Skin and Subcutaneous Tissue Bacterial InfectionsPhase 3NCT01421511

TR-701 FA vs Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

A Phase 3 study testing TR-701 FA and Linezolid in people with Skin and Subcutaneous Tissue Bacterial Infections, run by Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 117 sites in 11 countries.

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

This is a randomized, double-blind, double-dummy, multicenter, global Phase 3 study of IV to oral TR-701 FA 200 mg once daily for 6 days versus IV to oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. 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?: TR-701 FA and Linezolid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 666 participants
Where: 117 sitesin 11 countries
Study dates: 15 Sep 2011to 10 Jan 2013
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

Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Who cannot join

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens

Trial locations and contacts

117 sites in 11 countries.

Country

City, postcode or hospital

117 sites in 11 countries

United States35 sites

Trius investigator site 150
Baton Rouge, Louisiana, 70809
Trius investigator site 154
Boston, Massachusetts, 02115
Trius investigator site 138
Carmel, Indiana, 46032
Trius investigator site 103
Chula Vista, California, 91911
Trius investigator site 101
Columbus, Georgia, 31904
Trius investigator site 140
Columbus, Ohio, 43215
Trius investigator site 164
Creve Coeur, Missouri, 63141
Trius investigator site 139
Denver, Colorado, 80218
Trius investigator site 159
Dothan, Alabama, 36305
Trius investigator site 166
Edgewater, Florida, 32132
Trius investigator site 143
Escondido, California, 92025
Trius investigator site 165
Eunice, Louisiana, 70535
Trius investigator site 155
Franklin, Tennessee, 37064
Trius investigator site 148
Houston, Texas, 77030
Trius investigator site 105
La Mesa, California, 91942
Trius investigator site 160
Las Vegas, Nevada, 89169
Trius investigator site 162
Lima, Ohio, 45801
Trius investigator site 106
Long Beach, California, 90813
Trius investigator site 157
Long Beach, California, 90813
Trius investigator site 145
Memphis, Tennessee, 38104
Trius investigator site 153
Minneapolis, Minnesota, 55415
Trius investigator site 142
National City, California, 91950
Trius investigator site 137
Newark, Delaware, 19718
Trius investigator site 144
Owensboro, Kentucky, 42303
Trius investigator site 149
Picayune, Mississippi, 39466
Trius investigator site 161
Rapid City, South Dakota, 57702
Trius investigator site 163
Royal Oak, Michigan, 48073
Trius investigator site 170
San Diego, California, 92123
Trius investigator site 167
Santa Ana, California, 92701
Trius investigator site 169
Smyrna, Tennessee, 37167
Trius investigator site 146
Springfield, Massachusetts, 01199
Trius investigator site 168
Stockton, California, 95204
Trius investigator site 141
Sylmar, California, 91342
Trius investigator site 147
Teaneck, New Jersey, 07666
Trius investigator site 136
West Roxbury, Massachusetts, 02132

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Brazil14 sites

Trius investigator site 362
Belo Horizonte, MG, Brazil, 30110-934
Trius investigator site 361
Belo Horizonte, MG, Brazil, 30140-062
Trius investigator site 361
Belo Horizonte
Trius investigator site 362
Belo Horizonte
Trius investigator site 365
Belo Horizonte
Trius investigator site 364
Campinas, SP, Brazil, 13060-904
Trius investigator site 364
Campinas
Trius investigator site 366
Curitiba
Trius investigator site 367
Curitiba
Trius investigator site 369
Jaú
Trius investigator site 363
Porto Alegre, RS, Brazil, 90110-270
Trius investigator site 363
Porto Alegre
Trius investigator site 370
Porto Alegre
Trius investigator site 360
São Paulo

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Russia14 sites

Trius investigator site 287
Barmaul, 656024
Trius investigator site 286
Irkutsk, 664079
Trius investigator site 293
Lipetsk, 389035/398005
Trius investigator site 295
Moscow, 115093
Trius investigator site 290
Moscow, 115280
Trius investigator site 291
Moscow, 115280
Trius investigator site 288
Moscow, 119435
Trius investigator site 297
Novosibirsk, 630008
Trius investigator site 285
Novosibirsk, 630051
Trius investigator site 294
Saint Petersburg, 194291
Trius investigator site 289
Saint Petersburg, 198099
Trius investigator site 296
Saint Petersburg
Trius investigator site 298
Tomsk, 634063
Trius investigator site 292
Vsevolozhsk, Leningradskaya Oblast', 188640

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Argentina12 sites

Trius investigator site 354
Buenos Aires
Trius investigator site 355
Buenos Aires
Trius investigator site 351
Cludad Autonoma de Buenos Aires, C1155AHD
Trius investigator site 352
Cludadela, Buenos Aires, B1702FWM
Trius investigator site 354
General Roriquez, Buenos Aires, B1748
Trius investigator site 350
La Plata, Buenos Aires, B1900AXI
Trius investigator site 350
La Plata, Buenos Aires
Trius investigator site 358
La Plata
Trius investigator site 353
Luján, Buenos Aires, B6700AOJ
Trius investigator site 357
Mar del Plata
Trius investigator site 359
Paraná, Entre Rios
Trius investigator site 356
Rosario

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South Africa12 sites

Trius investigator site 445
Benoni, 1501
Trius investigator site 442
Bloemfontein, Free States, 9317
Trius investigator site 441
Blowmfontein, Free States, 9301
Trius investigator 447
Breyten, Mpunalanga, 2330
Trius investigator 451
Centurion, Gauteng, 0157
Trius investigator 448
Dundee, KwaZulu-Natal, 3000
Trius investigator site 440
Gezina Pretoria, Gauteng, 0084
Trius investigator 446
Middelburg, Mpumalanga, 1051
Trius investigator 443
Port Elizabeth, Eastern Cape, 6020
Trius investigator 450
Pretoria, Gauteng, 0083
Trius investigator 449
Pretoria, Gauteng, 0084
Trius investigator 444
Worscester, Cape, 6850

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Australia7 sites

Trius investigator 500
Cairns, Queensland, 4870
Trius investigator 501
Herston, Queensland, 4029
Trius investigator 503
Nambour, Queensland, 4560
Trius investigator 505
Richmond, Victoria, 2131
Trius investigator 506
Southport, Queensland, 4215
Trius investigator 502
Woolloongabba, Queensland, 4102
Trius investigator 504
Woolloongabba, Queensland, 4102

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Poland6 sites

Trius investigator site 216
Bydgoszcz, 85-094
Trius investigator site 211
Lodz, 93-513
Trius investigator site 214
Lublin, 20-081
Trius investigator site 213
Poznan, 60-631
Trius investigator site 215
Szczecin, 70-111
Trius investigator site 212
Warsaw, 02-097

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Spain6 sites

Trius investigator site 272
Alcorcón, Madrid, 28922
Trius investigator site 277
Barakaldo, Vizcaya, 48903
Trius investigator site 276
Madrid, 28046
Trius investigator site 275
Majadahonda, Madrid, 28222
Trius investigator site 273
Mataró, Barcelona, 08304
Trius investigator site 274
Santander, 39008

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Germany5 sites

Trius investigator site 207
Berlin, 10249
Trius investigator site 208
Dresden, Saxony, 01307
Trius investigator site 205
Hamburg, 20246
Trius investigator site 204
Lübeck, Schleswig-Holstein, 23538
Trius investigator site 206
Quedlinburg, Saxony-Anhalt, 06484

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Mexico4 sites

Trius investigator site 380
Guadalajara
Trius investigator site 381
Guadalajara
Trius investigator site 382
Mexico City
Trius investigator site 383
Monterrey

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New Zealand2 sites

Trius investigator 521
Otahuhu, Auckland
Trius investigator 520
Sydenham, Christchurch, 8024

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About this study

Official title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI

Approximately 100 to 140 sites globally will participate in this study. Patients with an ABSSSI caused by suspected or documented gram positive pathogen(s) at baseline will be randomized 1:1 to study treatment.

Read the detailed description

The primary objective is to determine the noninferiority (NI) in the early clinical response rate of intravenous (IV) to oral 6 day TR-701 free acid (FA) compared with that of IV to oral 10-day linezolid treatment at 48-72 hours after the first infusion of study drug in the intent-to-treat (ITT) analysis set in patients with acute bacterial skin and skin structure infections (ABSSSI).

Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Being tested: TR-701 FA, Linezolid
Keywords: ABSSSI, Tedizolid Phosphate, TR-701, Acute Bacterial Skin and Skin Structure Infections

What participants receive

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

TR-701 FADrug
- TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
- TR-701 FA Tablets, 200 mg, orally once daily
LinezolidDrug
- Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
- Linezolid Tablets, 600 mg, orally every 12 hours

Study groups in NCT01421511
Study group	Role	What they receive
TR-701 FA	Experimental	• TR-701 FA IV followed by TR-701 FA tablets Receives: Drug: TR-701 FA
Linezolid	Active comparator	• Linezolid IV followed by Linezolid Tablets Receives: Drug: Linezolid

What is being measured

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

The Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline.
Measured: 48-72 hours

Secondary outcomes (7)

Clinical Response at the End of Therapy Visit
Responder: No increase in lesion surface area from baseline.
Measured: Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
Responder: No increase in lesion surface area from baseline.
Measured: End of Therapy Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
Measured: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.
Clinical success defined as resolution/near resolution of disease specific signs and symptoms, absence/near resolution of baseline systemic signs of infection, no new signs, symptoms or complications attributable to the ABSSSI and no further antibiotic therapy required for treatment of primary ABSSSI lesion.
Measured: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Clinical improvement defined as improvement in overall clinical status.
Measured: 48-72 Hours
Investigator's Assessment of Clinical Response at the Day-7 Visit
Clinical improvement defined as improvement in overall clinical status.
Measured: Day 7
Change From Baseline in Patient-reported Pain, by Study Visit
0=no pain, 10=worst pain Only 1 visit per participant for Day 4-6, only 1 visit for Day 7-9, and only 1 visit for Day 10-13.
Measured: Multiple

Timeline

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

15 Sep 201110 Jan 2013

First posted22 Aug 2011 (estimated)
Study start15 Sep 2011
Primary completion10 Jan 2013
Study completion10 Jan 2013

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 (6)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 666 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01421511
Sponsor's protocol ID: 1986-010
Other IDs: TR701-113
Status last verified: Jul 2018
First submitted: 19 Aug 2011
Last updated: 29 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Sandison T, De Anda C, Fang E, Das AF, Prokocimer P. Clinical Response of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections by Severity Measure Using a Pooled Analysis from Two Phase 3 Double-Blind Trials. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02687-16. doi: 10.1128/AAC.02687-16. Print 2017 May.
PubMed 28264845
Nathwani D, Corey R, Das AF, Sandison T, De Anda C, Prokocimer P. Early Clinical Response as a Predictor of Late Treatment Success in Patients With Acute Bacterial Skin and Skin Structure Infections: Retrospective Analysis of 2 Randomized Controlled Trials. Clin Infect Dis. 2017 Jan 15;64(2):214-217. doi: 10.1093/cid/ciw750. Epub 2016 Dec 21.
PubMed 28003218
Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
PubMed 27530088
Shorr AF, Lodise TP, Corey GR, De Anda C, Fang E, Das AF, Prokocimer P. Analysis of the phase 3 ESTABLISH trials of tedizolid versus linezolid in acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Feb;59(2):864-71. doi: 10.1128/AAC.03688-14. Epub 2014 Nov 24.
PubMed 25421472
Lodise TP, Fang E, Minassian SL, Prokocimer PG. Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials. Antimicrob Agents Chemother. 2014 Dec;58(12):7198-204. doi: 10.1128/AAC.03509-14. Epub 2014 Sep 22.
PubMed 25246392
Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014 Aug;14(8):696-705. doi: 10.1016/S1473-3099(14)70737-6. Epub 2014 Jun 5.
PubMed 24909499

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. 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 IV to Oral 6-Day TR-701 Free Acid and IV to Oral 10-Day Linezolid for the Treatment of ABSSSI
ClinicalTrials.gov ID: NCT01421511
Acronym / sponsor ID: 1986-010
Conditions: Skin and Subcutaneous Tissue Bacterial Infections
Keywords: ABSSSI, Tedizolid Phosphate, TR-701, Acute Bacterial Skin and Skin Structure Infections
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 666 participants (actual)
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 15 Sep 2011 (actual)
Primary completion: 10 Jan 2013 (actual)
Study completion: 10 Jan 2013 (actual)
First posted: 22 Aug 2011 (estimated)
Results: Posted 8 Sep 2014

Clinical summary

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

Detailed description

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
TR-701 FA	Experimental	Drug: TR-701 FA• TR-701 FA IV followed by TR-701 FA tablets
Linezolid	Active comparator	Drug: Linezolid• Linezolid IV followed by Linezolid Tablets

Who may qualify

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

Key inclusion criteria (2 listed)

Patients requiring IV antibiotic therapy and with systemic signs of infection diagnosed with ABSSSI.
Diagnosed with Cellulitis/ erysipelas, major cutaneous abscess, or wound infections

Key exclusion criteria (3 listed)

Uncomplicated skin infections
Severe sepsis or septic shock
ABSSSI solely due to gram-negative pathogens

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
TR-701 FA* TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion * TR-701 FA Tablets, 200 mg, orally once daily	Drug	TR-701 FA
Linezolid* Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion * Linezolid Tablets, 600 mg, orally every 12 hours	Drug	Linezolid

Primary outcome

The Early Clinical Response Rate
Time frame: 48-72 hours
Responder: No increase in lesion surface area from baseline.

7 secondary outcomes

Clinical Response at the End of Therapy Visit
Time frame: Day 11
Clinical Response at the End of Therapy Visit in the Clinically Evaluable at End of Therapy Analysis Set
Time frame: End of Therapy Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Success of the Post Therapy Evaluation Visit in Clinically Evaluable-Post Treatment Evaluation Analysis Set.
Time frame: Post-Treatment Evaluation (7-14 days after the End of Therapy)
Investigator's Assessment of Clinical Response at the 48-72 Hour Visit
Time frame: 48-72 Hours
Investigator's Assessment of Clinical Response at the Day-7 Visit
Time frame: Day 7
Change From Baseline in Patient-reported Pain, by Study Visit
Time frame: Multiple

Results and safety

Results posted to the registry on 8 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tedizolid Phosphate	332	313
Linezolid	334	306

Primary outcome: The Early Clinical Response Rate

Time frame: 48-72 hours. Number. Unit: participants

Measure	Tedizolid Phosphate n = 332	Linezolid n = 334
Value	283	276

Tedizolid Phosphate vs Linezolid: Risk Difference (RD): 2.6 (95% CI -3.0 to 8.2)

Population analysed: The Intent to Treat analysis set includes data from all randomized participants.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Collected from signing of the ICF through the late follow-up visit (up to 38 days).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tedizolid Phosphate	7 of 331 (2.1%)	84 of 331 (25.4%)	Not reported
Linezolid	9 of 327 (2.8%)	90 of 327 (27.5%)	Not reported

Limitations and caveats (from the sponsor): Analyses for this study were conducted using 2 statistical plans, 1 for the US FDA and 1 for the EMA, to address differing guidance on the development of antibacterials. These differences are reflected in the EudraCT and clinicaltrials.gov records.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28264845Sandison T, De Anda C, Fang E, Das AF, Prokocimer P. Clinical Response of Tedizolid versus Linezolid in Acute Bacterial Skin and Skin Structure Infections by Severity Measure Using a Pooled Analysis from Two Phase 3 Double-Blind Trials. Antimicrob Agents Chemother. 2017 Apr 24;61(5):e02687-16. doi: 10.1128/AAC.02687-16. Print 2017 May.
Derived from this study: PubMed 28003218Nathwani D, Corey R, Das AF, Sandison T, De Anda C, Prokocimer P. Early Clinical Response as a Predictor of Late Treatment Success in Patients With Acute Bacterial Skin and Skin Structure Infections: Retrospective Analysis of 2 Randomized Controlled Trials. Clin Infect Dis. 2017 Jan 15;64(2):214-217. doi: 10.1093/cid/ciw750. Epub 2016 Dec 21.
Derived from this study: PubMed 27530088Powers JH 3rd, Das AF, De Anda C, Prokocimer P. Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain. Contemp Clin Trials. 2016 Sep;50:265-72. doi: 10.1016/j.cct.2016.08.010. Epub 2016 Aug 13.
Derived from this study: PubMed 25421472Shorr AF, Lodise TP, Corey GR, De Anda C, Fang E, Das AF, Prokocimer P. Analysis of the phase 3 ESTABLISH trials of tedizolid versus linezolid in acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Feb;59(2):864-71. doi: 10.1128/AAC.03688-14. Epub 2014 Nov 24.
Derived from this study: PubMed 25246392Lodise TP, Fang E, Minassian SL, Prokocimer PG. Platelet profile in patients with acute bacterial skin and skin structure infections receiving tedizolid or linezolid: findings from the Phase 3 ESTABLISH clinical trials. Antimicrob Agents Chemother. 2014 Dec;58(12):7198-204. doi: 10.1128/AAC.03509-14. Epub 2014 Sep 22.
Derived from this study: PubMed 24909499Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2014 Aug;14(8):696-705. doi: 10.1016/S1473-3099(14)70737-6. Epub 2014 Jun 5.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Philippe G Prokocimer, MD study director

Trius Therapeutics

117 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Brazil, Russia, Argentina, South Africa and 6 more countries. 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 8 Sep 2014). 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?

The Early Clinical Response Rate (time frame: 48-72 hours). 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 NCT01421511, which also lists 6 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 29 Aug 2018.