Clostridium Difficile InfectionPhase 4NCT03388268
TOX NEG Trial: Clostridium Difficile Diagnosis and Treatment
A Phase 4 study testing Oral Vancomycin, Toxin enzyme immunoassay and Nuceleic acid amplification test in people with Clostridium Difficile Infection and Diarrhea, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection, Diarrhea
- What is being tested?
- Oral Vancomycin, Toxin enzyme immunoassay and Nuceleic acid amplification test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2017to 31 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stool submitted to the BJH microbiology laboratory for C. difficile testing that tests negative for C. difficile toxins (C. difficile Tox A/B II, Alere, Waltham, MA) as part of routine clinical care and positive by NAAT (Xpert C. difficile, Cepheid, Sunnyvale, CA)
- Clinically significant diarrhea (≥3 diarrheal bowel movements per day or ≥1 diarrheal bowel movement plus abdominal pain)
- ≥18 years of age.
Who cannot join
- The presence of a condition associated with persistent / prolonged / recurrent diarrhea, including, but not limited to:
- Upcoming chemotherapy
- Previous or upcoming bone marrow/hematopoietic stem cell transplant,
- Leukemia: new, not in remission, or receiving chemotherapy
- Inflammatory bowel disease
- Crohn's disease
Show all 18Show fewer
- Ulcerative colitis
- Microscopic colitis
- Previous total colectomy
- Previous partial colectomy without return to formed bowel movement or previous resection of colon
- Colostomy or ileostomy
- Unable to follow study procedures
- Not expected to survive until study follow-up is complete
- Allergy or intolerance to oral vancomycin
- A history of CDI in the past 3 months
- Alternate infectious etiology for diarrhea
- Receipt of CDI antibiotic treatment (excluding empiric treatment given while pending EIA results)
- Does not provide consent will exclude a patient from participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blinded, Randomized Controlled Trial of Oral Vancomycin Versus Placebo in Hospitalized Patients With Diarrhea and Stool toXin NEGative But Nucleic Acid Amplification Test Positive for Toxigenic Clostridium Difficile (TOX NEG Trial)
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Currently, healthcare facilities use a wide variety of tests and strategies for identifying patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI; while this treatment is standard of care at many facilities, the risk and benefits of treating these patients for CDI is unknown.
We propose to perform a double blinded, randomized controlled non-inferiority trial of antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and benefits of CDI treatment in this population.
Read the detailed description
Study Purpose:
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Background:
Clostridium difficile infection (CDI) is the most common cause of healthcare-associated diarrhea. There is no gold standard diagnostic test for (CDI). Commercially available assays detect C. difficile or its toxins in stool. Nucleic acid amplification tests (NAAT) are much more sensitive than toxin enzyme immunoassays (EIA). However, clinical correlation is needed to determine who has CDI. Most US clinical microbiology laboratories have adopted NAATs for C. difficile under the presumption the enhanced analytical sensitivity was beneficial. Although some patients with NAAT-positive/toxin-negative stool have CDI and a false-negative toxin EIA, subsequent studies indicate most patients with NAAT-positive / toxin-negative stool do not have CDI. Rather, they are asymptomatic C. difficile carriers who have diarrhea for other reasons. Most of these studies also have limitations and considerable controversy remains for whether NAATs or toxin EIAs should be used when CDI is suspected.
Treatment of asymptomatic C. difficile carriers is not beneficial, and may result in harm. At hospitals that utilize NAATs, most patients with NAAT-positive / toxin-negative stool receive treatment for CDI. The most common treatments for CDI, metronidazole and oral vancomycin, are highly disruptive of the intestinal microbiome. These antimicrobials create selective pressures that promote the acquisition and proliferation of antimicrobial resistance and multidrug resistant organisms (MDRO), including public health threats such as MDRO Enterobacteriaceae like carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum beta-lactamase (ESBL) producing organisms, vancomycin-resistant Enterococcus (VRE), and the latest emerging threat Candida auris. This leads to MDRO infections and MDRO spread to others. Paradoxically, unnecessary treatment for CDI may increase risk for CDI once treatment is stopped contributing to CDI-related adverse events and C. difficile spread to others. Unnecessary CDI treatment potentially harms both that patient and other people. Whether the benefit of treating patients with NAAT-positive/toxin-negative stool that are missed cases of CDI outweighs the risk of treating patients with NAAT-positive/toxin-negative stool that are asymptomatic C. difficile carriers remains unknown.
This study is a double-blinded randomized controlled trial of CDI treatment for patients with NAAT-positive / toxin-negative stool. Such a trial is necessary to understand the risk-benefit of treating these patients for CDI. Patients with NAAT-positive / toxin-negative stool who consent to participate will be randomized to 10 days of oral vancomycin or placebo. Stool and environmental specimens will be obtained at regular time points and interrogated with culturomic and metagenomic methods. Patients will be followed until eight weeks after discontinuation of study drug. These data and specimens will be used to determine the impact of oral vancomycin versus placebo on the microbiome, C. difficile and MDRO colonization, environmental contamination, duration of diarrhea, CDI-related adverse events, and death.
Specific aims and hypotheses:
Specific Aim 1: Determine if there are differences in microbiome disruption and acquisition / persistence of C. difficile and other MDRO carriage in stool among patients with NAAT-positive / toxin-negative stool who are randomized to a 10-day course of oral vancomycin versus placebo.
Hypotheses: Study participants who receive oral vancomycin will have greater disruption of the taxonomic and functional metabolic profiles of the fecal microbiome, increases in antimicrobial resistance genes, acquire more MDRO, and will have greater persistence and abundance of MDRO in stool compared to participants who receive placebo. Participants who receive oral vancomycin will not have detectable C. difficile in stool after completion of study drug, but will be more likely to have C. difficile in stool at week 8 after completion of study drug compared to participants who receive placebo.
Specific Aim 2: Determine if there are differences in C. difficile and other MDRO environmental contamination between treatment groups.
Hypothesis: Study participants who receive oral vancomycin will have less environmental C. difficile contamination but more MDRO contamination compared to participants who receive placebo while receiving study drug. After study drug is completed, those who receive oral vancomycin will have more environmental contamination due to both C. difficile and other MDROs.
Specific Aim 3: Determine if there are differences in CDI-related outcomes between groups.
Hypothesis: There will be no difference in time to resolution of diarrhea or CDI-related outcomes between treatment groups.
- Conditions
- Clostridium Difficile Infection, Diarrhea
- Being tested
- Oral Vancomycin, Placebo, Toxin enzyme immunoassay, Nuceleic acid amplification test
- Keywords
- Clostridium difficile, Diarrhea
- Medical subject headings
- Clostridium Infections, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral VancomycinDrug
Also called Vancocin
Oral vancomycin 125mg 4 times per day
PlaceboDrug
Sugar liquid manufactured to mimic oral vancomycin 125mg
Toxin enzyme immunoassayDevice
EIA assay: Wampole/Tech Lab Tox A/B II
Nuceleic acid amplification testDevice
NAAT: Xpert C. difficile, Cepheid
| Study group | Role | What they receive |
|---|---|---|
| Oral vancomycin | Active comparator | 125mg of oral vancomycin four times per day Receives: Drug: Oral Vancomycin; Device: Toxin enzyme immunoassay; Device: Nuceleic acid amplification test |
| Placebo | Placebo comparator | Placebo four times per day Receives: Drug: Placebo; Device: Toxin enzyme immunoassay; Device: Nuceleic acid amplification test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Detectable C. Difficile
Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Presence will be defined as presence of culturable C. difficile in stool any time after collection of enrollment stool samples.
Measured: Through 8 weeks after completion of study drug
Secondary outcomes (3)
Number of Participants With Detectable Environmental Contamination
Swabs from participants' home and hospital environments will be examined via culture and metagenomic analyses for the presence and/or persistence of C. difficile and other multidrug resistant organisms.
Measured: Through 8 weeks after completion of study drug
Duration of Diarrhea in Study Participants as Defined by Daily Symptoms and Questionnaire Using the Bristol Stool Chart
Duration of diarrhea will be compared between groups. Duration of diarrhea will be assessed daily during study drug using a questionnaire and the Bristol Stool Chart. The Bristol Stool Chart measures stool consistency. Diarrhea will be defined as Bristol Stool Chart types 5-7.
Measured: Through 8 weeks after completion of study drug
Presence of Other Multidrug Resistant Organisms in the Gut Microbiome of Study Participants
Stool specimens will be examined via culture and metagenomic analyses for the presence of multidrug resistant organisms before and after study drug.
Measured: Through 8 weeks after completion of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start29 Dec 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized controlled trial of CDI treatment with oral vancomycin vs. placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Dubberke, MD, MSPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388268
- Sponsor's protocol ID
- 201708055
- Status last verified
- Jul 2021
- First submitted
- 5 Dec 2017
- Last updated
- 26 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Publications
Fishbein SRS, Hink T, Reske KA, Cass C, Struttmann E, Iqbal ZH, Seiler S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Randomized Controlled Trial of Oral Vancomycin Treatment in Clostridioides difficile-Colonized Patients. mSphere. 2021 Jan 13;6(1):e00936-20. doi: 10.1128/mSphere.00936-20.
PubMed 33441409
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blinded, Randomized Controlled Trial of Oral Vancomycin Versus Placebo in Hospitalized Patients With Diarrhea and Stool toXin NEGative But Nucleic Acid Amplification Test Positive for Toxigenic Clostridium Difficile (TOX NEG Trial)
- ClinicalTrials.gov ID
- NCT03388268
- Acronym / sponsor ID
- 201708055
- Conditions
- Clostridium Difficile Infection, Diarrhea
- Keywords
- Clostridium difficile, Diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Currently, healthcare facilities use a wide variety of tests and strategies for identifying patients with CDI; both EIA and NAAT are widely used. There is no clear gold standard for identifying CDI. At WUSM and BJH, patients are only treated for CDI if they have a positive EIA. However, at many other healthcare facilities, the standard of care is to treat for CDI if the patient is NAAT positive. Some patients who are NAAT-positive may not have true CDI; while this treatment is standard of care at many facilities, the risk and benefits of treating these patients for CDI is unknown.
We propose to perform a double blinded, randomized controlled non-inferiority trial of antimicrobial of patients who are EIA negative, NAAT positive to determine the risks and benefits of CDI treatment in this population.
Detailed description
Study Purpose:
The purpose of this study is to determine the risks and benefits of antibiotic treatment for Clostridium difficile infection (CDI) among patients whose stool samples are nucleic acid amplification test (NAAT) positive and enzyme immunoassay (EIA) negative for C. difficile.
Background:
Clostridium difficile infection (CDI) is the most common cause of healthcare-associated diarrhea. There is no gold standard diagnostic test for (CDI). Commercially available assays detect C. difficile or its toxins in stool. Nucleic acid amplification tests (NAAT) are much more sensitive than toxin enzyme immunoassays (EIA). However, clinical correlation is needed to determine who has CDI. Most US clinical microbiology laboratories have adopted NAATs for C. difficile under the presumption the enhanced analytical sensitivity was beneficial. Although some patients with NAAT-positive/toxin-negative stool have CDI and a false-negative toxin EIA, subsequent studies indicate most patients with NAAT-positive / toxin-negative stool do not have CDI. Rather, they are asymptomatic C. difficile carriers who have diarrhea for other reasons. Most of these studies also have limitations and considerable controversy remains for whether NAATs or toxin EIAs should be used when CDI is suspected.
Treatment of asymptomatic C. difficile carriers is not beneficial, and may result in harm. At hospitals that utilize NAATs, most patients with NAAT-positive / toxin-negative stool receive treatment for CDI. The most common treatments for CDI, metronidazole and oral vancomycin, are highly disruptive of the intestinal microbiome. These antimicrobials create selective pressures that promote the acquisition and proliferation of antimicrobial resistance and multidrug resistant organisms (MDRO), including public health threats such as MDRO Enterobacteriaceae like carbapenem-resistant Enterobacteriaceae (CRE) and extended-spectrum beta-lactamase (ESBL) producing organisms, vancomycin-resistant Enterococcus (VRE), and the latest emerging threat Candida auris. This leads to MDRO infections and MDRO spread to others. Paradoxically, unnecessary treatment for CDI may increase risk for CDI once treatment is stopped contributing to CDI-related adverse events and C. difficile spread to others. Unnecessary CDI treatment potentially harms both that patient and other people. Whether the benefit of treating patients with NAAT-positive/toxin-negative stool that are missed cases of CDI outweighs the risk of treating patients with NAAT-positive/toxin-negative stool that are asymptomatic C. difficile carriers remains unknown.
This study is a double-blinded randomized controlled trial of CDI treatment for patients with NAAT-positive / toxin-negative stool. Such a trial is necessary to understand the risk-benefit of treating these patients for CDI. Patients with NAAT-positive / toxin-negative stool who consent to participate will be randomized to 10 days of oral vancomycin or placebo. Stool and environmental specimens will be obtained at regular time points and interrogated with culturomic and metagenomic methods. Patients will be followed until eight weeks after discontinuation of study drug. These data and specimens will be used to determine the impact of oral vancomycin versus placebo on the microbiome, C. difficile and MDRO colonization, environmental contamination, duration of diarrhea, CDI-related adverse events, and death.
Specific aims and hypotheses:
Specific Aim 1: Determine if there are differences in microbiome disruption and acquisition / persistence of C. difficile and other MDRO carriage in stool among patients with NAAT-positive / toxin-negative stool who are randomized to a 10-day course of oral vancomycin versus placebo.
Hypotheses: Study participants who receive oral vancomycin will have greater disruption of the taxonomic and functional metabolic profiles of the fecal microbiome, increases in antimicrobial resistance genes, acquire more MDRO, and will have greater persistence and abundance of MDRO in stool compared to participants who receive placebo. Participants who receive oral vancomycin will not have detectable C. difficile in stool after completion of study drug, but will be more likely to have C. difficile in stool at week 8 after completion of study drug compared to participants who receive placebo.
Specific Aim 2: Determine if there are differences in C. difficile and other MDRO environmental contamination between treatment groups.
Hypothesis: Study participants who receive oral vancomycin will have less environmental C. difficile contamination but more MDRO contamination compared to participants who receive placebo while receiving study drug. After study drug is completed, those who receive oral vancomycin will have more environmental contamination due to both C. difficile and other MDROs.
Specific Aim 3: Determine if there are differences in CDI-related outcomes between groups.
Hypothesis: There will be no difference in time to resolution of diarrhea or CDI-related outcomes between treatment groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial of CDI treatment with oral vancomycin vs. placebo
| Arm | Type | Receives |
|---|---|---|
| Oral vancomycin | Active comparator | Drug: Oral Vancomycin, Device: Toxin enzyme immunoassay, Device: Nuceleic acid amplification test125mg of oral vancomycin four times per day |
| Placebo | Placebo comparator | Drug: Placebo, Device: Toxin enzyme immunoassay, Device: Nuceleic acid amplification testPlacebo four times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stool submitted to the BJH microbiology laboratory for C. difficile testing that tests negative for C. difficile toxins (C. difficile Tox A/B II, Alere, Waltham, MA) as part of routine clinical care and positive by NAAT (Xpert C. difficile, Cepheid, Sunnyvale, CA)
- Clinically significant diarrhea (≥3 diarrheal bowel movements per day or ≥1 diarrheal bowel movement plus abdominal pain)
- ≥18 years of age.
Key exclusion criteria (18 listed)
- The presence of a condition associated with persistent / prolonged / recurrent diarrhea, including, but not limited to:
- Upcoming chemotherapy
- Previous or upcoming bone marrow/hematopoietic stem cell transplant,
- Leukemia: new, not in remission, or receiving chemotherapy
- Inflammatory bowel disease
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 |
|---|---|---|
| Oral VancomycinAlso: VancocinOral vancomycin 125mg 4 times per day | Drug | Oral vancomycin |
| PlaceboSugar liquid manufactured to mimic oral vancomycin 125mg | Drug | Placebo |
| Toxin enzyme immunoassayEIA assay: Wampole/Tech Lab Tox A/B II | Device | Oral vancomycin, Placebo |
| Nuceleic acid amplification testNAAT: Xpert C. difficile, Cepheid | Device | Oral vancomycin, Placebo |
Primary outcome
Number of Participants With Detectable C. Difficile
Time frame: Through 8 weeks after completion of study drug
Stool specimens will be examined via culture and metagenomic analyses for the presence of detectable C. difficile. Presence will be defined as presence of culturable C. difficile in stool any time after collection of enrollment stool samples.
3 secondary outcomes
Number of Participants With Detectable Environmental Contamination
Time frame: Through 8 weeks after completion of study drug
Duration of Diarrhea in Study Participants as Defined by Daily Symptoms and Questionnaire Using the Bristol Stool Chart
Time frame: Through 8 weeks after completion of study drug
Presence of Other Multidrug Resistant Organisms in the Gut Microbiome of Study Participants
Time frame: Through 8 weeks after completion of the study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33441409Fishbein SRS, Hink T, Reske KA, Cass C, Struttmann E, Iqbal ZH, Seiler S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Randomized Controlled Trial of Oral Vancomycin Treatment in Clostridioides difficile-Colonized Patients. mSphere. 2021 Jan 13;6(1):e00936-20. doi: 10.1128/mSphere.00936-20.
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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.
Erik Dubberke, MD, MSPH principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Vancomycin, Toxin enzyme immunoassay and Nuceleic acid amplification test in people with Clostridium Difficile Infection and Diarrhea, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 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 26 Jul 2021. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Detectable C. Difficile (time frame: Through 8 weeks after completion of study drug). 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 NCT03388268, 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 26 Jul 2021.