Study to Evaluate the Safety and Efficacy of Telavancin in the Treatment of Gram Positive Bloodstream Infections in Cancer Patients

NCT01321879 | Completed Phase 2 Results

• 2 other identifiers: 2010-0454NCI-2011-00752
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infection; Bacteremia

Keywords

Gram Positive Bloodstream Infections; Sepsis; Staphylococcus aureus; Enterococci; Streptococci; Pneumococci; Corynebacterium; Propionibacterium or Bacillus species; Telavancin; Vibativ

Outcome Measures

Primary Outcomes (1)

• Patient Clinical Response to Telavancin

  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).

  From baseline up to 6 weeks, assessed every 7 days

Study Arms (1)

Telavancin

EXPERIMENTAL

10 or 7.5 mg/kg intravenous daily

Drug: Telavancin

Interventions

Telavancin DRUG

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.

Also known as: Vibativ

Telavancin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with probable or definite diagnosis of uncomplicated gram positive bacteremia that have at least one positive blood culture including 20 patients with Staphylococcus aureus and the other 20 patients will include any of the following organism ( CNS, Enterococci, streptococci, pneumococci, Corynebacterium, and Propionibacterium or Bacillus species).If the positive blood culture involves a commensal skin organism such as CNS, Corynebacterium, Propionibacterium, Micrococcus and Bacillus, then at least \> 100 colonies/ml will be required or a time to positivity =/\< 16 hours (as it has been shown to reflect a high grade bacteremia), or two positive blood cultures. (Time to positivity of a blood culture bottle is recorded in the microbiology laboratory by the automatic culture detector (Bactec 9240 and Bactec Plus Aerobic/F; Becton Dickinson) which records culture positivity every 15 min according to changes in fluorescence related to microbial growth).
• Patients must have at least two signs of sepsis from the list below, in any combination at any time, within 48 hours prior to Telavancin therapy: a. Core temperature =/\>38.0 degrees C or =/\<36.0 degrees C, measured orally, rectally, tympanic ally or via a central catheter. If auxiliary add 0.5 degrees C to the measured temperature; b. Pulse rate =/\> 100 beats/min.; c. Respiratory rate =/\> 20/min.; d. WBC count =/\>12,000/mm\^3, =/\<4,000/mm or differential count showing \>10% band forms; e. Systolic blood pressure =/\<90 mm Hg. Patient will still be eligible for the study if the participants white blood cell count (WBC) is outside normal limits due to chemotherapy treatment or underlying conditions.
• Male or non-pregnant, non-lactating females with an age of greater than or equal to 18 years.
• Signed informed consent.
• Female patients must be at no risk for pregnancy for one of the following reasons: - Postmenopausal for at least one year - Post-hysterectomy and/or post-bilateral ovariectomy - If of childbearing potential, having a negative serum human chorionic gonadotropin (hCG) pregnancy test with in 5 days prior to enrollment and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study.

You may not qualify if:

• Estimated Serum Creatinine Clearance \<30 mL/min (according to Cock-Gault-formula using ideal body weight) at the time gram positive bacteremia was diagnosed unless the patient is on dialysis.
• Bilirubin \>4x the upper limit of normal at the time gram positive bacteremia was diagnosed.
• Treatment with an antibiotic, such as vancomycin, linezolid, tigecycline or Telavancin, effective against resistant gram positive bacterial infections, such as methicillin resistant staphylococci, for more than 48 hours within 72 hours of study medication initiation, unless treatment failed that is defined as a persistent fever and/or leukocytosis for 72 hours or longer of appropriate antibiotics treatment.
• History of hypersensitivity to lipoglycopeptides.
• Presence of deep-sited intravascular source of infection with same organism cultured from blood, e.g. endocarditis (as evidenced by vegetations on an echocardiogram), or septic thrombosis.
• Presence of a prosthetic valve.
• Oliguria defined as urine output of \<20 cc/hour averaged over 24 hours.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Theravance Biopharma: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Chaftari AM, Hachem R, Jordan M, Garoge K, Al Hamal Z, El Zakhem A, Viola GM, Granwehr B, Mulanovich V, Gagel A, Reitzel R, Yousif A, Jiang Y, Raad I. Case-Control Study of Telavancin as an Alternative Treatment for Gram-Positive Bloodstream Infections in Patients with Cancer. Antimicrob Agents Chemother. 2015 Oct 19;60(1):239-44. doi: 10.1128/AAC.00617-15. Print 2016 Jan.

  PMID: 26482312 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Infections; Bacteremia; Sepsis; Staphylococcal Infections

Interventions

telavancin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Results Point of Contact

• Title: Dr. Issam I. Raad/ Chair, Infectious Diseases
• Organization: UT MD Anderson Cancer Center

iraad@mdanderson.org

713- 792-7943

Study Officials

• Issam Raad, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 24, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Locations

US (1)