VRE InfectionAEGONNCT04624464
Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of VRE
An observational study of VRE Infection and Antibiotic Resistant Infection, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
The AEGON study is a German multicenter, prospective observational study. The study consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- VRE Infection, Antibiotic Resistant Infection
- What is being tested?
- Rectal swabs - microbiological analysis and Examination of patient room
- How many people
- 170 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Dec 2020
- How long will I take part?
- 10 Weeks
- 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: The selection of patients to be included in Part 1 of the AEGON study is based on the risk stratification for the nosocomial acquisition of VREf performed in the CONTROL study. It is planned to include a total of 150 patients from the participating study centers in Part 1. Based on the results of the CONTROL study, it can be assumed that within the selected target group in approx. 11% there is already an VREf colonisation by direct culture at admission and in 15% of the cases (22 of 150 patients) a nosocomial acquisition of VREf by direct culture (see method part) can be determined. Patients with VREcolonization detected at admission are excluded from the study.
Who may be able to join
- ≥ 18 years
- Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
- High risk of exposure to antibiotics during the stay
- Written informed consent of the patient after clarification has been given
Who cannot join
- Already known current or documented past colonisation or infection by VRE
- Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50931
Jörg Janne Vehreschild, MD, joerg.vehreschild@uk-koeln.de
About this study
Official title: Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of Vancomycin-resistant Enterococcus Faecium (VREf) - A Prospective Study
The AEGON study is a German multicenter, prospective observational study. The study consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VREf-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board (Antimicrobial Stewardship Board). In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure.
Read the detailed description
Current studies show that Vancomycin-resistant Enterococci (VRE) have become increasingly widespread throughout Germany in recent years, especially E. faecium (VREf). Healthy individuals can come into contact with VREf in various ways, for example via the food chain, contaminated drinking water or animal contacts. A possibly caused low-grade colonisation of the gastrointestinal tract with VREf (so-called low-level colonisation) can remain undetected during hospital admission using routine screening methods. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
The study is a German multicenter, prospective observational study and consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VRE-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board. In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
- Conditions
- VRE Infection, Antibiotic Resistant Infection
- Being tested
- Rectal swabs - microbiological analysis, Examination of patient room
- Keywords
- VRE, Infection Control Measures, Antimicrobial Stewardship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal swabs - microbiological analysisOther
Microbial analyses will be performed from the rectal swabs obtained.
Examination of patient roomOther
Only performed for cohort 2
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: VRE negative at admission | 150 patients meeting the following inclusion criteria:
* ≥ 18 years
* Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
* High risk of exposure to antibiotics during the stay
* Written informed consent of the patient after clarification has been given
Exclusion criteria:
* Already known current or documented past colonisation or infection by VRE
* Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use). Receives: Other: Rectal swabs - microbiological analysis | |
| Cohort 2: VRE positive at admission | A total 20 known VREf-positive patients meeting the following inclusion criteria:
* Intestinal VREf colonization already known at the time of admission (e.g. based on examinations during previous stays or in external facilities)
* Accommodation in a single room or alternatively multi-bed room with single occupancy on standard wards
* Expected stay of at least 7 days Receives: Other: Rectal swabs - microbiological analysis; Other: Examination of patient room |
What is being measured
The primary outcome is the main question the study is designed to answer.
VREf - Intestinal microbiota
Primary Outcome for Cohort 1: Rate of VREf intestinal colonization detected by enrichment culture or specific PCR at time of uptake not detected by standard culture methods
Measured: Baseline
VREf - Patient rooms
Primary Outcome for Cohort 2: Description of the spread of VREf in single rooms newly enrolled in known VREf-positive patients
Measured: Change from baseline spread to spread at 10 weeks.
Secondary outcomes (10)
Standard culture VREf detection
Cohort 1: Quantitative detection limit of standard culture methods for VREf detection compared to enrichment culture and qPCR (quantitative polymerase chain reaction)
Measured: baseline and every week up to 10 weeks max.
Antibiotics
Cohort 1: Identification of antibiotic classes that increase the risk of clonal expansion and subsequent domination by VREf. Domination by VREf is defined as the combination of cultural VREf detection from a sample and 16S rRNA (16S ribosomal ribonucleic acid) sequencing of the relative frequency of the Enterococcus genus over 30% as the most abundant genus in the sample.
Measured: baseline and every week up to 10 weeks max.
Inadequately administered antibiotics
Cohort 1: Proportion of inadequately administered antibiotics, defined as unnecessary, too long, too broad or too high doses in patients who develop VREf domination (see definition above) compared to patients without VREf acquisition and patients with VREf acquisition but without domination.
Measured: baseline and every week up to 10 weeks max.
Adequate antibiotic
Cohort 1: Rate of patients with no or adequate antibiotic therapy compared to patients with inadequate antibiotic therapy who develop a new colonization with VREf during the stay
Measured: baseline and every week up to 10 weeks max.
Influence of antibiotic exposure duration
Cohort 1: Influence of antibiotic exposure duration on microbiota
Measured: baseline and every week up to 10 weeks max.
Influence of antibiotic class
Cohort 1: Influence of antibiotic class on microbiota
Measured: baseline and every week up to 10 weeks max.
VREf contamination
Cohort 2: Identification of high risk objects and surfaces for VREf contamination in patient rooms with known VREf-positive patients
Measured: baseline at least every 72 hours up to max of 20 days.
Correlation of the antibiotic exposure
Cohort 2: Correlation of the antibiotic exposure of already known VREf-positive patients with the contamination load of objects and surfaces in the corresponding patient room.
Measured: baseline at least every 72 hours up to max of 20 days.
Contamination load of objects
Cohort 2: Correlation of the relative proportion of enterococci in intestinal microbiota with the contamination load of objects and surfaces in the associated patient room
Measured: baseline at least every 72 hours up to max of 20 days.
Cleaning quality
Cohort 2: Correlation of cleaning quality with the contamination load of VREf on objects and surfaces in rooms of known VRE-positive patients
Measured: baseline at least every 72 hours up to max of 20 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for VRE 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 10 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg, Universitätsklinikum Hamburg-Eppendorf, University Hospital Lübeck
- Responsible party
- Principal investigator, Dr. med. Jörg Janne Vehreschild, University Hospital of Cologne
- Investigators
- Jörg Janne Vehreschild, Prof. Dr. med, Principal investigator, University Hospital of CologneMaria J.G.T. Vehreschild, Prof. Dr. med, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624464
- Sponsor's protocol ID
- 19-1325
- Acronym
- AEGON
- Status last verified
- Nov 2020
- First submitted
- 30 Jul 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gastmeier P, Schroder C, Behnke M, Meyer E, Geffers C. Dramatic increase in vancomycin-resistant enterococci in Germany. J Antimicrob Chemother. 2014 Jun;69(6):1660-4. doi: 10.1093/jac/dku035. Epub 2014 Mar 9.
PubMed 24615816Liss BJ, Vehreschild JJ, Cornely OA, Hallek M, Fatkenheuer G, Wisplinghoff H, Seifert H, Vehreschild MJ. Intestinal colonisation and blood stream infections due to vancomycin-resistant enterococci (VRE) and extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBLE) in patients with haematological and oncological malignancies. Infection. 2012 Dec;40(6):613-9. doi: 10.1007/s15010-012-0269-y. Epub 2012 Jun 5.
PubMed 22665143Vehreschild MJGT, Haverkamp M, Biehl LM, Lemmen S, Fatkenheuer G. Vancomycin-resistant enterococci (VRE): a reason to isolate? Infection. 2019 Feb;47(1):7-11. doi: 10.1007/s15010-018-1202-9. Epub 2018 Sep 3.
PubMed 30178076Biehl LM, Higgins P, Wille T, Peter K, Hamprecht A, Peter S, Dorfel D, Vogel W, Hafner H, Lemmen S, Panse J, Rohde H, Klupp EM, Schafhausen P, Imirzalioglu C, Falgenhauer L, Salmanton-Garcia J, Stecher M, Vehreschild JJ, Seifert H, Vehreschild MJGT. Impact of single-room contact precautions on hospital-acquisition and transmission of multidrug-resistant Escherichia coli: a prospective multicentre cohort study in haematological and oncological wards. Clin Microbiol Infect. 2019 Aug;25(8):1013-1020. doi: 10.1016/j.cmi.2018.12.029. Epub 2019 Jan 12.
PubMed 30641228
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Antimicrobial Exposure and Infection Control Measures on the Spread of Vancomycin-resistant Enterococcus Faecium (VREf) - A Prospective Study
- ClinicalTrials.gov ID
- NCT04624464
- Acronym / sponsor ID
- AEGON / 19-1325
- Conditions
- VRE Infection, Antibiotic Resistant Infection
- Keywords
- VRE, Infection Control Measures, Antimicrobial Stewardship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Collaborators
- University of Freiburg, Universitätsklinikum Hamburg-Eppendorf, University Hospital Lübeck
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 Nov 2020 (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.
The AEGON study is a German multicenter, prospective observational study. The study consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VREf-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board (Antimicrobial Stewardship Board). In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure.
Detailed description
Current studies show that Vancomycin-resistant Enterococci (VRE) have become increasingly widespread throughout Germany in recent years, especially E. faecium (VREf). Healthy individuals can come into contact with VREf in various ways, for example via the food chain, contaminated drinking water or animal contacts. A possibly caused low-grade colonisation of the gastrointestinal tract with VREf (so-called low-level colonisation) can remain undetected during hospital admission using routine screening methods. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
The study is a German multicenter, prospective observational study and consists of two parts, which are carried out at all participating study sites and include two different patient cohorts. Part 1 focuses on the collection and analysis of rectal swabs from newly admitted VRE-negative patients at high risk of nosocomial VREf acquisition. Moreover, patients included into this part of the study will undergo in-depth documentation of clinical data if an antibiotic therapy is administered. Initiated antibiotic therapies will then be assessed by an AMS board. In Part 2, environmental investigations will be performed in newly occupied single rooms of previously known VREf-positive patients. In addition, rectal swabs will be collected and data on antibiotic exposure of these patients will be documented in order to correlate the VRE contamination burden of surfaces with the intestinal VREf-load and antibiotic exposure. The AEGON study, based on the use of state-of-the-art molecular diagnostics and comprehensive clinical data collection, will provide a detailed analysis of the factors involved in the rapid spread of VREf. In addition, diagnostic detection limits of common screening methods are determined by the use of additional diagnostics such as enrichment culture or molecular VREf detection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: VRE negative at admission | – | Other: Rectal swabs - microbiological analysis150 patients meeting the following inclusion criteria: * ≥ 18 years * Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days * High risk of exposure to antibiotics during the stay * Written informed consent of the patient after clarification has been given Exclusion criteria: * Already known current or documented past colonisation or infection by VRE * Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use). |
| Cohort 2: VRE positive at admission | – | Other: Rectal swabs - microbiological analysis, Other: Examination of patient roomA total 20 known VREf-positive patients meeting the following inclusion criteria: * Intestinal VREf colonization already known at the time of admission (e.g. based on examinations during previous stays or in external facilities) * Accommodation in a single room or alternatively multi-bed room with single occupancy on standard wards * Expected stay of at least 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The selection of patients to be included in Part 1 of the AEGON study is based on the risk stratification for the nosocomial acquisition of VREf performed in the CONTROL study. It is planned to include a total of 150 patients from the participating study centers in Part 1. Based on the results of the CONTROL study, it can be assumed that within the selected target group in approx. 11% there is already an VREf colonisation by direct culture at admission and in 15% of the cases (22 of 150 patients) a nosocomial acquisition of VREf by direct culture (see method part) can be determined. Patients with VREcolonization detected at admission are excluded from the study.
Key inclusion criteria (4 listed)
- ≥ 18 years
- Patients with malignant primary disease and current inpatient admission to a normal ward with expected inpatient stay of at least 15 days
- High risk of exposure to antibiotics during the stay
- Written informed consent of the patient after clarification has been given
Key exclusion criteria (2 listed)
- Already known current or documented past colonisation or infection by VRE
- Simultaneous participation in other studies is only an exclusion criterion if the other study explicitly excludes participation in observational studies or if the other study complicates the interpretation of the endpoints of AEGON (e.g. double-blind study on antibiotic use).
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 |
|---|---|---|
| Rectal swabs - microbiological analysisMicrobial analyses will be performed from the rectal swabs obtained. | Other | Cohort 1: VRE negative at admission, Cohort 2: VRE positive at admission |
| Examination of patient roomOnly performed for cohort 2 | Other | Cohort 2: VRE positive at admission |
Primary outcome
VREf - Intestinal microbiota
Time frame: Baseline
Primary Outcome for Cohort 1: Rate of VREf intestinal colonization detected by enrichment culture or specific PCR at time of uptake not detected by standard culture methods
VREf - Patient rooms
Time frame: Change from baseline spread to spread at 10 weeks.
Primary Outcome for Cohort 2: Description of the spread of VREf in single rooms newly enrolled in known VREf-positive patients
10 secondary outcomes
Standard culture VREf detection
Time frame: baseline and every week up to 10 weeks max.
Antibiotics
Time frame: baseline and every week up to 10 weeks max.
Inadequately administered antibiotics
Time frame: baseline and every week up to 10 weeks max.
Adequate antibiotic
Time frame: baseline and every week up to 10 weeks max.
Influence of antibiotic exposure duration
Time frame: baseline and every week up to 10 weeks max.
Influence of antibiotic class
Time frame: baseline and every week up to 10 weeks max.
VREf contamination
Time frame: baseline at least every 72 hours up to max of 20 days.
Correlation of the antibiotic exposure
Time frame: baseline at least every 72 hours up to max of 20 days.
Contamination load of objects
Time frame: baseline at least every 72 hours up to max of 20 days.
Cleaning quality
Time frame: baseline at least every 72 hours up to max of 20 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 24615816Gastmeier P, Schroder C, Behnke M, Meyer E, Geffers C. Dramatic increase in vancomycin-resistant enterococci in Germany. J Antimicrob Chemother. 2014 Jun;69(6):1660-4. doi: 10.1093/jac/dku035. Epub 2014 Mar 9.
- Background: PubMed 22665143Liss BJ, Vehreschild JJ, Cornely OA, Hallek M, Fatkenheuer G, Wisplinghoff H, Seifert H, Vehreschild MJ. Intestinal colonisation and blood stream infections due to vancomycin-resistant enterococci (VRE) and extended-spectrum beta-lactamase-producing Enterobacteriaceae (ESBLE) in patients with haematological and oncological malignancies. Infection. 2012 Dec;40(6):613-9. doi: 10.1007/s15010-012-0269-y. Epub 2012 Jun 5.
- Background: PubMed 30178076Vehreschild MJGT, Haverkamp M, Biehl LM, Lemmen S, Fatkenheuer G. Vancomycin-resistant enterococci (VRE): a reason to isolate? Infection. 2019 Feb;47(1):7-11. doi: 10.1007/s15010-018-1202-9. Epub 2018 Sep 3.
- Background: PubMed 30641228Biehl LM, Higgins P, Wille T, Peter K, Hamprecht A, Peter S, Dorfel D, Vogel W, Hafner H, Lemmen S, Panse J, Rohde H, Klupp EM, Schafhausen P, Imirzalioglu C, Falgenhauer L, Salmanton-Garcia J, Stecher M, Vehreschild JJ, Seifert H, Vehreschild MJGT. Impact of single-room contact precautions on hospital-acquisition and transmission of multidrug-resistant Escherichia coli: a prospective multicentre cohort study in haematological and oncological wards. Clin Microbiol Infect. 2019 Aug;25(8):1013-1020. doi: 10.1016/j.cmi.2018.12.029. Epub 2019 Jan 12.
- Individual participant dataSharing planned: Undecided
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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.
Jörg Janne Vehreschild, Prof. Dr. med principal investigator
University Hospital of Cologne
Maria J.G.T. Vehreschild, Prof. Dr. med principal investigator
University Hospital of Cologne
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 VRE Infection and Antibiotic Resistant Infection, run by University Hospital of Cologne at 1 site in Germany.
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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. 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 Germany. 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 Annika Y. Claßen, Dr. med (+49221 47897345, annika.classen@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VREf - Intestinal microbiota (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 NCT04624464, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.