Ventilator Associated PneumoniaPOS-VAPNCT05719259
Perpetual Observational Study - Ventilator Associated Pneumonia
An observational study of Ventilator Associated Pneumonia, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 35 sites in 13 countries.
Trial summary
Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator Associated Pneumonia
- How many people
- 20,000 participants
- Where
- 35 sitesin 13 countries
- Study dates
- 3 Aug 2022to 1 Mar 2027
- How long will I take part?
- 28 Days
- Phase
- Observational
- 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
Study population: All patients admitted to an ICU, who are under IMV and documented or expected to be under IMV for more than 48 hours are eligible to participate in the study
Who may be able to join
- Age≥18 years
- At risk of acquiring VAP during ICU stay, defined as:
- Requiring admission or being admitted to the ICU.
- Expected or documented to be under IMV for more than 48 hours.
- Consent, either a written informed consent given by the study patient in full medical, psychological, cognitive, social or legal capacity to give an informed consent, or, if not possible, by a Legally Authorized Representative of the study patient OR any applicable locally accepted form of consent OR consent waiver allowing data collection and sharing of data according to ECRAID's principles
Who cannot join
- Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
Trial locations and contacts
35 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
35 sites in 13 countries
France6 sites, 6 recruiting
- Recruiting
Centre Hospitalier William Morey
Chalon-sur-Saône, 71100
Claudine DESBROSSES, Claudine.Desbrosses@ch-chalon71.fr
Thomas MALDINEY, Dr
- Recruiting
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, 21079
Clotilde GRANGE, clotilde.grange@chu-dijon.fr
Jean Pierre QUENOT, Pr
- Recruiting
Centre Hospitalier de Le Mans
Le Mans, 72000
Marie Helene LEROYER, mhleroyer@ch-lemans.fr
Cedric DARREAU, Dr
- Recruiting
Centre Hospitalier Régional Universitaire de Lille
Lille, 59035
Amelie CERF, Amelie.CERF@chu-lille.fr
Saad NSEIR, Pr
- Recruiting
Centre Hospitalier Universitaire Dupuytren of Limoges
Limoges, 87000
Théo MERIGUET, Theo.MERIGUET@chu-limoges.fr
Thomas DAIX, Dr
- Recruiting
Centre Hospitalier Universitaire de Tours
Tours, 37000
Delphine CHARTIER, D.CHARTIER@chu-tours.fr
Denis GAROT, Dr
Belgium5 sites, 4 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc UCL
Brussels, 1200
Marie-France DUJARDIN, datanurse@saintluc.uclouvain.be
Jean-Baptiste MESLAND, Dr
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Daisy VERMEIREN, Daisy.Vermeiren@uzgent.be
Jan DE WAELE, Pr
- Recruiting
Hôpital de Jolimont
La Louvière, 7100
Anne-Catherine GERARD, Anne-Catherine.GERARD@jolimont.be
Isabelle BUELENS, Isabelle.Buelens@jolimont.be
- Not yet recruiting
Centre Hospitalier Universitaire de Liège
Liège, 4000
Axelle BERTRAND, axelle.bertrand@chuliege.be
LAMBERMONT Bernard, Pr
- Active, not recruiting
Clinique Saint Pierre Ottignies
Ottignies-Louvain-la-Neuve, 1340
Greece4 sites, 4 recruiting
- Not yet recruiting
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Vasileios PAPAIOANNOU, Pr, papabil69@gmail.com
Vasileios PAPAIOANNOU, Pr
- Not yet recruiting
Evangelismos General Hospital of Athens
Athens, 10676
Eirini DAIKOU, eirini.daikou@gmail.com
Maria THEODORAKOPOULOU, mariatheodor10@gmail.com
- Not yet recruiting
Sotiria Thoracic Diseases Hospital of Athens
Athens, 11527
Kostis PONTIKIS, Dr, kostis_pontikis@yahoo.gr
Antonia KOUTSOUKOU, Pr
- Not yet recruiting
General University Hospital of Larissa
Larissa, 41334
Demosthenes, dimomakris@uth.gr
appollon7@hotmail.com
Spain4 sites, 3 recruiting
- Active, not recruiting
Vall d'Hebrón University Hospital
Barcelona, 08035
- Recruiting
IMED Valencia
Burjassot, Valencia, 46100
Jose EXPOSITO OLLERO, jexposito@imedhospitales.com
Mercedes MURCIA ANAYA, Dr
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
Rafael LEON LOPEZ, Dr, RAFAEL.LEON.LOP@hotmail.com
Rafael LEON LOPEZ, Dr
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Lorena FORCELLEDO, Dr, lforcelledoespina@yahoo.es
Dolores ESCUDERO, Dr
Croatia3 sites, 3 recruiting
- Recruiting
Clinical Hospital Center Rijeka
Rijeka
Ivana ARAPOVIC, Ivana.Arapovic@kbc-rijeka.hr
Nataša SKOCIBUSIC, natasa.skocibusic@gmail.com
- Recruiting
General Hospital "Dr. Josip Benčević" Slavonski Brod
Slavonski Brod
Jasminka KOPIC, Jasminka.Kopic@bolnicasb.hr
Jasminka KOPIC, Dr
- Not yet recruiting
University Hospital for Infectious Diseases
Zagreb
Arjana TAMBIC, arjana.tambic@bfm.hr
ibutic@bfm.hr
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
John V Farman Intensive Care Unit
Cambridge
Andrew CONWAY MORRIS, Dr, ac926@cam.ac.uk
Andrew CONWAY MORRIS, Dr
- Not yet recruiting
Royal Infirmary of Edinburgh
Edinburgh, EH164SA
Thomas CRAVEN, Dr, Thomas.Craven@ed.ac.uk
Thomas CRAVEN, Dr
- Not yet recruiting
Royal Victoria Infirmary
Newcastle, NE14LP
Thomas HELLYER, Dr, Thomas.Hellyer@newcastle.ac.uk
Thomas HELLYER, Dr
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Kralovske Vinohrady
Brno-Vinohrady
Tereza CIBULKOVA, tereza.cibulkova@fnkv.cz
Nikola BANDIKOVA, nikola.bandikova@fnkv.cz
- Recruiting
University Hospital Motol
Prague
Eva ALJAMAL, Eva.Aljamal@fnmotol.cZ
Sarka SPECIANOVA, Sarka.Specianova@fnmotol.cz
Netherlands2 sites, 2 recruiting
- Recruiting
Deventer Ziekenhuis
Deventer, 7416
Arriette KRUISDIJK-GERRITSEN, A.Gerritsen@dz.nl
H VAN DEN OEVER, Dr
- Recruiting
University Medical Center Utrecht
Utrecht, 3584
Brittney VAN DER WOUDE, B.A.vanderWoude@umcutrecht.nl
Olaf CREMER, Pr
Romania2 sites, 2 recruiting
- Recruiting
Central Military Emergency University Hospital Dr. Carol Davila
Bucharest
Filomon RALUCA, filimon_raluca@yahoo.ro
Dan CORNECI, Pr
- Recruiting
Elias University Emergency Hospital
Bucharest
Oanamaria TUDORACHE, oanamaria.tudorache@yahoo.com
Silvius NEGOITA, Dr
Albania1 site, 1 recruiting
- Recruiting
University Hospital of Trauma
Tirana
Silva LEKA, Dr
Silva Leka, Dr.
Germany1 site, 1 recruiting
- Not yet recruiting
University Hospital Leipzig
Leipzig, 04103
Bastian PASIEKA, dR, bastian.pasieka@uni-leipzig.de
Sirak PETROS, Pr
Italy1 site, 1 recruiting
- Not yet recruiting
IRCCS Ospedale Policlinico Gemelli
Roma
Valentina DI GRAVIO, valentinadigravio@gmail.com
Gennaro DE PASCALE, Dr
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center of Serbia
Belgrade, 11000
Biljana CAREVIC, biljana.carevic@gmail.com
Ivana RADOVANOVIC, icaradovanovic@gmail.com
About this study
Official title: POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia
Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.
Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials.
The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.
Read the detailed description
Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).
Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).
RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.
These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.
Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator Associated Pneumonia, Hospital Acquired Infection, Mechanical Ventilation, Intensive Care Unit
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enrolled population | All patients meeting eligibility criteria (Adult patients, under a documented or expected time under mechanical ventilation of at least >48h) and providing one of: * Informed consent * Hospital level consent * Non-objection notice * Waiver of consent | |
| VAP population | Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up | |
| Microbiologically evaluable VAP population | Subset of the VAP population with a documented causative agent (bronchoalveolar lavage [BAL], endotracheal aspirate [ETA], blood sample, sputum, or pleural fluid) within 48 hours from VAP diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of research sites recruiting patients
POS-VAP' overarching objective is to build a sustainable European clinical research network of ICUs that serves as platform to facilitate observational and randomized VAP research activities.
This objective will be measured by in three ways:
- Total number of sites in the POS-VAP network that actively recruit patients
Measured: 4 years
Number of patients recruited in the study
- Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
Measured: 4 years
Number of studies implemented through the network
- Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
Measured: 4 years
Secondary outcomes (4)
Proportion of sites recruiting for an study implemented through the network
Average proportion of sites actively recruiting for at least one embedded study at any time during the study period, overall and stratified by observational and interventional embedded studies.
Measured: 4 years
Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network
Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.
Measured: 4 years
Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network
Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.
Measured: 4 years
Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network
Proportion (%) of POS-VAP VAP population enrolled in at least one embedded treatment study with clinical outcome after VAP as endpoint, stratified by observational and interventional embedded studies.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start3 Aug 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies 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
- 20,000 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)
- Sponsor type
- University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University Hospital, Limoges, UMC Utrecht
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719259
- Sponsor's protocol ID
- ECRAID-Base POS-VAP
- Acronym
- POS-VAP
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Individual data sharing
- Undecided: Data from this study will be used to inform future observational studies and RCTs about expected frequencies of exposures and clinical outcomes and expected recruitment rates for specific patient populations. Furthermore, the data will be used to support simulations to gain insight in the optimal design and required sample size of future RCTs as required for future embedded studies, which will be described in the appendices.
Publications
Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Bano J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. No abstract available.
PubMed 35940566
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia
- ClinicalTrials.gov ID
- NCT05719259
- Acronym / sponsor ID
- POS-VAP / ECRAID-Base POS-VAP
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- Ventilator Associated Pneumonia, Hospital Acquired Infection, Mechanical Ventilation, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- European Clinical Research Alliance for Infectious Diseases (ECRAID)University, hospital or other
- Collaborators
- University of Geneva, Switzerland, University Hospital, Limoges, UMC Utrecht
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Feb 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.
Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.
Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials.
The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.
Detailed description
Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).
Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).
RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.
These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.
Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enrolled population | – | –All patients meeting eligibility criteria (Adult patients, under a documented or expected time under mechanical ventilation of at least >48h) and providing one of: * Informed consent * Hospital level consent * Non-objection notice * Waiver of consent |
| VAP population | – | –Subset of the enrolled population fulfilling U.S. Food and Drug Administration (FDA) criteria for VAP diagnosis at any time during the follow up |
| Microbiologically evaluable VAP population | – | –Subset of the VAP population with a documented causative agent (bronchoalveolar lavage [BAL], endotracheal aspirate [ETA], blood sample, sputum, or pleural fluid) within 48 hours from VAP diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to an ICU, who are under IMV and documented or expected to be under IMV for more than 48 hours are eligible to participate in the study
Key inclusion criteria (5 listed)
- Age≥18 years
- At risk of acquiring VAP during ICU stay, defined as:
- Requiring admission or being admitted to the ICU.
- Expected or documented to be under IMV for more than 48 hours.
- Consent, either a written informed consent given by the study patient in full medical, psychological, cognitive, social or legal capacity to give an informed consent, or, if not possible, by a Legally Authorized Representative of the study patient OR any applicable locally accepted form of consent OR consent waiver allowing data collection and sharing of data according to ECRAID's principles
Key exclusion criteria (1 listed)
- Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of research sites recruiting patients
Time frame: 4 years
POS-VAP' overarching objective is to build a sustainable European clinical research network of ICUs that serves as platform to facilitate observational and randomized VAP research activities. This objective will be measured by in three ways: 1. Total number of sites in the POS-VAP network that actively recruit patients
Number of patients recruited in the study
Time frame: 4 years
2. Total number of patients in the POS-VAP network per analysis population (enrolled population, VAP population and microbiologically evaluable VAP population).
Number of studies implemented through the network
Time frame: 4 years
3. Total number of implemented observational studies and RCTs (stratified by domain: prevention, diagnosis and treatment).
4 secondary outcomes
Proportion of sites recruiting for an study implemented through the network
Time frame: 4 years
Proportion of patients enrolled through POS-VAP that are part of a preventive study implemented through the network
Time frame: 4 years
Proportion of patients enrolled through POS-VAP that are part of a diagnostic study implemented through the network
Time frame: 4 years
Proportion of VAP patients enrolled through POS-VAP that are part of a treatment study implemented through the network
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 35940566Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Bano J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. No abstract available.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data from this study will be used to inform future observational studies and RCTs about expected frequencies of exposures and clinical outcomes and expected recruitment rates for specific patient populations. Furthermore, the data will be used to support simulations to gain insight in the optimal design and required sample size of future RCTs as required for future embedded studies, which will be described in the appendices.
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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.
35 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia, run by European Clinical Research Alliance for Infectious Diseases (ECRAID) at 35 sites in 13 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in France, Belgium, Greece, Spain, Croatia and 8 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.
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 Bruno FRANCOIS, MD (+33 05 55 05 69 83, bruno.francois@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of research sites recruiting patients (time frame: 4 years). The study lists 3 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 NCT05719259, 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 10 Sep 2026.