Urinary Tract InfectionsPhase 4NCT04197739
Fixed-dose Amikacin for Elderly UTI
A Phase 4 study testing Amikacin in people with Urinary Tract Infections and Elderly Infection, run by Rabin Medical Center.
Trial summary
Aminoglycosides are broad-spectrum antibiotics, effective against gram-negative bacteria. Aminoglycosides urine concentration exceeds that of the plasma by up to a hundred. Their efficacy is dependent on their level above minimal inhibitory concentration (MIC); however high levels are associate with nephrotoxicity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Urinary Tract Infections, Elderly Infection
- What is being tested?
- Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2021
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- A clinical diagnosis of UTI according to: pyuria, along with a new complaint of dysuria, urgency or frequency of urination, or lower abdominal pain or discomfort; AND one of the following: systemic fever, flank pain, tenderness over the costo-vertebral angle, rigors and chills, vomiting.
- Patients with moderate to severe cognitive impairment, who are unable to give reliable anamnesis, or those with permanent indwelling urinary catheter for 24 hours or more, will be considered as suffering from UTI is they present with systemic fever, pyuria and the lack of a more probable infectious cause.
- Patients who can give informed consent or those with a legal guardian who can consent on their behalf.
- Patients who received a single dose of any antimicrobial drug prior to recruitment, including amikacin.
- -
Who cannot join
- Creatinine clearance < 40 mL/sec according to the Cockcroft-Gault equation
- A known sensitivity to aminoglycosides
- A known neuromuscular pathology (including myasthenia gravis).
- Polycystic kidney disease
- A urine or blood culture positive for amikacin resistant bacteria in the 30 days prior to recruitment.
- Clinical suspicion of prostatitis, epididymitis or orchitis.
Show all 10Show fewer
- Hemodynamical instability (mean arterial pressure of 65 mmHg or under).
- More than one dose of antimicrobial treatment that is adequate for classical UTI bacteria, unless a bacterial culture shows resistance to said treatment.
- Immunosuppressed patients; steroidal treatment will be allowed.
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Fixed-low-dose Amikacin for Urinary Tract Infection on the Elderly Patient
Aminoglycosides are broad-spectrum antibiotics, effective against gram-negative bacteria. Aminoglycosides urine concentration exceeds that of the plasma by up to a hundred. Their efficacy is dependent on their level above minimal inhibitory concentration (MIC); however high levels are associate with nephrotoxicity. Therefore aminoglycosides have a narrow therapeutic rang. The correlation between administrated dose and blood drug levels is hard to predict. Amikacin is a highly effective aminoglycoside, highly effective against extended spectrum beta lactamase (ESBL) bacteria.
Older patients suffer from more urinary tract infection (UTIs), and have a higher frequency of infection with resistant bacteria, mainly among frail nursing home residents.
Read more
Our goal is to prove that fixed low dose amikacin in the elderly patient in non-inferior to weight-adjusted treatment.
Study design:
A randomized prospective, open label, non-inferiority trial
Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI will be assigned to one of the following study arms:
- Intervention arm: in which patients will receive a fixed dose of amikacin, 500 mg, once a day.
- Comparator arm: in which patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according plasma concentrations, using the Barnes Jewish Hospital nomogram.
All participants will be followed up with:
- Amikacin blood levels 6-14 hours following first administration, used for dose adjustment according to the nomogram. Peak amikacin blood levels, 30- 60 minutes following first or second administration.
- Urine analysis and culture upon admission to the emergency department (ER). In patients with indwelling urinary catheters, cultures will be taken following replacement with a new catheter.
- Broad serum biochemistry, complete blood count, C-reactive protein and blood cultures will be taken upon admission to the ER, two days after recruitment and at least once every three days following that, as long as the patient is receiving amikacin.
Duration of amikacin treatment will be according to the attending physician's clinical judgment; however, it will not be shorter than 72 hours since first dose. Total duration of amikacin treatment will not exceed 10 days. Total treatment for UTI will not fall short of seven days of antibiotics (either amikacin or any suitable alterative according to blood and/or urine cultures).
Read the detailed description
Study protocol: Safety and efficacy of fixed-low-dose amikacin for urinary tract infection on the elderly patient.
Aminoglycosides are broad-spectrum, bactericidal antibiotics, effective against gram-negative bacteria. Of this group, gentamicin and amikacin are frequently used in our center (Rabin Medical Center, Beilinson campus). Amikacin, a semi-synthetic aminoglycoside, is highly effective against extended spectrum beta lactamase (ESBL) bacteria, and is the most effective against aminoglycoside modifying enzymes resistance.
Aminoglycosides are water soluble and mainly eliminated through the kidney. Their urine concentration exceeds that of the plasma up to a hundred. Aminoglycosides have a narrow therapeutic range, and the correlation between administrated dose and blood drug levels is hard to predict. Aminoglycosides' efficacy is dependent on their level above minimal inhibitory concentration (MIC). Common clinical practice regarding amikacin today is to administer a weight adjusted first dose, later measuring the blood drug level and adjusting following doses according to a nomogram (such as the Barnes Jewish Hospital nomogram). The evidence base behind the usage of the nomogram is lacking at best.
Our main concern with aminoglycosides is nephrotoxicity; amikacin was found to be less nephrotoxic than gentamycin. The nephrotoxic effect is dependent on the cumulative dose, and is documented mainly in association with high doses and long treatment courses.
On the one hand, elderly patients suffer from more urinary tract infection (UTIs), and have a higher frequency of infection with resistant bacteria. This latter problem is on the rise especially among frail and elderly nursing home residents. On the other hand, elderly patients are more prone to nephrotoxicity from aminoglycosides, due to the age-related decrease in glomerular filtration rate (GFR), polypharmacy and comorbidities. There is a true and vast lack of clinical trials regarding amikacin use in elderly patients, especially those aged 75 years or older.
Our goal is to prove that fixed low dose amikacin in the elderly patient in non-inferior to weight-adjusted treatment.
The investigators hypothesize that the use of fixed dose, 500 mg of amikacin, in the elderly will cause less nephrotoxicity and less dose-adjusting, with no more clinical failures.
Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI.
Study design:
This is a prospective, open label, non-inferiority trial, in which consenting patients will be randomly assigned to one of the following study arms:
- Intervention arm: in which patients will receive a fixed, single daily dose of amikacin, 500 mg, a day.
- Comparator arm: in which patients will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram.
All participants will be followed up with:
- Amikacin blood levels 6-14 hours following first administration after recruitment, used for dose adjustment according to the nomogram. Peak amikacin blood levels, 30- 60 minutes following first or second administration.
- Urine analysis and urine culture upon admission to the emergency department (ER) (prior to recruitment). In patients with indwelling urinary catheters, cultures will be taken following replacement with a new catheter.
- Broad serum biochemistry, complete blood count, C-reactive protein and blood cultures will be taken upon admission to the ER, two days after recruitment and at least once every three days following that, as long as the patient is receiving amikacin.
If in the intervention arm, serum amikacin levels will be found to be higher than that recommended for single daily dose (meaning toxic levels), the dosing intervals will also be adjusted according to the Barnes Jewish Hospital nomogram.
Duration of amikacin treatment will be according to the attending physician's clinical judgment; however, it will not be shorter than 72 hours since first dose. Total duration of amikacin treatment will not exceed 10 days. Total treatment for UTI will not fall short of seven days of antibiotics (either amikacin or any suitable alterative according to blood and/or urine cultures).
In both study arms, dosage or time interval adjustments and antibiotic type changes will be done only in the presence of lacking clinical improvement or according to blood and/or urine cultures.
No. of patients to be recruited: 200. Ages: 65 years or older. Sex: male or female.
- Conditions
- Urinary Tract Infections, Elderly Infection
- Being tested
- Amikacin
- Keywords
- Urinary Tract Infections, Aminoglycosides, Amikacin, Elderly
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmikacinDrug
Patients in the intervention arm will receive a fixed, single daily dose of amikacin, 500 mg, a day.
Patients in the Comparator arm will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose | Experimental | patients will receive a fixed, single daily dose of amikacin, 500 mg, a day. Receives: Drug: Amikacin |
| Adjusted body weight dose | Active comparator | patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram. Receives: Drug: Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite clinical failure
A composite outcome of: clinical failure on day 5, all cause mortality on day 30, 30 days recurrent UTI.
Measured: 30 days
Secondary outcomes (5)
Rate of time-interval changes between amikacin doses
Incidence of time-interval changes between amikacin doses according to the Barnes Jewish Hospital nomogram.
Measured: 5 days
Rates of antimicrobial drug change
Rates of antimicrobial drug change due to any cause
Measured: 7-14 days
Clinical failure at day 5
Persistent fever after 72 hours of treatment
Measured: 5 days
Safety: acute kidney injury
Acute kidney injury according to the RIFLE criteria
Measured: 7-14 days
Vestibular toxicity
New complaints of dizziness or giddiness
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized prospective, open label, non-inferiority trial Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI will be assigned to one of the following study arms: 1. Intervention arm: in which patients will receive a fixed dose of amikacin, 500 mg, once a day. 2. Comparator arm: in which patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according plasma concentrations, using the Barnes Jewish Hospital nomogram.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197739
- Sponsor's protocol ID
- RMC-0619-19
- Status last verified
- Nov 2019
- First submitted
- 8 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fixed-low-dose Amikacin for Urinary Tract Infection on the Elderly Patient
- ClinicalTrials.gov ID
- NCT04197739
- Acronym / sponsor ID
- RMC-0619-19
- Conditions
- Urinary Tract Infections, Elderly Infection
- Keywords
- Urinary Tract Infections, Aminoglycosides, Amikacin, Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 13 Dec 2019 (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.
Aminoglycosides are broad-spectrum antibiotics, effective against gram-negative bacteria. Aminoglycosides urine concentration exceeds that of the plasma by up to a hundred. Their efficacy is dependent on their level above minimal inhibitory concentration (MIC); however high levels are associate with nephrotoxicity. Therefore aminoglycosides have a narrow therapeutic rang. The correlation between administrated dose and blood drug levels is hard to predict. Amikacin is a highly effective aminoglycoside, highly effective against extended spectrum beta lactamase (ESBL) bacteria.
Older patients suffer from more urinary tract infection (UTIs), and have a higher frequency of infection with resistant bacteria, mainly among frail nursing home residents.
Our goal is to prove that fixed low dose amikacin in the elderly patient in non-inferior to weight-adjusted treatment.
Study design:
A randomized prospective, open label, non-inferiority trial
Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI will be assigned to one of the following study arms:
- Intervention arm: in which patients will receive a fixed dose of amikacin, 500 mg, once a day.
- Comparator arm: in which patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according plasma concentrations, using the Barnes Jewish Hospital nomogram.
All participants will be followed up with:
- Amikacin blood levels 6-14 hours following first administration, used for dose adjustment according to the nomogram. Peak amikacin blood levels, 30- 60 minutes following first or second administration.
- Urine analysis and culture upon admission to the emergency department (ER). In patients with indwelling urinary catheters, cultures will be taken following replacement with a new catheter.
- Broad serum biochemistry, complete blood count, C-reactive protein and blood cultures will be taken upon admission to the ER, two days after recruitment and at least once every three days following that, as long as the patient is receiving amikacin.
Duration of amikacin treatment will be according to the attending physician's clinical judgment; however, it will not be shorter than 72 hours since first dose. Total duration of amikacin treatment will not exceed 10 days. Total treatment for UTI will not fall short of seven days of antibiotics (either amikacin or any suitable alterative according to blood and/or urine cultures).
Detailed description
Study protocol: Safety and efficacy of fixed-low-dose amikacin for urinary tract infection on the elderly patient.
Aminoglycosides are broad-spectrum, bactericidal antibiotics, effective against gram-negative bacteria. Of this group, gentamicin and amikacin are frequently used in our center (Rabin Medical Center, Beilinson campus). Amikacin, a semi-synthetic aminoglycoside, is highly effective against extended spectrum beta lactamase (ESBL) bacteria, and is the most effective against aminoglycoside modifying enzymes resistance.
Aminoglycosides are water soluble and mainly eliminated through the kidney. Their urine concentration exceeds that of the plasma up to a hundred. Aminoglycosides have a narrow therapeutic range, and the correlation between administrated dose and blood drug levels is hard to predict. Aminoglycosides' efficacy is dependent on their level above minimal inhibitory concentration (MIC). Common clinical practice regarding amikacin today is to administer a weight adjusted first dose, later measuring the blood drug level and adjusting following doses according to a nomogram (such as the Barnes Jewish Hospital nomogram). The evidence base behind the usage of the nomogram is lacking at best.
Our main concern with aminoglycosides is nephrotoxicity; amikacin was found to be less nephrotoxic than gentamycin. The nephrotoxic effect is dependent on the cumulative dose, and is documented mainly in association with high doses and long treatment courses.
On the one hand, elderly patients suffer from more urinary tract infection (UTIs), and have a higher frequency of infection with resistant bacteria. This latter problem is on the rise especially among frail and elderly nursing home residents. On the other hand, elderly patients are more prone to nephrotoxicity from aminoglycosides, due to the age-related decrease in glomerular filtration rate (GFR), polypharmacy and comorbidities. There is a true and vast lack of clinical trials regarding amikacin use in elderly patients, especially those aged 75 years or older.
Our goal is to prove that fixed low dose amikacin in the elderly patient in non-inferior to weight-adjusted treatment.
The investigators hypothesize that the use of fixed dose, 500 mg of amikacin, in the elderly will cause less nephrotoxicity and less dose-adjusting, with no more clinical failures.
Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI.
Study design:
This is a prospective, open label, non-inferiority trial, in which consenting patients will be randomly assigned to one of the following study arms:
- Intervention arm: in which patients will receive a fixed, single daily dose of amikacin, 500 mg, a day.
- Comparator arm: in which patients will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram.
All participants will be followed up with:
- Amikacin blood levels 6-14 hours following first administration after recruitment, used for dose adjustment according to the nomogram. Peak amikacin blood levels, 30- 60 minutes following first or second administration.
- Urine analysis and urine culture upon admission to the emergency department (ER) (prior to recruitment). In patients with indwelling urinary catheters, cultures will be taken following replacement with a new catheter.
- Broad serum biochemistry, complete blood count, C-reactive protein and blood cultures will be taken upon admission to the ER, two days after recruitment and at least once every three days following that, as long as the patient is receiving amikacin.
If in the intervention arm, serum amikacin levels will be found to be higher than that recommended for single daily dose (meaning toxic levels), the dosing intervals will also be adjusted according to the Barnes Jewish Hospital nomogram.
Duration of amikacin treatment will be according to the attending physician's clinical judgment; however, it will not be shorter than 72 hours since first dose. Total duration of amikacin treatment will not exceed 10 days. Total treatment for UTI will not fall short of seven days of antibiotics (either amikacin or any suitable alterative according to blood and/or urine cultures).
In both study arms, dosage or time interval adjustments and antibiotic type changes will be done only in the presence of lacking clinical improvement or according to blood and/or urine cultures.
No. of patients to be recruited: 200. Ages: 65 years or older. Sex: male or female.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized prospective, open label, non-inferiority trial Study participants will be 65 years or older, who were admitted to the medical ward due to a UTI will be assigned to one of the following study arms: 1. Intervention arm: in which patients will receive a fixed dose of amikacin, 500 mg, once a day. 2. Comparator arm: in which patients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according plasma concentrations, using the Barnes Jewish Hospital nomogram.
| Arm | Type | Receives |
|---|---|---|
| Fixed dose | Experimental | Drug: Amikacinpatients will receive a fixed, single daily dose of amikacin, 500 mg, a day. |
| Adjusted body weight dose | Active comparator | Drug: Amikacinpatients will receive a weight adjusted dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- A clinical diagnosis of UTI according to: pyuria, along with a new complaint of dysuria, urgency or frequency of urination, or lower abdominal pain or discomfort; AND one of the following: systemic fever, flank pain, tenderness over the costo-vertebral angle, rigors and chills, vomiting.
- Patients with moderate to severe cognitive impairment, who are unable to give reliable anamnesis, or those with permanent indwelling urinary catheter for 24 hours or more, will be considered as suffering from UTI is they present with systemic fever, pyuria and the lack of a more probable infectious cause.
- Patients who can give informed consent or those with a legal guardian who can consent on their behalf.
- Patients who received a single dose of any antimicrobial drug prior to recruitment, including amikacin.
- -
Key exclusion criteria (10 listed)
- Creatinine clearance < 40 mL/sec according to the Cockcroft-Gault equation
- A known sensitivity to aminoglycosides
- A known neuromuscular pathology (including myasthenia gravis).
- Polycystic kidney disease
- A urine or blood culture positive for amikacin resistant bacteria in the 30 days prior to recruitment.
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 |
|---|---|---|
| AmikacinPatients in the intervention arm will receive a fixed, single daily dose of amikacin, 500 mg, a day. Patients in the Comparator arm will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram | Drug | Adjusted body weight dose, Fixed dose |
Primary outcome
Composite clinical failure
Time frame: 30 days
A composite outcome of: clinical failure on day 5, all cause mortality on day 30, 30 days recurrent UTI.
5 secondary outcomes
Rate of time-interval changes between amikacin doses
Time frame: 5 days
Rates of antimicrobial drug change
Time frame: 7-14 days
Clinical failure at day 5
Time frame: 5 days
Safety: acute kidney injury
Time frame: 7-14 days
Vestibular toxicity
Time frame: 7-14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Related trials for Urinary Tract Infections
Active, not recruitingObservational study
Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR
Complicated Urinary Tract Infection
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amikacin in people with Urinary Tract Infections and Elderly Infection, run by Rabin Medical Center.
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 10 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yochai Levy, MD (+972502991516, YOCHAILE@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinical failure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2019.