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CompletedNCT00107978ATLAS2Updated Jan 16, 2019Results posted

Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus

A Phase 3 interventional study of Telavancin and Vancomycin in Staphylococcal Skin Infection, sponsored by Cumberland Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Cumberland Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,035
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Staphylococcal Skin Infection

Keywords

  • cSSSI (complicated Skin and Skin Structure Infections)
  • Staph (Staphylococcus)
  • MRSA (Methicillin-resistant Staphylococcus Aureus)
03

In context

Staphylococcal Skin Infections

28 studies on the registry are indexed under Staphylococcal Skin Infections; none are open to participants now.

This study's enrollment of 1,035 is above the median of 202 across 26 interventional studies indexed under Staphylococcal Skin Infections.

Browse Staphylococcal Skin Infections studies →

Lead sponsor

Cumberland Pharmaceuticals is the lead sponsor of 49 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Browse Cumberland Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,035 participants (actual)

Study arms

  • Experimental
    Telavancin

    Drug: Telavancin

  • Active comparator
    Vancomycin

    Drug: Vancomycin

Interventions

  • DrugTelavancin

    Telavancin 10 mg/kg/day, IV for up to 14 days.

    Also known as: VIBATIV, TD-6424

  • DrugVancomycin

    Vancomycin 1 Gm IV administered every 12 hrs for up to 14 days.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 to 14 days after the last antibiotic dose

07

Results

Posted Feb 1, 2010

Participant flow

Enrollment Period: 18 February 2005 to 31 May 2006

Participant flow — Overall Study
MilestoneTelavancinVancomycin
Started458481
Completed425431
Not completed3350
Withdrew: Adverse event15
Withdrew: Death33
Withdrew: Lost to follow-up2028
Withdrew: Withdrawal by subject49
Withdrew: Protocol violation01
Withdrew: Other54

Outcome measures

PrimaryClinical 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.

Time frame:
7 to 14 days after the last antibiotic dose
Reported as:
Number · patients
Clinical Response
patientsTelavancinVancomycin
Cure358364
Not cured5957
Indeterminate1720
Missing2440
Statistical analysis
  • Telavancin vs Vancomycin · 2-sided 95% confidence interval · Risk difference (rd): 2.5 · 95% CI -2.9 to 7.92-sided 95% confidence interval calculated on the difference in cure rates between treatment groups.

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Telavancin—38/503 (7.6%)377/503 (75%)
Vancomycin—15/509 (2.9%)341/509 (67%)
Most frequent serious events
Showing 10 of 54
Most frequent serious events
EventTelavancinVancomycin
Renal Failure AcuteRenal and urinary disorders3/5030/509
AnemiaBlood and lymphatic system disorders3/5030/509
Blood creatinine increasedInvestigations3/5030/509
Myocardial InfarctionCardiac disorders2/5031/509
Drug HypersensitivityImmune system disorders2/5031/509
Mental Status ChangesPsychiatric disorders2/5030/509
Renal InsufficiencyRenal and urinary disorders2/5030/509
Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders2/5030/509
Blood Urea increasedInvestigations2/5030/509
DehydrationMetabolism and nutrition disorders2/5030/509
Most frequent other events
Showing 10 of 50
Most frequent other events
EventTelavancinVancomycin
DysgeusiaNervous system disorders155/50331/509
NauseaGastrointestinal disorders121/50347/509
PruritisSkin and subcutaneous tissue disorders29/50362/509
Urine AbnormalityRenal and urinary disorders53/50319/509
HeadacheNervous system disorders48/50351/509
VomitingGastrointestinal disorders49/50319/509
DiarrhoeaGastrointestinal disorders36/50335/509
ConstipationGastrointestinal disorders35/50324/509
InsomniaPsychiatric disorders19/50333/509
DizzinessNervous system disorders28/50318/509

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TelavancinVancomycinTotal
<=18 years000
Between 18 and 65 years377379756
>=65 years81102183
Age, Continuous
Age, Continuous(years)TelavancinVancomycinTotal
Mean49.2 ± 16.149.9 ± 17.049.5 ± 16.6
Sex: Female, Male
Sex: Female, Male(Participants)TelavancinVancomycinTotal
Female200187387
Male258294552
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)TelavancinVancomycinTotal
Hispanic or Latino7984163
Not Hispanic or Latino379397776
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)TelavancinVancomycinTotal
American Indian or Alaska Native7916
Asian384482
Native Hawaiian or Other Pacific Islander4812
Black or African American6974143
White336343679
More than one race437
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)TelavancinVancomycinTotal
United States287310597
South Africa6612
Argentina353368
Canada352964
Chile123
France022
Germany044
Italy213
Korea, Republic of141630
Lithuania12618
Peru415
Poland384381
Spain235
Taiwan202545
United Kingdom202
Diabetes Status
Diabetes Status(Participants)TelavancinVancomycinTotal
Diabetic113118231
Not diabetic345363708
08

Study locations

1 site
  • Louisiana State University Health Sciences Center, Dept of Med/ER Med
    New Orleans, Louisiana 70112, United States
09

References and documents

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 18444791 ↗
  • Wilson 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 19095213 ↗
  • Stryjewski 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 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2005, a primary completion of May 2006 and a completion of May 2006. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2010, 3 years 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2005
First posted
Apr 12, 2005
Start
Feb 2005
Primary completionActual
May 2006
CompletionActual
May 2006
Results first posted
Feb 1, 2010
Last update
Jan 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00107978
Lead sponsor
Cumberland Pharmaceuticals
First posted
Apr 12, 2005
Start date
Feb 2005
Primary completion
May 2006
Completion
May 2006
Results posted
Feb 1, 2010
Last update
Jan 16, 2019

Study contacts

G. Ralph Corey, MD
principal investigator · Duke University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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