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NCT00107978 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Cumberland Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
1,035
Enrollment target

NCT00107978: Completed Phase 3 study, sponsored by Cumberland Pharmaceuticals.

NCT00107978 is a Phase 3 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 1,035 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00107978, a Phase 3 study, has completed, sponsored by Cumberland Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
1,035 participants
Enrollment target

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.

Primary Outcome

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.

Interventions

  • DRUG Vancomycin
  • DRUG Telavancin

Trial Details

FieldValue
Enrollment Target 1,035 participants
Start Date 2005-02
Est. Completion 2006-05
Phase Phase 3
Cumberland Pharmaceuticals

43 total trials

What the finished NCT00107978 record still lists

NCT00107978 is an interventional study that assigns participants to a tested intervention. Its 1,035 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (34% higher).

The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.

NCT00107978 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00107978 about?

NCT00107978 is a clinical study titled "Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on 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.

What is the current status of trial NCT00107978?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,035 participants. The study started on 2005-02. Estimated completion is 2006-05.

What interventions are being tested in trial NCT00107978?

The interventions under investigation include: Vancomycin (DRUG), Telavancin (DRUG).

Who is sponsoring clinical trial NCT00107978?

This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00107978's enrollment target sits among peer trials

1,035 287th of 2000 higher than 1,713 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00107978, the US trial registry maintained by the National Library of Medicine. NCT00107978 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.