Skin and Subcutaneous Tissue Bacterial InfectionsPhase 2NCT01283581

A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections

A Phase 2 study testing Delafloxacin, Linezolid and Vancomycin in people with Skin and Subcutaneous Tissue Bacterial Infections, run by Melinta Therapeutics, Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Skin and Subcutaneous Tissue Bacterial Infections
What is being tested?: Delafloxacin, Linezolid and Vancomycin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 31 sitesUnited States
Study dates: Jan 2011to Nov 2011
Phase: Phase 2
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

Adult (≥ 18 years of age) men or women
Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug
Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug
Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection
Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (> 5.0mg/L)
In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy

Who cannot join

A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives
Women who are pregnant or lactating
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response
Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
Minor abscesses, unless present with one of the ABSSSI types
Any infection expected to require other antimicrobial agents in addition to study drug

Show all 20Show fewer

Receipt of > 24 hours of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented: the subject received a single dose of a short-acting antibacterial drug 3 or more days before clinical trial enrollment for surgical prophylaxis or recently completed treatment with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI
Receipt of more than 1 dose of a potentially effective antibacterial agent for treatment of the ABSSSI under study prior to enrollment
Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment
Severely compromised immune systems
Subjects taking any medicinal product which inhibits monoamine oxidases A or B or within 2 weeks of Screening
Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading
Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions
Subjects with carcinoid syndrome and/or subjects taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone
Known history of liver disease
History of severe renal impairment
Life expectancy of < 3 months
Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study
Subjects previously randomized in this study or in who have received a dose of an investigational drug within 30 days of randomization
Subjects > 140 kg in body weight

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

United States31 sites

Medical Development Centers, LLC
Baton Rouge, Louisiana, 70810
Southbay Pharma Research
Buena Park, California, 90620
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
eStudySite
Chula Vista, California, 91911
University of Missouri Health Care
Columbia, Missouri, 65212
Southeast Regional Research Group
Columbus, Georgia, 31904
Remington-Davis, Inc.
Columbus, Ohio, 43215
Atlanta Institute for Medical Research, Inc
Decatur, Georgia, 30030
Riverside Clinical Research
Edgewater, Florida, 32132
Jennifer Johnson-Caldwell, MD
Houston, Texas, 77002
Alan Nolasco, MD
Houston, Texas, 77005
River City Clinical Research
Jacksonville, Florida, 32207
University of Kansas Medical Center
Kansas City, Kansas, 66160
Central Florida Internists
Kissimmee, Florida, 34741
eStudySite
La Mesa, California, 91942
eStudySite
Las Vegas, Nevada, 89109
Ravi Kamepalli, MD
Lima, Ohio, 45801
HealthCare Partners Medical Group
Los Angeles, California, 90015
University of South Alabama Medical Center
Mobile, Alabama, 36617
Drug Research and Analysis Corp
Montgomery, Alabama, 36106
Christiana Care Health Services
Newark, Delaware, 19713
eStudySite
Oceanside, California, 92056
Central Florida Internists Medical
Orlando, Florida, 32811
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003
HealthCare Partners Medical Group
Pasadena, California, 91105
Health Concepts
Rapid City, South Dakota, 57702
Central Florida Internists
Saint Cloud, Florida, 34769
Southeast Regional Research Group
Savannah, Georgia, 31406
South Jersey Infectious Disease
Somers Point, New Jersey, 08244
Ronald Barbour, MD
Temple Terrace, Florida, 33617
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid

Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Being tested: Delafloxacin, Linezolid, Vancomycin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelafloxacinDrug
Also called RX-3341
300mg IV every 12 hours for 5-14 days
LinezolidDrug
Also called Zyvox
600mg IV every 12 hours for 5-14 days
VancomycinDrug
Also called Vancocin
15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days

Study groups in NCT01283581
Study group	Role	What they receive
Delafloxacin	Experimental	300 mg IV (intravenous) every 12 hours for 5-14 days Receives: Drug: Delafloxacin
Vancomycin	Active comparator	15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas Receives: Drug: Vancomycin
Linezolid	Active comparator	600 mg IV every 12 hours for 5-14 days Receives: Drug: Linezolid

What is being measured

The primary outcome is the main question the study is designed to answer.

Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Measured: Follow-up (Day 14 ± 1)

Secondary outcomes (6)

Erythema Clinical Success
The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.
Measured: 48 - 72 hours
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug*h/mL).
Measured: Through Day 3 (± 1 day)
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate.
Measured: Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Measured: Follow-up (Day 14 ± 1)
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Measured: Follow-up (Day 14 ± 1)
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Measured: Follow-up (Day 14 ± 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2011Nov 2011

First posted26 Jan 2011 (estimated)
Study startJan 2011
Primary completionNov 2011
Study completionNov 2011

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 (4)Papers the sponsor has linked to this study.
Other trials for Skin and Subcutaneous Tissue Bacterial 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01283581
Sponsor's protocol ID: RX-3341-202
Status last verified: Sep 2019
First submitted: 24 Jan 2011
Last updated: 16 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Results of a Phase 2 Study of Delafloxacin (DLX) Compared to Vancomycin (VAN) and Linezolid (LNZ) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) J. Longcor 1 , S. Hopkins 1 , L. Lawrence 1 , S. Green 2 , P. Mehra 2 , P. Manos 2 , W. Sears 2 , W. O'Riordan 2 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 eStudySite, San Diego, CA 52nd ICAAC, San Francisco, CA 2012
Characterization and In Vitro Activity of Delafloxacin (DLX) Against Isolates from a Phase 2 Study of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) L. Lawrence 1 , S. Hopkins 1 , D. Sahm 2 , Jennifer Deane 2 , E. Burak 1 , J. Longcor 1 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 Eurofins Medinet, Chantilly, VA 52nd ICAAC, San Franciso, 2012
Pharmacokinetics (PK) of Delafloxacin (DLX), Vancomycin (VAN), and Linezolid (LNZ) in a Phase 2 Exploratory Study in Subjects with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) R. Hoover 1 , L. Lawrence 1 , J. Longcor 1 , J. Greenfield 2 1 Rib - X Pharmaceuticals, New Haven, CT; 2 PharmaNet/i3, The Woodlands, TX 52nd ICAAC, San Francisco, CA, 2012
Kingsley J, Mehra P, Lawrence LE, Henry E, Duffy E, Cammarata SK, Pullman J. A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016 Mar;71(3):821-9. doi: 10.1093/jac/dkv411. Epub 2015 Dec 17.
PubMed 26679243

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid
ClinicalTrials.gov ID: NCT01283581
Acronym / sponsor ID: RX-3341-202
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Melinta Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 26 Jan 2011 (estimated)
Results: Posted 29 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Delafloxacin	Experimental	Drug: Delafloxacin300 mg IV (intravenous) every 12 hours for 5-14 days
Vancomycin	Active comparator	Drug: Vancomycin15 mg/kg, up to 1250 mg, IV every 12 hours for 5-14 dyas
Linezolid	Active comparator	Drug: Linezolid600 mg IV every 12 hours for 5-14 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adult (≥ 18 years of age) men or women
Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug
Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug
Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection
Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (> 5.0mg/L)

Key exclusion criteria (20 listed)

A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives
Women who are pregnant or lactating
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response
Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis
Minor abscesses, unless present with one of the ABSSSI types

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
DelafloxacinAlso: RX-3341300mg IV every 12 hours for 5-14 days	Drug	Delafloxacin
LinezolidAlso: Zyvox600mg IV every 12 hours for 5-14 days	Drug	Linezolid
VancomycinAlso: Vancocin15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days	Drug	Vancomycin

Primary outcome

Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
Time frame: Follow-up (Day 14 ± 1)
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.

6 secondary outcomes

Erythema Clinical Success
Time frame: 48 - 72 hours
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
Time frame: Through Day 3 (± 1 day)
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
Time frame: Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Time frame: Follow-up (Day 14 ± 1)
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Time frame: Follow-up (Day 14 ± 1)
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
Time frame: Follow-up (Day 14 ± 1)

Results and safety

Results posted to the registry on 29 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delafloxacin IV (Intravenous)	81	69
Linezolid IV	77	63
Vancomycin IV	98	78

Primary outcome: Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up

Time frame: Follow-up (Day 14 ± 1). Number. Unit: Participants

Measure	Delafloxacin IV n = 81	Linezolid n = 77	Vancomycin n = 98
Value	57	50	53

Population analysed: ITT (intent-to-treat) population, defined as all subjects who were randomized.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delafloxacin IV	5 of 78 (6.4%)	59 of 78 (75.6%)	Not reported
Linezolid	2 of 75 (2.7%)	54 of 75 (72%)	Not reported
Vancomycin	6 of 96 (6.3%)	62 of 96 (64.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationResults of a Phase 2 Study of Delafloxacin (DLX) Compared to Vancomycin (VAN) and Linezolid (LNZ) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) J. Longcor 1 , S. Hopkins 1 , L. Lawrence 1 , S. Green 2 , P. Mehra 2 , P. Manos 2 , W. Sears 2 , W. O'Riordan 2 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 eStudySite, San Diego, CA 52nd ICAAC, San Francisco, CA 2012
Results publicationCharacterization and In Vitro Activity of Delafloxacin (DLX) Against Isolates from a Phase 2 Study of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) L. Lawrence 1 , S. Hopkins 1 , D. Sahm 2 , Jennifer Deane 2 , E. Burak 1 , J. Longcor 1 1 Rib - X Pharmaceuticals, Inc., New Haven, CT; 2 Eurofins Medinet, Chantilly, VA 52nd ICAAC, San Franciso, 2012
Results publicationPharmacokinetics (PK) of Delafloxacin (DLX), Vancomycin (VAN), and Linezolid (LNZ) in a Phase 2 Exploratory Study in Subjects with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) R. Hoover 1 , L. Lawrence 1 , J. Longcor 1 , J. Greenfield 2 1 Rib - X Pharmaceuticals, New Haven, CT; 2 PharmaNet/i3, The Woodlands, TX 52nd ICAAC, San Francisco, CA, 2012
Derived from this study: PubMed 26679243Kingsley J, Mehra P, Lawrence LE, Henry E, Duffy E, Cammarata SK, Pullman J. A randomized, double-blind, Phase 2 study to evaluate subjective and objective outcomes in patients with acute bacterial skin and skin structure infections treated with delafloxacin, linezolid or vancomycin. J Antimicrob Chemother. 2016 Mar;71(3):821-9. doi: 10.1093/jac/dkv411. Epub 2015 Dec 17.

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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.

Scott Hopkins, MD study director

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Delafloxacin, Linezolid and Vancomycin in people with Skin and Subcutaneous Tissue Bacterial Infections, run by Melinta Therapeutics, Inc. at 31 sites 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 6 inclusion and 20 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Oct 2013). 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?

Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up (time frame: Follow-up (Day 14 ± 1)). 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 NCT01283581, 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 16 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.