Bacterial InfectionsPhase 3NCT02066402
Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate vs. Intravenous to Oral 10-Day Linezolid in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
A Phase 3 study testing Tedizolid (BAY119-2631) and Linezolid in people with Bacterial Infections, run by Bayer at 55 sites in 4 countries.
Trial summary
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Tedizolid (BAY119-2631) and Linezolid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 598 participants
- Where
- 55 sitesin 4 countries
- Study dates
- 4 Mar 2014to 18 Apr 2016
- Phase
- Phase 3
- 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
- Males or females >/=18 years old
- Adequate venous access for a minimum of 2 I.V. doses of study drug
- Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit
- Cellulitis/erysipelas
- Major cutaneous abscess
- Wound Infection
- Suspected or documented gram-positive infection from baseline Gram stain or culture.
Who cannot join
- Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
- Infections associated with, or in close proximity to, a prosthetic device
- Severe sepsis or septic shock
- Known bacteremia at time of screening
- ABSSSI due to or associated with any of the following:
- Suspected or documented gram-negative pathogens in patients with cellulitis/erysipelas or major cutaneous abscess that require an antibiotic with specific gram-negative coverage. Patients with wound infections where gram-negative adjunctive therapy is warranted may be enrolled if they meet the other eligibility criteria
Show all 18Show fewer
- Diabetic foot infections, gangrene, or perianal abscess
- Concomitant infection at another site not including a secondary ABSSSI lesion (eg, septic arthritis, endocarditis, osteomyelitis)
- Infected burns
- Decubitus or chronic skin ulcer, or ischemic ulcer due to peripheral vascular disease (arterial or venous)
- Any evolving necrotizing process (ie, necrotizing fasciitis)
- Use of antibiotics as follows:
- Systemic antibiotic with gram-positive cocci activity for the treatment of any infection within 24 hours before the first infusion of study drug
- Patients who failed prior therapy for the primary infection site are also excluded from enrollment
- Topical antibiotic on the primary lesion within 24 hours before the first infusion of study drug except for antibiotic/antiseptic-coated dressing applied to the clean postsurgical wound
- Administration of Linezolid within 30 days before the first infusion of the study drug
- Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome [AIDS])
- Previous exposure to Tedizolid Phosphate treatment
Trial locations and contacts
55 sites in 4 countries.
55 sites in 4 countries
China41 sites
Study site
Beijing, 100034
Study site
Beijing, 100044
Study site
Beijing, 100050
Study site
Beijing, 100191
Study site
Beijing, 100730
Study site
Changchun, Jilin, 130021
Study site
Changsha, Hunan, 410005
Study site
Changsha, Hunan, 410013
Study site
Changsha, Hunan, 410015
Study site
Chengdu, Sichuan, 610041
Study site
Chongqing, 400042
Study site
Dalian, Liaoning, 116027
Study site
Fuzhou, Fujian, 350025
Study site
Guangzhou, Guangdong, 510120
Study site
Guangzhou, Guangdong, 510180
Study site
Hangzhou, Zhejiang, 310003
Study site
Hangzhou, Zhejiang, 310009
Study site
Hangzhou, Zhejiang, 310014
Study site
Hangzhou, Zhejiang, 310016
Study site
Jinan, Shandong, 250012
Study site
Kunming, Yunnan, 650032
Study site
Nanjing, Jiangsu, 210029
Study site
Nanjing, Jiangsu
Study site
Shanghai, 200003
Study site
Shanghai, 200025
Study site
Shanghai, 200062
Study site
Shanghai, 200092
Study site
Shanghai, 201406
Study site
Shanghai, 201700
Study site
Shenyang, Liaoning, 110001
Study site
Shenyang, Liaoning, 110016
Study site
Suzhou, Jiangsu, 215006
Study site
Taiyuan, Shanxi, 030001
Study site
Tianjin, 300052
Study site
Tianjin, 300121
Study site
Ürümqi, Xinjiang, 830054
Study site
Wuhan, Hubei, 430030
Study site
Wuhu, Anhui, 241001
Study site
Wuxi, Jiangsu
Study site
Xi'an, Shaanxi, 710038
Study site
Xi'an, Shaanxi, 710061
Taiwan7 sites
Study site
Kaohsiung City, 807
Study site
Kaohsiung City, 81362
Study site
Taichung, 40447
Study site
Tainan, 710
Study site
Taipei, 10002
Study site
Taipei, 116
Study site
Taoyuan, 333
United States5 sites
Study site
Chula Vista, California, 91911
Study site
La Mesa, California, 91942
Study site
Las Vegas, Nevada, 89109
Study site
Oceanside, California, 92056
Study site
Teaneck, New Jersey, 07666
About this study
Official title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.
Read the detailed description
Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.
ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid
- Conditions
- Bacterial Infections
- Being tested
- Tedizolid (BAY119-2631), Placebo Tedizolid (BAY119-2631), Linezolid, Placebo Linezolid
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid (BAY119-2631)Drug
50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days
Placebo Tedizolid (BAY119-2631)Drug
50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days
LinezolidDrug
50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days
Placebo LinezolidDrug
50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days
| Study group | Role | What they receive |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Experimental | Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo. Receives: Drug: Tedizolid (BAY119-2631); Drug: Placebo Tedizolid (BAY119-2631); Drug: Placebo Linezolid |
| Linezolid | Active comparator | Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days. Receives: Drug: Placebo Tedizolid (BAY119-2631); Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
Measured: Baseline and 48-72 hours visit
Secondary outcomes (10)
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Clinical Failure: Presence of fever; No lesion size decrease from baseline; Clinician assessment of tenderness worse than mild; Persistent same or great intensity purulent drainage of wound infection; Confounding use of systemic concomitant antibiotic; TEAE lead to study drug discontinuation; Require additional antibiotic treatment for primary lesion; Unplanned major surgical intervention. Clinical Success: Afebrile or fever due to other cause; Lesion size decrease from baseline; Clinician assessment of mild/absent tenderness; None/lesser intensity purulent drainage of wound infection; None confounding use of systemic concomitant antibiotic; None TEAE leading to study drug discontinuation; No additional antibiotic therapy for primary lesion; No unplanned major surgical intervention; No osteomyelitis after baseline; For wound/abscess: no incision/drainage of the ABSSSI site after Day1 unless planned. For cellulitis/ersipelas: no incision/drainage of the ABSSSI site after 48-72 H Visit.
Measured: Baseline and EOT visit (Day 11)
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Clinical response will be defined as percentage of participants with clinical success, clinical failure or indeterminate.
Measured: Baseline and EOT visit (Day 11)
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Measured: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set
The Investigator made an assessment of clinical response at the PTE Visit (7-14 days after the EOT Visit +2 days). Participants assessed as a clinical failure at the EOT Visit are considered a clinical failure at the PTE Visit. Percentage of participants with clinical success, clinical failure or indeterminate were reported.
Measured: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Investigator's Assessment of Clinical Response at 48-72 Hours
The Investigator made an assessment of clinical response at the 48-72 Hour Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Stable (Signs and symptoms stable, no apparent change in overall clinical status but compatible with continuation of study drug therapy); Other.
Measured: Baseline and at 48-72 hours
Investigator's Assessment of Clinical Response at Day 7 Visit
The Investigator made an assessment of clinical response at Day 7 Visit based on following definition: Improving (Improvement in overall clinical status of ABSSSI compatible with continuation of study drug therapy); Other.
Measured: Baseline and Day 7 visit
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Measured: Up to EOT visit (Day 11)
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the visual analog scale (VAS) pain score. VAS pain score ranged from 0 mm (no pain) to 100 mm (worst pain ever). It used a 100 mm VAS to instruct the patient to indicate the point along the line that represents the pain they are feeling. Once the patient indicates how much pain they are feeling, measure the distance from no pain and enter the value.
Measured: Up to EOT visit (Day 11)
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Measured: Up to EOT visit (Day 11)
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. The patient-reported level of pain were assessed by the faces rating scale (FRS) pain score. Ask the patient to rate their pain from 0 to 10 with 0 being no pain at all and 10 being the worst pain then enter the numerical value.
Measured: Up to EOT visit (Day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study start4 Mar 2014
- Primary completion6 Mar 2016
- Study completion18 Apr 2016
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 Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by BayerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066402
- Sponsor's protocol ID
- 16121
- Status last verified
- May 2017
- First submitted
- 17 Feb 2014
- Last updated
- 7 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lv X, Alder J, Li L, O'Riordan W, Rybak MJ, Ye H, Zhang R, Zhang Z, Zhu X, Wilcox MH. Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection. Antimicrob Agents Chemother. 2019 Jun 24;63(7):e02252-18. doi: 10.1128/AAC.02252-18. Print 2019 Jul.
PubMed 30988146
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day Tedizolid Phosphate and Intravenous to Oral 10-Day Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
- ClinicalTrials.gov ID
- NCT02066402
- Acronym / sponsor ID
- 16121
- Conditions
- Bacterial Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Mar 2014 (actual)
- Primary completion
- 6 Mar 2016 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 7 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is aimed to evaluate the efficacy and safety between Tedizolid 200mg daily (intra venous) I.V. to oral for 6-day treatment compared with that of Linezolid 600mg twice daily I.V. to oral for 10-day treatment Acute Bacterial Skin and skin structure infection (ABSSSI).This is a double-blind, randomized, active control, 7-10days treatment for all subjects.
Detailed description
Number of participants with adverse evnets as a measure of safety and tolerability will be covered in Adverse Events section.
ABSSSI Efficacy Safety Tedizolid Phosphate Linezolid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tedizolid Phosphate (Sivextro, BAY119-2631) | Experimental | Drug: Tedizolid (BAY119-2631), Drug: Placebo Tedizolid (BAY119-2631), Drug: Placebo LinezolidParticipants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo. |
| Linezolid | Active comparator | Drug: Placebo Tedizolid (BAY119-2631), Drug: LinezolidParticipants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females >/=18 years old
- Adequate venous access for a minimum of 2 I.V. doses of study drug
- Acute Bacterial Skin and skin structure infection (ABSSSI) meeting at least 1 of the clinical syndrome definitions listed below and requiring I.V. antibiotic therapy. Local symptoms must have started within 7 days before the Screening Visit
- Suspected or documented gram-positive infection from baseline Gram stain or culture.
Key exclusion criteria (18 listed)
- Uncomplicated skin and skin structure infections such as furuncles, minor abscesses
- Infections associated with, or in close proximity to, a prosthetic device
- Severe sepsis or septic shock
- Known bacteremia at time of screening
- ABSSSI due to or associated with any of the following:
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 |
|---|---|---|
| Tedizolid (BAY119-2631)50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days | Drug | Tedizolid Phosphate (Sivextro, BAY119-2631) |
| Placebo Tedizolid (BAY119-2631)50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days | Drug | Linezolid, Tedizolid Phosphate (Sivextro, BAY119-2631) |
| Linezolid50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days | Drug | Linezolid |
| Placebo Linezolid50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days | Drug | Tedizolid Phosphate (Sivextro, BAY119-2631) |
Primary outcome
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set.
Time frame: Baseline and 48-72 hours visit
Early clinical response is defined as responder if there is >=20% reduction in the area of erythema, edema, and/or induration (length × width) of the primary acute bacterial skin and skin structure infections (ABSSSI) lesion, compared with baseline at the 48-72 Hour visit.
10 secondary outcomes
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the ITT Analysis Set
Time frame: Baseline and EOT visit (Day 11)
Programmatically Defined Clinical Response at End of Therapy (EOT) Visit in the Clinically Evaluable at EOT (CE-EOT) Analysis Set
Time frame: Baseline and EOT visit (Day 11)
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the ITT Analysis Set
Time frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Overall Investigator's Assessment of Clinical Success at Post Therapy Evaluation (PTE) Visit (7-14 Days After EOT Visit) in the Clinically Evaluable at Post Therapy Evaluation (CE-PTE) Analysis Set
Time frame: Baseline and post-therapy evaluation visit (7-14 days after Day 11)
Investigator's Assessment of Clinical Response at 48-72 Hours
Time frame: Baseline and at 48-72 hours
Investigator's Assessment of Clinical Response at Day 7 Visit
Time frame: Baseline and Day 7 visit
Value of the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Time frame: Up to EOT visit (Day 11)
Change From Baseline in the Visual Analog Scale (VAS) Pain Scores at Each Time Point
Time frame: Up to EOT visit (Day 11)
Value of the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Time frame: Up to EOT visit (Day 11)
Change From Baseline in the Faces Rating Scale (FRS) Pain Scores at Each Time Point
Time frame: Up to EOT visit (Day 11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30988146Lv X, Alder J, Li L, O'Riordan W, Rybak MJ, Ye H, Zhang R, Zhang Z, Zhu X, Wilcox MH. Efficacy and Safety of Tedizolid Phosphate versus Linezolid in a Randomized Phase 3 Trial in Patients with Acute Bacterial Skin and Skin Structure Infection. Antimicrob Agents Chemother. 2019 Jun 24;63(7):e02252-18. doi: 10.1128/AAC.02252-18. Print 2019 Jul.
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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.
Bayer Study Director study director
Bayer
55 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tedizolid (BAY119-2631) and Linezolid in people with Bacterial Infections, run by Bayer at 55 sites in 4 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 7 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in China, Taiwan, United States, Philippines. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Jun 2017). 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?
Percentage of Participants With Early Clinical Response at 48-72 Hours After the First Infusion of Study Drug in the ITT Analysis Set. (time frame: Baseline and 48-72 hours visit). 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 NCT02066402, 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 7 Jun 2017.