimicrobials from human skin commensal bacteria protect against Staphylococcus aureus and are deficient in atopic dermatitis. Sci Transl Med. 2017 Feb 22;9(378):eaah4680. doi: 10.1126/scitranslmed.aah4680.
- Background: PubMed 19478181Grice EA, Kong HH, Conlan S, Deming CB, Davis J, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Murray PR, Green ED, Turner ML, Segre JA. Topographical and temporal diversity of the human skin microbiome. Science. 2009 May 29;324(5931):1190-2. doi: 10.1126/science.1171700.
- Background: PubMed 27771740Chen CH, Tu CC, Kuo HY, Zeng RF, Yu CS, Lu HH, Liou ML. Dynamic change of surface microbiota with different environmental cleaning methods between two wards in a hospital. Appl Microbiol Biotechnol. 2017 Jan;101(2):771-781. doi: 10.1007/s00253-016-7846-4. Epub 2016 Oct 22.
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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.
Ariane ROUJANSKY principal investigator
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysbiosis and Catheter-Related Infections, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 1 inclusion and 4 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 23 Oct 2023. 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 French Guiana. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane ROUJANSKY (+594594395354, ariane.roujansky@ch-cayenne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of alpha-diversity (time frame: Baseline). 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 NCT06095076, which also lists 29 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 23 Oct 2023; AzTrials last refreshed its copy on 26 Oct 2026.