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NCT01209078 · ClinicalTrials.gov registry record · Phase 2

GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection

A Phase 2 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
84
Enrollment target

NCT01209078: Completed Phase 2 study, sponsored by GlaxoSmithKline.

NCT01209078 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01209078, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
84 participants
Enrollment target

Study Summary

This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

Primary Outcome

An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical o

Interventions

  • DRUG Linezolid
  • DRUG GSK1322322
  • DRUG GSK1322322 placebo
  • DRUG Linezolid placebo

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2010-08-17
Est. Completion 2011-01-18
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the finished NCT01209078 record still lists

NCT01209078 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).

The record links to 0 conditions, and to 4 interventions - of which Linezolid is the first listed.

NCT01209078 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01209078 about?

NCT01209078 is a clinical study titled "GSK1322322 Versus Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infection". This study will determine the safety, tolerability and efficacy of GSK1322322 verses Linezolid in subjects with Acute Bacterial Skin and Skin Structure Infection (ABSSSI).

What is the current status of trial NCT01209078?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2010-08-17. Estimated completion is 2011-01-18.

What interventions are being tested in trial NCT01209078?

The interventions under investigation include: Linezolid (DRUG), GSK1322322 (DRUG), GSK1322322 placebo (DRUG), Linezolid placebo (DRUG).

Who is sponsoring clinical trial NCT01209078?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01209078's enrollment target sits among peer trials

84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01209078, the US trial registry maintained by the National Library of Medicine. NCT01209078 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.