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Trial record 2 of 20 for:    Oxacillin

Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00062647
Recruitment Status : Completed
First Posted : June 12, 2003
Results First Posted : March 22, 2011
Last Update Posted : January 16, 2019
Sponsor:
Information provided by:
Cumberland Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gram-Positive Bacterial Infections
Interventions Drug: Telavancin
Drug: Vancomycin, nafcillin, oxacillin, or cloxacillin
Enrollment 60
Recruitment Details Enrollment period: 14 Aug 2003 to 02 Aug 2006
Pre-assignment Details  
Arm/Group Title Telavancin Standard Therapy
Hide Arm/Group Description Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Period Title: Overall Study
Started 30 30
Completed 14 17
Not Completed 16 13
Reason Not Completed
Death             2             2
Adverse Event             1             1
Withdrawal by Subject             2             1
Protocol Violation             1             0
Lost to Follow-up             1             2
Failed continuation criteria             4             2
Other             4             4
Never received study treatment             1             1
Arm/Group Title Telavancin Standard Therapy Total
Hide Arm/Group Description Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy. Total of all reporting groups
Overall Number of Baseline Participants 29 29 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  62.1%
18
  62.1%
36
  62.1%
>=65 years
11
  37.9%
11
  37.9%
22
  37.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 29 participants 58 participants
60  (19) 60  (17.9) 60  (17.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Female
11
  37.9%
14
  48.3%
25
  43.1%
Male
18
  62.1%
15
  51.7%
33
  56.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Hispanic or Latino
7
  24.1%
7
  24.1%
14
  24.1%
Not Hispanic or Latino
22
  75.9%
22
  75.9%
44
  75.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
American Indian or Alaska Native
1
   3.4%
1
   3.4%
2
   3.4%
Asian
2
   6.9%
4
  13.8%
6
  10.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
  31.0%
3
  10.3%
12
  20.7%
White
17
  58.6%
21
  72.4%
38
  65.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 29 participants 58 participants
Argentina 3 2 5
Singapore 1 3 4
Spain 2 3 5
United States 22 21 43
Hong Kong 1 0 1
1.Primary Outcome
Title Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation
Hide Description Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.
Time Frame 12 weeks after start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.
Arm/Group Title Telavancin Standard Therapy
Hide Arm/Group Description:
Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
Overall Number of Participants Analyzed 8 9
Measure Type: Number
Unit of Measure: participants
Cured 7 8
Failure 1 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telavancin, Standard Therapy
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments No margin was justified owing to the exploratory nature of the investigation.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method the difference in the 2 eradication rate
Comments Statistical testing was limited to interval estimation (95% CI) of the difference in the 2 eradication rates using the method of Agresti and Caffo.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 1
Confidence Interval 95%
-35.5 to 31.9
Estimation Comments [Not Specified]
Time Frame From receipt of first dose through last follow-up assessment (up to Day 98).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Telavancin Standard Therapy
Hide Arm/Group Description Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy. Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
All-Cause Mortality
Telavancin Standard Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Telavancin Standard Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/29 (37.93%)      6/29 (20.69%)    
Cardiac disorders     
Endocarditis bacterial  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Gastrointestinal disorders     
Abdominal Pain  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Nausea  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Vomiting  1  0/29 (0.00%)  0 1/29 (3.45%)  1
General disorders     
Adverse Drug Reaction  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Death  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Multi-organ Failure  1  1/29 (3.45%)  1 1/29 (3.45%)  1
Neuroleptic Malignant Syndrome  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Pyrexia  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Infections and infestations     
Endocarditis  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Lobar Pneumonia  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Sepsis  1  1/29 (3.45%)  1 1/29 (3.45%)  1
Investigations     
Blood creatinine increased  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Metabolism and nutrition disorders     
Dehydration  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/29 (0.00%)  0 1/29 (3.45%)  1
Nervous system disorders     
Neuropathy peripheral  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Syncope vasovagal  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Psychiatric disorders     
Mental Status Changes  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Renal and urinary disorders     
Renal Failure Acute  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Renal Failure Chronic  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Dyspnoea  1  1/29 (3.45%)  1 1/29 (3.45%)  1
Pleural Effusion  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Respiratory Tract Congestion  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Vascular disorders     
Deep Vein Thrombosis  1  1/29 (3.45%)  1 0/29 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Telavancin Standard Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/29 (89.66%)      21/29 (72.41%)    
Blood and lymphatic system disorders     
Anemia  1  3/29 (10.34%)  3 2/29 (6.90%)  2
Eosinophilia  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Gastrointestinal disorders     
Diarrhoea  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Nausea  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Vomiting  1  1/29 (3.45%)  1 2/29 (6.90%)  2
General disorders     
Catheter site erythema  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Pyrexia  1  3/29 (10.34%)  3 2/29 (6.90%)  2
Infections and infestations     
Catheter site infection  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Urinary Tract Infection  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Urinary Tract Infection Fungal  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Investigations     
Blood Urea increased  1  2/29 (6.90%)  2 0/29 (0.00%)  0
Eosinophil Count increased  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Metabolism and nutrition disorders     
Hypokalemia  1  3/29 (10.34%)  3 1/29 (3.45%)  1
Nervous system disorders     
Dysgeusia  1  3/29 (10.34%)  3 0/29 (0.00%)  0
Headache  1  3/29 (10.34%)  3 3/29 (10.34%)  3
Psychiatric disorders     
Agitation  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Insomnia  1  2/29 (6.90%)  2 1/29 (3.45%)  1
Renal and urinary disorders     
Haematuria  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Skin and subcutaneous tissue disorders     
Pruritis  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Rash pruritic  1  0/29 (0.00%)  0 2/29 (6.90%)  2
Vascular disorders     
Deep Vein Thrombosis  1  3/29 (10.34%)  3 1/29 (3.45%)  1
Phlebitis  1  1/29 (3.45%)  1 2/29 (6.90%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance, Inc
Phone: 650-808-6132
Responsible Party: Steven L. Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00062647     History of Changes
Other Study ID Numbers: I6424-203a
First Submitted: June 9, 2003
First Posted: June 12, 2003
Results First Submitted: December 2, 2009
Results First Posted: March 22, 2011
Last Update Posted: January 16, 2019