Staphylococcal Skin InfectionPhase 3ATLAS2NCT00107978
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
A Phase 3 study testing Telavancin and Vancomycin in people with Staphylococcal Skin Infection, run by Cumberland Pharmaceuticals at 1 site in United States.
Trial summary
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Skin Infection
- What is being tested?
- Telavancin and Vancomycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,035 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to May 2006
- 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 must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
- major abscess requiring surgical incision and drainage;
- infected burn (see exclusion criteria for important qualifications);
- deep/extensive cellulitis;
- infected ulcer (see exclusion criteria for important qualifications);
- wound infections
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
Who cannot join
- Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center, Dept of Med/ER Med
New Orleans, Louisiana, 70112
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
- Conditions
- Staphylococcal Skin Infection
- Being tested
- Telavancin, Vancomycin
- Keywords
- cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)
- Medical subject headings
- Staphylococcal Skin Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelavancinDrug
Also called VIBATIV, TD-6424
Telavancin 10 mg/kg/day, IV for up to 14 days.
VancomycinDrug
Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Telavancin | Experimental | Not described Receives: Drug: Telavancin |
| Vancomycin | Active comparator | Not described Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs \& symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Measured: 7 to 14 days after the last antibiotic dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2005 (estimated)
- Study startFeb 2005
- Primary completionMay 2006
- Study completionMay 2006
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 (3)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal Skin InfectionStudies 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
- 1,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumberland Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- G. Ralph Corey, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107978
- Sponsor's protocol ID
- 0018
- Acronym
- ATLAS2
- Status last verified
- Jan 2019
- First submitted
- 11 Apr 2005
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.
PubMed 18444791Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.
PubMed 19095213Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13.
PubMed 22416054
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Multinational Trial of Intravenous Telavancin Versus Vancomycin for Treatment of Complicated Gram Positive Skin and Skin Structure Infections With a Focus on Patients With Infections Due to Methicillin-resistant Staphylococcus Aureus
- ClinicalTrials.gov ID
- NCT00107978
- Acronym / sponsor ID
- ATLAS2 / 0018
- Conditions
- Staphylococcal Skin Infection
- Keywords
- cSSSI (complicated Skin and Skin Structure Infections), Staph (Staphylococcus), MRSA (Methicillin-resistant Staphylococcus Aureus)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,035 participants (actual)
- Lead sponsor
- Cumberland PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 12 Apr 2005 (estimated)
- Results
- Posted 1 Feb 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 0018 (NCT00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
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 |
|---|---|---|
| Telavancin | Experimental | Drug: Telavancin |
| Vancomycin | Active comparator | Drug: Vancomycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have a diagnosis of one of the following complicated skin and skin structure infections with MRSA (Methicillin-resistant Staphylococcus Aureus) either suspected or confirmed as the major cause of the infection:
- Patients must be expected to require at least 7 days of intravenous antibiotic treatment.
Key exclusion criteria (2 listed)
- Received more than 24 hours of potentially effective systemic (IV/IM or PO) antibiotic therapy
- Burns involving > 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.
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 |
|---|---|---|
| TelavancinAlso: VIBATIV, TD-6424Telavancin 10 mg/kg/day, IV for up to 14 days. | Drug | Telavancin |
| VancomycinVancomycin 1 Gm IV administered every 12 hrs for up to 14 days. | Drug | Vancomycin |
Primary outcome
Clinical Response
Time frame: 7 to 14 days after the last antibiotic dose
The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs \& symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18444791Stryjewski ME, Graham DR, Wilson SE, O'Riordan W, Young D, Lentnek A, Ross DP, Fowler VG, Hopkins A, Friedland HD, Barriere SL, Kitt MM, Corey GR; Assessment of Telavancin in Complicated Skin and Skin-Structure Infections Study. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections caused by gram-positive organisms. Clin Infect Dis. 2008 Jun 1;46(11):1683-93. doi: 10.1086/587896.
- Results publication: PubMed 19095213Wilson SE, O'Riordan W, Hopkins A, Friedland HD, Barriere SL, Kitt MM; ATLAS Investigators. Telavancin versus vancomycin for the treatment of complicated skin and skin-structure infections associated with surgical procedures. Am J Surg. 2009 Jun;197(6):791-6. doi: 10.1016/j.amjsurg.2008.05.012. Epub 2008 Dec 18.
- Derived from this study: PubMed 22416054Stryjewski ME, Barriere SL, O'Riordan W, Dunbar LM, Hopkins A, Genter FC, Corey GR. Efficacy of telavancin in patients with specific types of complicated skin and skin structure infections. J Antimicrob Chemother. 2012 Jun;67(6):1496-502. doi: 10.1093/jac/dks081. Epub 2012 Mar 13.
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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.
G. Ralph Corey, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telavancin and Vancomycin in people with Staphylococcal Skin Infection, run by Cumberland Pharmaceuticals at 1 site 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 7 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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 1 Feb 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 Response (time frame: 7 to 14 days after the last antibiotic dose). 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 NCT00107978, which also lists 3 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 Jan 2019.