Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients
|ClinicalTrials.gov Identifier: NCT01321879|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : December 7, 2016
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.
Evaluate the clinical efficacy and safety of Telavancin given for treatment of gram positive bacteremia in cancer patients (including neutropenics).
|Condition or disease||Intervention/treatment||Phase|
|Infection Bacteremia||Drug: Telavancin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open-Label Pilot Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
10 or 7.5 mg/kg intravenous daily
10 mg/kg by vein once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
Other Name: Vibativ
- Patient Response to Telavancin [ Time Frame: From baseline up to 6 weeks, assessed every 7 days ]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 signs and symptoms cannot be assessed).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321879
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Issam Raad, MD||M.D. Anderson Cancer Center|