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NCT01321879 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
A Phase 2 study of Infection and Bacteremia, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01321879: Completed Phase 2 study of Infection and Bacteremia, sponsored by M.D. Anderson Cancer Center.
NCT01321879 is a Phase 2 study of Infection and Bacteremia that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01321879, a Phase 2 study of Infection and Bacteremia, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if Vibativ (telavancin) can help to control blood stream infections (BSIs). The safety of this treatment will also be studied. Objectives: Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in cancer patients (including neutropenics).
Primary Outcome
Clinical response assessed: Cure (No fever/chills or symptoms + eradication causing organism); Improvement (Resolution local/systemic symptoms + no new systemic antibacterial treatment); Failure (IF one or more following: Persistence 1+ symptoms \[fever/chills\] + new systemic anti gram positive treatment, \> 72 hours after initiation study drug; or Relapse within 1 month completing antibiotic therapy; or Development of deep-seated infection not previously assessed); Indeterminate (clinical sign
Conditions Studied
Interventions
- DRUG Telavancin
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-03 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT01321879 record still lists
NCT01321879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 725-participant average among 41 other Infection trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Infection appearing as the primary indexed condition, and to 1 intervention - of which Telavancin is the first listed.
NCT01321879 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01321879 about?
NCT01321879 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients". The goal of this clinical research study is to learn if Vibativ (telavancin) can help to control blood stream infections (BSIs). The safety of this treatment will also be studied. Objectives: Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in...
What is the current status of trial NCT01321879?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2011-03. Estimated completion is 2016-12.
What conditions does trial NCT01321879 study?
This clinical trial studies the following conditions: Infection, Bacteremia.
What interventions are being tested in trial NCT01321879?
The interventions under investigation include: Telavancin (DRUG).
Who is sponsoring clinical trial NCT01321879?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01321879 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01321879's enrollment target sits among peer trials
40 30th of 41 higher than 11 of 41 other Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infection 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.
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