Skin and Subcutaneous Tissue Bacterial InfectionsPhase 3ABSSSINCT01170221

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 84 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 Phase 3 study of oral TR-701 FA 200 mg once daily for 6 days versus oral Zyvox® (linezolid) 600 mg every 12 hours for 10 days for the treatment of ABSSSI in adults. Approximately 75 to 100 sites globally will participate in this study. 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
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 667 participants
Where: 84 sitesin 11 countries
Study dates: 15 Aug 2010to 30 Sep 2011
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 with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (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

84 sites in 11 countries.

Country

City, postcode or hospital

84 sites in 11 countries

United States30 sites

Trius Investigator site 130
Anaheim, California, 92801
Trius investigator site 118
Anaheim, California, 92804
Trius investigator site 129
Buena Park, California, 90620
Trius investigator site 133
Butte, Montana, 59701
Trius Investigator site 116
Chicago, Illinois, 60637
Trius Investigator Site 103
Chula Vista, California, 91911
Trius investigator site 101
Columbus, Georgia, 31904
Trius Investigator Site 107
Detroit, Michigan, 48202
Trius investigator site 109
Dothan, Alabama, 36301
Trius investigator site 112
Evansville, Indiana, 47714
Trius investigator site 127
Fort Lauderdale, Florida, 33308
Trius investigator site 135
Hialeah, Florida, 33012
Trius investigator site 122
Houston, Texas, 77002
Trius investigator site 120
Houston, Texas, 77005
Trius investigator site 131
Houston, Texas, 77081
Trius Investigator site 121
Houston, Texas, 77093
Trius Investigator Site 105
La Mesa, California, 91942
Trius investigator site 126
Laguna Beach, California, 92651
Trius investigator site 128
Las Vegas, Nevada, 89109
Trius investigator site 125
Norwalk, California, 90650
Trius Investigator Site 104
Oceanside, California, 92056
Trius investigator site 113
Oxnard, California, 93030
Trius investigator site 123
Pasadena, California, 91105
Trius Investigator Site 106
Rolling Hills Estates, California, 90274
Trius Investigator Site 102
Savannah, Georgia, 31406
Trius investigator site 115
Somers Point, New Jersey, 08244
Trius Investigator Site 108
Springfield, Illinois, 62701
Trius investigator site 114
Toledo, Ohio, 43608
Trius investigator site 111
Torrance, California, 90501
Trius investigator site 132
Torrance, California, 90502

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Ukraine12 sites

Trius investigator site 271
Cherkassy, 18009
Trius investigator site 264
Dnipro, 49000
Trius investigator site 263
Dnipro, 49600
Trius investigator site 269
Ivano-Frankivsk, 07618
Trius investigator site 260
Kharkiv, 61037
Trius investigator site 261
Kyiv, 03110
Trius investigator site 268
Lviv, 79000
Trius investigator site 265
Lviv, 79044
Trius Investigator site 270
Ternopil, 46000
Trius investigator site 266
Uzhhorod, 88018
Trius investigator site 262
Zaporizhzhya, 69032
Trius investigator site 267
Zhytomyr, 10002

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Argentina10 sites

Trius investigator site 307
Avellaneda, Pcia Buenos Aires, B1870CID
Trius investigator site 309
Buenos Aires, C1181ACH
Trius investigator site 310
Buenos Aires, C1405CNF
Trius Investigator site 301
Córdoba, cp5000
Trius investigator site 305
Córdoba, X5000AAI
Trius investigator site 300
Córdoba, X5000FAL
Trius investigator site 304
Loma Hermosa, Pcia Buenos Aires, 1657
Trius investigator site 308
Paraná, E3100BBJ
Trius investigator site 303
Rosario, S2002QEA
Trius investigator site 306
Santa Fe, S3000EOY

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Canada6 sites

Trius investigator site 175
Brownsburg, Quebec, 46112
Trius investigator site 173
Chicoutimi, Quebec, G7H 5H6
Trius investigator site 172
Hamilton, Ontario, L8N 4A6
Trius investigator site 171
Hamilton, Ontario, L8N3Z5
Trius investigator site 174
Sherbrooke, Quebec, J1H 5N4
Trius investigator site 170
Winnipeg, Manitoba, R3A 1R9

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Czechia5 sites

Trius investigator site 234
Hradec Králové, 500 05
Trius investigator site 235
Mělník, 276 01
Trius investigator site 233
Ostrava, 708 52
Trius investigator site 236
Pardubice, 532 03
Trius investigator site 231
Prague, 180 81

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Brazil4 sites

Trius investigator site 322
Barro Preto, Belo Horizonte, 30140062
Trius investigator site 320
Belo Horizonte, MG - 30150221
Trius investigator site 321
São José do Rio Preto, São Paulo, CEP 15090 000
Trius investigator site 323
São Paulo, São Paulo, 04038-705

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Germany4 sites

Trius investigator site 201
Berlin, 10117
Trius investigator site 202
Hanau, 63450
Trius investigator site 200
Mannheim, 68135
Trius investigator site 203
Plauen, 08529

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Latvia4 sites

Trius investigator site 258
Daugavpils, LV- 5417
Trius investigator site 256
Liepāja, LV -3414
Trius investigator site 257
Rēzekne, LV-4600
Trius investigator site 255
Riga, LV-1002

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Peru4 sites

Trius investigator site 340
Arequipa, 054
Trius investigator site 343
Lima Cercado, Lima region, 01
Trius investigator site 342
Miraflores, Lima region, 18
Trius investigator site 341
San Juan de Miraflores, Lima region, 29

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Hungary3 sites

Trius investigator site 241
Debrecen, H-4032
Trius investigator site 242
Komló, H-7300
Trius investigator site 240
Szeged, H-6721

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Slovakia2 sites

Trius investigator site 251
Banská Bystrica, 97517
Trius investigator site 250
Martin, 036 59

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About this study

Official title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Approximately 75 to 100 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 in the early clinical response rate of 6 day oral TR-701 FA compared with that of 10-day oral linezolid treatment at the 48-72 Hour Visit in the ITT analysis set in patients with 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
Also called Tedizolid Phosphate, TR-700 active moiety
Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
LinezolidDrug
Also called Trade name = Zyvox, Generic name = linezolid
Oral Linezolid 600 mg twice daily for 10 days

Study groups in NCT01170221
Study group	Role	What they receive
TR-701 FA	Experimental	TR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo Receives: Drug: TR-701 FA
Linezolid	Active comparator	Linezolid 600 mg tablets oral twice a day for 10 days Receives: Drug: Linezolid

What is being measured

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

Early Clinical Response Rate
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Measured: 48-72 hours

Secondary outcomes (7)

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C.
Measured: Day 11
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C
Measured: EOT Day 11
Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit
Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, if present at baseline, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary lesion.
Measured: Post-Treatment Evaluation (7-14 days after the End of Therapy)
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the Clinically Evaluable-Post Treatment Evaluation Analysis Set
Clinical success defined as resolution/near resolution of most disease-specific signs and symptoms, absence/near resolution of systemic signs of infection, no new signs, symptoms, or complications attributable to the ABSSSIs so no further antibiotic therapy was required for the treatment of the primary 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 was defined as improvement in overall clinical status.
Measured: 48-72 Hour Visit
Investigator's Assessment of Clinical Response at the Day 7 Visit
Clinical improvement was 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 Aug 201030 Sep 2011

First posted27 Jul 2010 (estimated)
Study start15 Aug 2010
Primary completion30 Sep 2011
Study completion30 Sep 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 (7)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: 667 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01170221
Sponsor's protocol ID: 1986-009
Other IDs: TR701-112
Acronym: ABSSSI
Status last verified: Jul 2018
First submitted: 23 Jul 2010
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
Bien P, De Anda C, Prokocimer P. Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study. Surg Infect (Larchmt). 2014 Apr;15(2):105-10. doi: 10.1089/sur.2013.070. Epub 2014 Jan 22.
PubMed 24450727
Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013 Feb 13;309(6):559-69. doi: 10.1001/jama.2013.241.
PubMed 23403680

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 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections
ClinicalTrials.gov ID: NCT01170221
Acronym / sponsor ID: ABSSSI / 1986-009
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: 667 participants (actual)
Lead sponsor: Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 15 Aug 2010 (actual)
Primary completion: 30 Sep 2011 (actual)
Study completion: 30 Sep 2011 (actual)
First posted: 27 Jul 2010 (estimated)
Results: Posted 3 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 FATR0-701 FA 200 mg tablets once a day for six days followed by 4 days of placebo
Linezolid	Active comparator	Drug: LinezolidLinezolid 600 mg tablets oral twice a day 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 (2 listed)

Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (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 FAAlso: Tedizolid Phosphate, TR-700 active moietyOral TR-701 FA 200 mg once daily for six days followed by four days of placebo.	Drug	TR-701 FA
LinezolidAlso: Trade name = Zyvox, Generic name = linezolidOral Linezolid 600 mg twice daily for 10 days	Drug	Linezolid

Primary outcome

Early Clinical Response Rate
Time frame: 48-72 hours
Responder: No increase in lesion surface area from baseline and oral temperature ≤37.6°C

7 secondary outcomes

Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit.
Time frame: Day 11
Clinical Response at 48-72 Hours That is Sustained at the End of Therapy Visit in the Clinically Evaluable-End of Therapy Analysis Sets
Time frame: EOT 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)
To Compare the Investigator's Assessment of Clinical Success at the Post Treatment Evaluation Visit in the 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 Hour Visit
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 3 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	299
Linezolid	335	307

Primary outcome: Early Clinical Response Rate

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

Measure	Tedizolid Phosphate n = 332	Linezolid n = 335
Value	264 (-6.1 to 6.2)	266 (-6.1 to 6.2)

Tedizolid Phosphate vs Linezolid: Risk Difference (RD): 0.1 (95% CI -6.1 to 6.2)

Population analysed: The ITT 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	5 of 331 (1.5%)	84 of 331 (25.4%)	Not reported
Linezolid	4 of 335 (1.2%)	100 of 335 (29.9%)	Not reported

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 24450727Bien P, De Anda C, Prokocimer P. Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study. Surg Infect (Larchmt). 2014 Apr;15(2):105-10. doi: 10.1089/sur.2013.070. Epub 2014 Jan 22.
Derived from this study: PubMed 23403680Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin structure infections: the ESTABLISH-1 randomized trial. JAMA. 2013 Feb 13;309(6):559-69. doi: 10.1001/jama.2013.241.
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

84 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 84 sites in United States, Ukraine, Argentina, Canada, Czechia 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 3 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?

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 NCT01170221, which also lists 7 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.