Beta-lactam AntibioticsOPTIMAL TDMNCT03790631
The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring
An observational study of Beta-lactam Antibiotics and Therapeutic Drug Monitoring, run by University of Geneva, Switzerland at 1 site in Switzerland.
Trial summary
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin, ceftazidime and cefepime in patients at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta-lactam Antibiotics, Therapeutic Drug Monitoring, Toxicity
- What is being tested?
- The study is observational.
- How many people
- 771 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jan 2019to 31 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Included patients will be adults (≤18 years) hospitalized in the intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals and treated with one of the above-listed 7 beta-lactam antibiotics for a suspected or confirmed bacterial infections.
Who may be able to join
- Hospitalized patients with suspected or confirmed systemic bacterial infection:
- Receiving either imipenem-cilastatin, meropenem, amoxicillin (±clavulanic acid), flucloxacillin, piperacillin-tazobactam, ceftazidime or cefepime
- Aged ≥18 years
- Requiring intensive or intermediate-intensive (step-down) care OR severely immunosuppressed (see definitions)
Who cannot join
- Planned imminent transfer to an outside hospital
- Poor prognosis with life expectancy <1 week and/or intended transition to palliative care
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
About this study
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin, ceftazidime and cefepime in patients at increased risk of serious bacterial infections and currently understudied pharmacokinetics (the critically ill, the elderly, and the immunosuppressed).
This prospective observational study will include adult patients with suspected or confirmed systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals (HUG).
Read more
Eligible patients will be identified via the electronic health record (EHR). Patients receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours) after the therapy's start. Patients receiving continuous infusions will undergo TDM for at least one steady-state level. Clinical course will be observed for 30 days from the start of the study antibiotic (1st day of study antibiotic =day 1).
The primary outcome is incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
Read the detailed description
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin, ceftazidime and cefepime in patients at increased risk of serious bacterial infections and currently understudied pharmacokinetics (the critically ill, the elderly, and the immunosuppressed).
This prospective observational study will include adult patients with suspected or confirmed systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals (HUG).
Eligible patients will be identified via the electronic health record (EHR). Patients receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours) after the therapy's start. Patients receiving continuous infusions will undergo TDM for at least one steady-state level. Clinical course will be observed for 30 days from the start of the study antibiotic (1st day of study antibiotic =day 1).
The primary outcome is incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
- Conditions
- Beta-lactam Antibiotics, Therapeutic Drug Monitoring, Toxicity, Efficacy, Imipenem, Meropenem
- Being tested
- The study is observational.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study is observational.Other
The study is observational.
| Study group | Role | What they receive |
|---|---|---|
| imipenem TDM | Adult patients receiving imipenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| meropenem TDM | Adult patients receiving meropenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| piperacillin TDM | Adult patients receiving piperacillin (with or without tazobactam) for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| flucloxacillin TDM | Adult patients receiving flucloxacillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| amoxicillin TDM | Adult patients receiving amoxicillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| ceftazidime TDM | Adult patients receiving ceftazidime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. | |
| cefepime TDM | Adult patients receiving cefepime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. Receives: Other: The study is observational. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical toxicity through day 30 after start of study antibiotic
Incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration)
Measured: day 30 after start of antibiotic
Secondary outcomes (13)
Clinical response: incidence of clinical cure
Clinical response to therapy through day 30 will be measured study-wide. "Clinical response" is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection). Where the MIC is unavailable, EUCAST epidemiologic cutoffs (ECOFF) will be used; if no organism is isolated, non-species-related breakpoints for targeted organisms (e.g., Pseudomonas aeruginosa) will be used.
Measured: day 30
clinical response in patients with neutropenic fever: incidence of clinical cure in this subpopulation
Clinical response (as in outcome no. 2) in the subgroup of patients with neutropenic fever at the time of BL therapy. ("Clinical response" is either clinical cure (resolution of symptoms) or clinical failure (lack of improvement in signs and symptoms of infection OR recurrence of signs/symptoms of infection after initial improvement OR death in the 30-day study period considered at least possibly due to the infection).)
Measured: day 30
30-day mortality attributable to the treated infection
30-day mortality attributable to the treated infection
Measured: day 30
30-day all-cause mortality
30-day all-cause mortality
Measured: day 30
incidence of reversible toxicity
Proportion of adverse events (AE) that are reversible after discontinuation of the relevant BL antibiotic
Measured: day 30
Incidence of Clostridium difficile infection
Incidence of Clostridium difficile infection
Measured: day 30
Incidence of clinical toxicity of piperacillin-tazobactam when co-administered with vancomycin
Incidence of clinical toxicity of piperacillin-tazobactam (and other beta-lactam antibiotics) when co-administered with vancomycin
Measured: day 30
Incidence of emergence of resistance
Prevalence of emerging resistance to study antibiotics in clinical isolates (from baseline)
Measured: day 30
Incidence of undetectable beta-lactam plasma concentrations
Proportion of patients with undetectable beta-lactam trough and/or intermediate concentrations
Measured: day 30
Incidence of off-label prescribing
Proportion of patients for whom (a) beta-lactam dosing is "off-label" according to Swiss recommendations and (b) there are no dosing recommendations (e.g., hemofiltration)
Measured: day 30
The correlation of free versus total flucloxacillin concentrations
The correlation of free versus total flucloxacillin concentrations (in a subset of patients, free flucloxacillin plasma levels will also be measured and compared to those of total flucloxacillin).
Measured: day 30
Median intermediate and trough plasma concentrations of tazobactam
In a subset of patients receiving piperacillin/tazobactam, median intermediate and trough plasma concentrations of tazobactam (beta-lactamase inhibitor) in proportion to piperacillin in patients receiving piperacillin-tazobactam
Measured: through day 30
Beta-lactam trough concentration/minimal inhibitory concentration (MIC) index
The trough beta-lactam (BL) concentration/minimal inhibitory concentration (MIC) index on day 1 (±1) will be measured in all patients for later correlation analyses with clinical outcomes (clinical success versus failure).
Measured: day 1 (±1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start14 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Beta-lactam AntibioticsStudies 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
- 771 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Angela HUTTNER, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790631
- Sponsor's protocol ID
- 2018-01830
- Other IDs
- 2018
- Acronym
- OPTIMAL TDM
- Status last verified
- May 2025
- First submitted
- 27 Dec 2018
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be housed in a publicly accessible, non-profit digital repository such as Dryad or EUDAT.
Publications
Bricheux A, Lenggenhager L, Hughes S, Karmime A, Lescuyer P, Huttner A. Therapeutic drug monitoring of imipenem and the incidence of toxicity and failure in hospitalized patients: a retrospective cohort study. Clin Microbiol Infect. 2019 Mar;25(3):383.e1-383.e4. doi: 10.1016/j.cmi.2018.11.020. Epub 2018 Dec 4.
PubMed 30528370Huwyler T, Lenggenhager L, Abbas M, Ing Lorenzini K, Hughes S, Huttner B, Karmime A, Uckay I, von Dach E, Lescuyer P, Harbarth S, Huttner A. Cefepime plasma concentrations and clinical toxicity: a retrospective cohort study. Clin Microbiol Infect. 2017 Jul;23(7):454-459. doi: 10.1016/j.cmi.2017.01.005. Epub 2017 Jan 19.
PubMed 28111294Muller AE, Huttner B, Huttner A. Therapeutic Drug Monitoring of Beta-Lactams and Other Antibiotics in the Intensive Care Unit: Which Agents, Which Patients and Which Infections? Drugs. 2018 Mar;78(4):439-451. doi: 10.1007/s40265-018-0880-z.
PubMed 29476349Huttner A, Harbarth S, Hope WW, Lipman J, Roberts JA. Therapeutic drug monitoring of the beta-lactam antibiotics: what is the evidence and which patients should we be using it for? J Antimicrob Chemother. 2015 Dec;70(12):3178-83. doi: 10.1093/jac/dkv201. Epub 2015 Jul 17.
PubMed 26188037Marti C, Stirnemann J, Lescuyer P, Tonoli D, von Dach E; OPTIMAL TDM Study Group; Huttner A. Therapeutic drug monitoring and clinical outcomes in severely ill patients receiving amoxicillin: a single-centre prospective cohort study. Int J Antimicrob Agents. 2022 Jun;59(6):106601. doi: 10.1016/j.ijantimicag.2022.106601. Epub 2022 May 6.
PubMed 35533793
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPTIMAL TDM Study: Determining Optimal Beta-lactam Plasma Concentrations Through Therapeutic Drug Monitoring
- ClinicalTrials.gov ID
- NCT03790631
- Acronym / sponsor ID
- OPTIMAL TDM / 2018-01830
- Conditions
- Beta-lactam Antibiotics, Therapeutic Drug Monitoring, Toxicity, Efficacy, Imipenem, Meropenem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 771 participants (actual)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 31 Dec 2018 (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.
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin, ceftazidime and cefepime in patients at increased risk of serious bacterial infections and currently understudied pharmacokinetics (the critically ill, the elderly, and the immunosuppressed).
This prospective observational study will include adult patients with suspected or confirmed systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals (HUG).
Eligible patients will be identified via the electronic health record (EHR). Patients receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours) after the therapy's start. Patients receiving continuous infusions will undergo TDM for at least one steady-state level. Clinical course will be observed for 30 days from the start of the study antibiotic (1st day of study antibiotic =day 1).
The primary outcome is incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
Detailed description
Little is known of beta-lactam antibiotics' true therapeutic plasma concentration range. The aims of this study are to define evidence-based, safe and effective upper and lower limits of the plasma concentrations of imipenem, meropenem, amoxicillin, flucloxacillin, piperacillin, ceftazidime and cefepime in patients at increased risk of serious bacterial infections and currently understudied pharmacokinetics (the critically ill, the elderly, and the immunosuppressed).
This prospective observational study will include adult patients with suspected or confirmed systemic bacterial infection receiving one of the above-named antibiotics and hospitalized in intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals (HUG).
Eligible patients will be identified via the electronic health record (EHR). Patients receiving traditional intermittent dosing or prolonged infusions will undergo TDM for at least one intermediate (mid-interval) and one trough level at 24 hours (-12 or +48 hours) after the therapy's start. Patients receiving continuous infusions will undergo TDM for at least one steady-state level. Clinical course will be observed for 30 days from the start of the study antibiotic (1st day of study antibiotic =day 1).
The primary outcome is incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration). Secondary outcomes are listed below.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| imipenem TDM | – | Other: The study is observational.Adult patients receiving imipenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| meropenem TDM | – | Other: The study is observational.Adult patients receiving meropenem for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| piperacillin TDM | – | Other: The study is observational.Adult patients receiving piperacillin (with or without tazobactam) for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| flucloxacillin TDM | – | Other: The study is observational.Adult patients receiving flucloxacillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| amoxicillin TDM | – | Other: The study is observational.Adult patients receiving amoxicillin for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| ceftazidime TDM | – | Other: The study is observational.Adult patients receiving ceftazidime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
| cefepime TDM | – | Other: The study is observational.Adult patients receiving cefepime for suspected or confirmed bacterial infection. TDM will be performed to assess intermediate and trough levels once the patient is at steady-state. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Included patients will be adults (≤18 years) hospitalized in the intensive-care, step-down, or hematology-oncology units of the Geneva University Hospitals and treated with one of the above-listed 7 beta-lactam antibiotics for a suspected or confirmed bacterial infections.
Key inclusion criteria (4 listed)
- Hospitalized patients with suspected or confirmed systemic bacterial infection:
- Receiving either imipenem-cilastatin, meropenem, amoxicillin (±clavulanic acid), flucloxacillin, piperacillin-tazobactam, ceftazidime or cefepime
- Aged ≥18 years
- Requiring intensive or intermediate-intensive (step-down) care OR severely immunosuppressed (see definitions)
Key exclusion criteria (2 listed)
- Planned imminent transfer to an outside hospital
- Poor prognosis with life expectancy <1 week and/or intended transition to palliative care
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 |
|---|---|---|
| The study is observational.The study is observational. | Other | amoxicillin TDM, cefepime TDM, ceftazidime TDM, flucloxacillin TDM, imipenem TDM, meropenem TDM, piperacillin TDM |
Primary outcome
Incidence of clinical toxicity through day 30 after start of study antibiotic
Time frame: day 30 after start of antibiotic
Incidence of clinical toxicity through day 30 after start of study antibiotic (as stratified by BL trough concentration)
13 secondary outcomes
Clinical response: incidence of clinical cure
Time frame: day 30
clinical response in patients with neutropenic fever: incidence of clinical cure in this subpopulation
Time frame: day 30
30-day mortality attributable to the treated infection
Time frame: day 30
30-day all-cause mortality
Time frame: day 30
incidence of reversible toxicity
Time frame: day 30
Incidence of Clostridium difficile infection
Time frame: day 30
Incidence of clinical toxicity of piperacillin-tazobactam when co-administered with vancomycin
Time frame: day 30
Incidence of emergence of resistance
Time frame: day 30
Incidence of undetectable beta-lactam plasma concentrations
Time frame: day 30
Incidence of off-label prescribing
Time frame: day 30
The correlation of free versus total flucloxacillin concentrations
Time frame: day 30
Median intermediate and trough plasma concentrations of tazobactam
Time frame: through day 30
Beta-lactam trough concentration/minimal inhibitory concentration (MIC) index
Time frame: day 1 (±1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Results publication: PubMed 30528370Bricheux A, Lenggenhager L, Hughes S, Karmime A, Lescuyer P, Huttner A. Therapeutic drug monitoring of imipenem and the incidence of toxicity and failure in hospitalized patients: a retrospective cohort study. Clin Microbiol Infect. 2019 Mar;25(3):383.e1-383.e4. doi: 10.1016/j.cmi.2018.11.020. Epub 2018 Dec 4.
- Results publication: PubMed 28111294Huwyler T, Lenggenhager L, Abbas M, Ing Lorenzini K, Hughes S, Huttner B, Karmime A, Uckay I, von Dach E, Lescuyer P, Harbarth S, Huttner A. Cefepime plasma concentrations and clinical toxicity: a retrospective cohort study. Clin Microbiol Infect. 2017 Jul;23(7):454-459. doi: 10.1016/j.cmi.2017.01.005. Epub 2017 Jan 19.
- Results publication: PubMed 29476349Muller AE, Huttner B, Huttner A. Therapeutic Drug Monitoring of Beta-Lactams and Other Antibiotics in the Intensive Care Unit: Which Agents, Which Patients and Which Infections? Drugs. 2018 Mar;78(4):439-451. doi: 10.1007/s40265-018-0880-z.
- Results publication: PubMed 26188037Huttner A, Harbarth S, Hope WW, Lipman J, Roberts JA. Therapeutic drug monitoring of the beta-lactam antibiotics: what is the evidence and which patients should we be using it for? J Antimicrob Chemother. 2015 Dec;70(12):3178-83. doi: 10.1093/jac/dkv201. Epub 2015 Jul 17.
- Derived from this study: PubMed 35533793Marti C, Stirnemann J, Lescuyer P, Tonoli D, von Dach E; OPTIMAL TDM Study Group; Huttner A. Therapeutic drug monitoring and clinical outcomes in severely ill patients receiving amoxicillin: a single-centre prospective cohort study. Int J Antimicrob Agents. 2022 Jun;59(6):106601. doi: 10.1016/j.ijantimicag.2022.106601. Epub 2022 May 6.
- Individual participant dataSharing planned: Undecided. Data may be housed in a publicly accessible, non-profit digital repository such as Dryad or EUDAT.
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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.
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 Beta-lactam Antibiotics and Therapeutic Drug Monitoring, run by University of Geneva, Switzerland at 1 site in Switzerland.
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 4 inclusion and 2 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 20 May 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of clinical toxicity through day 30 after start of study antibiotic (time frame: day 30 after start of antibiotic). 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 NCT03790631, which also lists 5 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 20 May 2025.