Bacterial InfectionsPhase 3NCT00423657

Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

A Phase 3 study testing ceftaroline and vancomycin plus aztreonam in people with Bacterial Infections, run by Forest Laboratories at 54 sites in 12 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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults. 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?: ceftaroline and vancomycin plus aztreonam
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 680 participants
Where: 54 sitesin 12 countries
Study dates: Mar 2007to Dec 2007
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

Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Who cannot join

Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Trial locations and contacts

54 sites in 12 countries.

Country

City, postcode or hospital

54 sites in 12 countries

United States17 sites

Investigational Site
Atlantis, Florida, 33462
Investigational Site
Baltimore, Maryland, 21201
Investigational Site
Buena Park, California, 90620
Investigational Site
Butte, Montana, 59701
Investigational Site
Columbus, Georgia, 31904
Investigational Site
Hawaiian Gardens, California, 90716
Investigational Site
Los Angeles, California, 90033
Investigational Site
Marietta, Georgia, 30060
Investigational Site
Milwaukee, Wisconsin, 53215
Investigational Site
Minneapolis, Minnesota, 55422
Investigational Site
Pasadena, California, 91105
Investigational Site
San Diego, California, 92114
Investigational Site
San Jose, California, 95124
Investigational Site
Somers Point, New Jersey, 08244
Investigational Site
Springfield, Illinois, 62701
Investigational Site
Tacoma, Washington, 98405
Investigational Site
Toledo, Ohio, 43608

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Poland9 sites

Investigational Site
Bielsko-Biala, 43-316
Investigational Site
Krakow, 31-501
Investigational Site
Krakow, 31-820
Investigational Site
Lodz, 91-425
Investigational Site
Lublin, 20-954
Investigational Site
Poznan, 61-848
Investigational Site
Warsaw, 02-097
Investigational Site
Warsaw, 03-401
Investigational Site
Wroclaw, 50-326

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Germany5 sites

Investigational Site
Cottbus, 03048
Investigational Site
Dortmund, 44145
Investigational Site
Homburg/Saar, D-66421
Investigational Site
Mainz, D-55101
Investigational Site
Wiesbaden, 65191

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Russia5 sites

Investigational Site
Moscow, 111020
Investigational Site
Moscow, 119048
Investigational Site
Moscow Region, 143405
Investigational Site
Saint Petersburg, 192242
Investigational Site
Saint Petersburg

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Ukraine4 sites

Investigational Site
Kharkiv, 61176
Investigational Site
Kyiv, 03110
Investigational Site
Lviv, 79044
Investigational Site
Zaporizhya, 69000

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Argentina3 sites

Investigational Site
Buenos Aires
Investigational Site
Córdoba
Investigational Site
Santa Fe

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Austria3 sites

Investigational Site
Braunau am Inn
Investigational Site
Graz, 8036
Investigational Site
Sankt Pölten, 3100

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Chile2 sites

Investigational Site
Temuco
Investigational Site
Valdivia

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Mexico2 sites

Investigational Site
Guadalajara, Jalisco, 44280
Investigational Site
Seattle Zapopan, Jalisco, 45170

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United Kingdom2 sites

Investigational Site
London, N19 5LW
Investigational Site
London, SW10 9NH

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Brazil1 site

Investigational Site
Sao Paula

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Latvia1 site

Investigational Site
Riga, LV-1001

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About this study

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Read the detailed description

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Conditions: Bacterial Infections
Being tested: ceftaroline, vancomycin plus aztreonam, Placebo
Keywords: Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis, Cephalosporin, Complicated skin and skin structure infection (cSSSI), cSSSI, Intravenous, Methicillin-resistant Staphylococcus Aureus (MRSA), PPI-0903, Prodrug, Skin disease, bacterial, Skin infection, Staphylococcal skin infection, Staphylococcus aureus, Streptococcal skin infection
Medical subject headings: Bacterial Infections, Abscess, Skin Diseases, Bacterial, Cellulitis, Staphylococcal Skin Infections, Staphylococcal Infections, Surgical Wound Infection

What participants receive

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

ceftarolineDrug
Also called Experimental
600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days
vancomycin plus aztreonamDrug
Also called Active Comparator
vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.
PlaceboDrug
Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.

Study groups in NCT00423657
Study group	Role	What they receive
Ceftaroline fosamil for Injection	Experimental	Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours. Receives: Drug: ceftaroline; Drug: Placebo
IV Vancomycin plus IV Aztreonam	Active comparator	Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours. Receives: Drug: vancomycin plus aztreonam

What is being measured

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

Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary.
Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI.
Indeterminate: Inability to determine an outcome
Measured: 8-15 days after last dose of study drug administration
The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.
Measured: 8-15 days after last dose of study drug

Secondary outcomes (6)

To Evaluate the Microbiological Success Rate at the TOC Visit
Measured: 8-15 days after the last dose of study drug
To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
Measured: last day of study drug administration
To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
Measured: 8-15 days after last dose of study drug
To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit
Measured: 21 to 35 days after the last dose of study drug
To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
Measured: 21-35 days after last dose of study drug
To Evaluate Safety
Measured: first study drug dose through TOC

Timeline

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

Mar 2007Dec 2007

First posted18 Jan 2007 (estimated)
Study startMar 2007
Primary completionDec 2007
Study completionDec 2007

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 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: 680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00423657
Sponsor's protocol ID: P903-07
Status last verified: Feb 2017
First submitted: 16 Jan 2007
Last updated: 14 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
PubMed 34922058
Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
PubMed 34741280
Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
PubMed 30716446
Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
PubMed 30597021
Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
PubMed 21115456
Wilcox MH, Corey GR, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 2 investigators. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255.
PubMed 21115455
Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.
PubMed 20695801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline Versus Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin and Skin Structure Infection (cSSSI)
ClinicalTrials.gov ID: NCT00423657
Acronym / sponsor ID: P903-07
Conditions: Bacterial Infections
Keywords: Abscess, Antibacterial, Antibiotic, Antimicrobial, Bacterial infection, skin, Ceftaroline, Ceftaroline acetate, Cellulitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 680 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 18 Jan 2007 (estimated)
Results: Posted 18 Nov 2010

Clinical summary

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

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Detailed description

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

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
Ceftaroline fosamil for Injection	Experimental	Drug: ceftaroline, Drug: PlaceboCeftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
IV Vancomycin plus IV Aztreonam	Active comparator	Drug: vancomycin plus aztreonamVancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.

Who may qualify

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

Key inclusion criteria (1 listed)

Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Key exclusion criteria (2 listed)

Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

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
ceftarolineAlso: Experimental600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days	Drug	Ceftaroline fosamil for Injection
vancomycin plus aztreonamAlso: Active Comparatorvancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days.	Drug	IV Vancomycin plus IV Aztreonam
PlaceboCeftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.	Drug	Ceftaroline fosamil for Injection

Primary outcome

Clinical Cure Rate at Test of Cure (TOC) (MITT Population)
Time frame: 8-15 days after last dose of study drug administration
Cure: Total resolution of all signs and symptoms of the baseline infection, or improvement of the infection such that no further antimicrobial therapy was necessary. Failure: Requirement of alternative antimicrobial therapy for primary infection of complicated skin and skin structure infection (cSSSI) due to inadequate response, recurrence, new infection at the same site; treatment-limiting adverse event (AE); requirement for surgery due to failure of study drug; diagnosis of osteomyelitis after Study Day 8; or death caused by cSSSI. Indeterminate: Inability to determine an outcome
The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.
Time frame: 8-15 days after last dose of study drug

6 secondary outcomes

To Evaluate the Microbiological Success Rate at the TOC Visit
Time frame: 8-15 days after the last dose of study drug
To Evaluate the Clinical Response at the End of Therapy (EOT) Visit
Time frame: last day of study drug administration
To Evaluate the Clinical and Microbiological Response by Pathogen at the TOC Visit
Time frame: 8-15 days after last dose of study drug
To Evaluate Clinical Relapse at the Late Follow Up (LFU) Visit
Time frame: 21 to 35 days after the last dose of study drug
To Evaluate Microbiological Reinfection or Recurrence at the LFU Visit
Time frame: 21-35 days after last dose of study drug
To Evaluate Safety
Time frame: first study drug dose through TOC

Results and safety

Results posted to the registry on 18 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ceftaroline for Injection	342	316
IV Vancomycin Plus IV Aztreonam	338	313

Primary outcome: Clinical Cure Rate at Test of Cure (TOC) (MITT Population)

Time frame: 8-15 days after last dose of study drug administration. Number. Unit: participants

Measure	Ceftaroline for Injection n = 342	IV Vancomycin Plus IV Aztreonam n = 338
Clinical Cure	291	289
Clinical Failure	25	28
Indeterminate	26	21

Ceftaroline for Injection vs IV Vancomycin Plus IV Aztreonam: Risk Difference (RD): -0.4 (95% CI -5.8 to 5.0)

Population analysed: MITT (Modified Intent to Treat) - all subjects that received any amount of study drug

Primary outcome: The Primary Efficacy Outcome Measure Was the Per-subject Clinical Cure Rate at the TOC Visit in the Clinically Evaluable (CE) Populations.

Time frame: 8-15 days after last dose of study drug

The sponsor has not posted figures for this outcome.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ceftaroline for Injection	14 of 341 (4.1%)	144 of 341 (42.2%)	Not reported
IV Vancomycin Plus IV Aztreonam	16 of 339 (4.7%)	159 of 339 (46.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34922058Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
Derived from this study: PubMed 34741280Wilcox M, Yan JL, Gonzalez PL, Dryden M, Stone GG, Kantecki M. Impact of Underlying Comorbidities on Outcomes of Patients Treated with Ceftaroline Fosamil for Complicated Skin and Soft Tissue Infections: Pooled Results from Three Phase III Randomized Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):217-230. doi: 10.1007/s40121-021-00557-w. Epub 2021 Nov 6.
Derived from this study: PubMed 30716446Corey GR, Wilcox MH, Gonzalez J, Jandourek A, Wilson DJ, Friedland HD, Das S, Iaconis J, Dryden M. Ceftaroline fosamil therapy in patients with acute bacterial skin and skin-structure infections with systemic inflammatory signs: A retrospective dose comparison across three pivotal trials. Int J Antimicrob Agents. 2019 Jun;53(6):830-837. doi: 10.1016/j.ijantimicag.2019.01.016. Epub 2019 Feb 1.
Derived from this study: PubMed 30597021Cheng K, Pypstra R, Yan JL, Hammond J. Summary of the safety and tolerability of two treatment regimens of ceftaroline fosamil: 600 mg every 8 h versus 600 mg every 12 h. J Antimicrob Chemother. 2019 Apr 1;74(4):1086-1091. doi: 10.1093/jac/dky519.
Derived from this study: PubMed 21115456Corrado ML. Integrated safety summary of CANVAS 1 and 2 trials: Phase III, randomized, double-blind studies evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv67-iv71. doi: 10.1093/jac/dkq256.
Derived from this study: PubMed 21115455Wilcox MH, Corey GR, Talbot GH, Thye D, Friedland D, Baculik T; CANVAS 2 investigators. CANVAS 2: the second Phase III, randomized, double-blind study evaluating ceftaroline fosamil for the treatment of patients with complicated skin and skin structure infections. J Antimicrob Chemother. 2010 Nov;65 Suppl 4:iv53-iv65. doi: 10.1093/jac/dkq255.
Derived from this study: PubMed 20695801Corey GR, Wilcox M, Talbot GH, Friedland HD, Baculik T, Witherell GW, Critchley I, Das AF, Thye D. Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis. 2010 Sep 15;51(6):641-50. doi: 10.1086/655827.

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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.

Mark Wilcox, MD principal investigator

Old Medical School

54 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ceftaroline and vancomycin plus aztreonam in people with Bacterial Infections, run by Forest Laboratories at 54 sites in 12 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 1 inclusion and 2 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States, Poland, Germany, Russia, Ukraine and 7 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 18 Nov 2010). 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?

Clinical Cure Rate at Test of Cure (TOC) (MITT Population) (time frame: 8-15 days after last dose of study drug administration). The study lists 2 primary outcomes in all. 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 NCT00423657, 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 14 Mar 2017.