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Trial record 7 of 8 for:    NAFCILLIN AND cloxacillin

Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) (FAST)

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: NCT00061633
Recruitment Status : Completed
First Posted : June 2, 2003
Results First Posted : January 11, 2010
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
Conditions Infections, Gram-Positive Bacterial
Abscess
Burns
Cellulitis
Ulcer
Wound Infections
Interventions Drug: Telavancin
Drug: Vancomycin or antistaphylococcal penicillin
Enrollment 169
Recruitment Details Enrollment Period: 05Jun03 to 20Jan04
Pre-assignment Details  
Arm/Group Title Telavancin Standard of Care for cSSSI
Hide Arm/Group Description Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
Period Title: Overall Study
Started 84 85
Completed 79 74
Not Completed 5 11
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             2             2
Lost to Follow-up             1             4
Other             1             1
Never received study treatment             0             2
Arm/Group Title Telavancin Standard of Care for cSSSI Total
Hide Arm/Group Description Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin. Total of all reporting groups
Overall Number of Baseline Participants 84 83 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
80
  95.2%
78
  94.0%
158
  94.6%
>=65 years
4
   4.8%
5
   6.0%
9
   5.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 84 participants 83 participants 167 participants
44.6  (13.9) 44.3  (13.5) 44.4  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
Female
30
  35.7%
37
  44.6%
67
  40.1%
Male
54
  64.3%
46
  55.4%
100
  59.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
Hispanic or Latino
15
  17.9%
10
  12.0%
25
  15.0%
Not Hispanic or Latino
68
  81.0%
72
  86.7%
140
  83.8%
Unknown or Not Reported
1
   1.2%
1
   1.2%
2
   1.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
American Indian or Alaska Native
0
   0.0%
1
   1.2%
1
   0.6%
Asian
4
   4.8%
1
   1.2%
5
   3.0%
Native Hawaiian or Other Pacific Islander
6
   7.1%
5
   6.0%
11
   6.6%
Black or African American
21
  25.0%
20
  24.1%
41
  24.6%
White
38
  45.2%
41
  49.4%
79
  47.3%
More than one race
13
  15.5%
14
  16.9%
27
  16.2%
Unknown or Not Reported
2
   2.4%
1
   1.2%
3
   1.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
United States 59 58 117
South Africa 25 25 50
Diabetes Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
Diabetic 25 19 44
Non-Diabetic 59 64 123
1.Primary Outcome
Title Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population
Hide Description
  • Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.
  • Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit.
  • Indeterminate: Inability to determine outcome.
Time Frame 7-14 days following end of antibiotic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure." The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population.
Arm/Group Title Telavancin Standard of Care for cSSSI
Hide Arm/Group Description:
Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
Overall Number of Participants Analyzed 72 69
Measure Type: Number
Unit of Measure: participants
Cured 66 66
Failure 6 3
Indeterminate 0 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telavancin, Standard of Care for cSSSI
Comments 95% Confidence Interval: -0.1349 to 0.0485 No est. value. Parameter that was estimated: Risk Difference
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size was selected on the basis of clinical judgment and was deemed adequate to provide clinically meaningful descriptive results consistent with study objectives. This sample size was estimated to provide 39% power to test televancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 10%.
Statistical Test of Hypothesis P-Value 0.5289
Comments [Not Specified]
Method 2-sided 95% confidence interval
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Population was the "All Treated Population" - all patients who received one treatment. The Primary Analysis was of the Clinically Evaluable (CE) Population. The CE population was composed of the patients who met the inclusion / exclusion criteria or were granted permission to enroll and had a clinical response of "cure" or "failure".
 
Arm/Group Title Telavancin Standard of Care for cSSSI
Hide Arm/Group Description Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously) Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
All-Cause Mortality
Telavancin Standard of Care for cSSSI
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Telavancin Standard of Care for cSSSI
Affected / at Risk (%) Affected / at Risk (%)
Total   3/84 (3.57%)   9/83 (10.84%) 
Infections and infestations     
Cellulitis   0/84 (0.00%)  3/83 (3.61%) 
Necrotizing Fasciitis   1/84 (1.19%)  0/83 (0.00%) 
Subcutaneous Abscess   0/84 (0.00%)  1/83 (1.20%) 
Wound Abscess   0/84 (0.00%)  1/83 (1.20%) 
Wound Infection   1/84 (1.19%)  0/83 (0.00%) 
Injury, poisoning and procedural complications     
Wound dehiscence   0/84 (0.00%)  1/83 (1.20%) 
Musculoskeletal and connective tissue disorders     
Inguinal mass   0/84 (0.00%)  1/83 (1.20%) 
Reproductive system and breast disorders     
Vaginal Haemorrhage   0/84 (0.00%)  1/83 (1.20%) 
Skin and subcutaneous tissue disorders     
Angioneurotic Oedema   0/84 (0.00%)  1/83 (1.20%) 
Vascular disorders     
Gangrene   1/84 (1.19%)  0/83 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Telavancin Standard of Care for cSSSI
Affected / at Risk (%) Affected / at Risk (%)
Total   46/84 (54.76%)   50/83 (60.24%) 
Blood and lymphatic system disorders     
Anemia   2/84 (2.38%)  1/83 (1.20%) 
Leukopenia   1/84 (1.19%)  0/83 (0.00%) 
Cardiac disorders     
Arrhythmia   1/84 (1.19%)  0/83 (0.00%) 
Atrial fibrillation   0/84 (0.00%)  1/83 (1.20%) 
Eye disorders     
Keratoconjunctivitis Sicca   1/84 (1.19%)  0/83 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain   2/84 (2.38%)  1/83 (1.20%) 
Abdominal pain upper   0/84 (0.00%)  2/83 (2.41%) 
Constipation   3/84 (3.57%)  5/83 (6.02%) 
Diarrhoea   1/84 (1.19%)  2/83 (2.41%) 
Dry Mouth   1/84 (1.19%)  0/83 (0.00%) 
Dyspepsia   2/84 (2.38%)  0/83 (0.00%) 
Dysphasia   0/84 (0.00%)  1/83 (1.20%) 
Nausea   13/84 (15.48%)  11/83 (13.25%) 
Post-Procedural Nausea   0/84 (0.00%)  1/83 (1.20%) 
Retching   0/84 (0.00%)  1/83 (1.20%) 
Toothache   2/84 (2.38%)  0/83 (0.00%) 
Vomiting   8/84 (9.52%)  3/83 (3.61%) 
General disorders     
Anasarca   1/84 (1.19%)  0/83 (0.00%) 
Catheter related complication   0/84 (0.00%)  1/83 (1.20%) 
Catheter Site Inflammation   1/84 (1.19%)  0/83 (0.00%) 
Catheter site rash   0/84 (0.00%)  1/83 (1.20%) 
Chest Pain   0/84 (0.00%)  1/83 (1.20%) 
Discomfort   1/84 (1.19%)  1/83 (1.20%) 
Drug Withdrawal Syndrome   1/84 (1.19%)  1/83 (1.20%) 
Fatigue   2/84 (2.38%)  0/83 (0.00%) 
Feeling hot   2/84 (2.38%)  1/83 (1.20%) 
Feeling jittery   0/84 (0.00%)  1/83 (1.20%) 
Infusion site pain   1/84 (1.19%)  1/83 (1.20%) 
Injection Site Extravasation   0/84 (0.00%)  1/83 (1.20%) 
Injection site phlebitis   0/84 (0.00%)  1/83 (1.20%) 
Oedema Peripheral   1/84 (1.19%)  1/83 (1.20%) 
Pain   1/84 (1.19%)  0/83 (0.00%) 
Pain exacerbated   1/84 (1.19%)  0/83 (0.00%) 
Pyrexia   3/84 (3.57%)  1/83 (1.20%) 
Red Man Syndrome   0/84 (0.00%)  3/83 (3.61%) 
Rigors   1/84 (1.19%)  1/83 (1.20%) 
Infections and infestations     
Abscess   1/84 (1.19%)  0/83 (0.00%) 
Bacteriuria   3/84 (3.57%)  0/83 (0.00%) 
Cellulitis   0/84 (0.00%)  3/83 (3.61%) 
Gonorrhea   1/84 (1.19%)  0/83 (0.00%) 
Influenza   1/84 (1.19%)  1/83 (1.20%) 
Localized Infection   1/84 (1.19%)  0/83 (0.00%) 
Nasal abscess   0/84 (0.00%)  1/83 (1.20%) 
Necrotizing Fasciitis   1/84 (1.19%)  0/83 (0.00%) 
Subcutaneous Abscess   0/84 (0.00%)  1/83 (1.20%) 
Superinfection   1/84 (1.19%)  1/83 (1.20%) 
Tuberculosis   1/84 (1.19%)  0/83 (0.00%) 
Upper Respiratory Infection   0/84 (0.00%)  1/83 (1.20%) 
Urinary Tract Infection   4/84 (4.76%)  4/83 (4.82%) 
Vaginal Candidiasis   1/84 (1.19%)  0/83 (0.00%) 
Wound Abscess   0/84 (0.00%)  1/83 (1.20%) 
Wound infection staphylococcal   1/84 (1.19%)  0/83 (0.00%) 
Injury, poisoning and procedural complications     
Tinea Pedis   0/84 (0.00%)  1/83 (1.20%) 
Blister   1/84 (1.19%)  0/83 (0.00%) 
Ligament Injury   1/84 (1.19%)  0/83 (0.00%) 
Muscle Strain   0/84 (0.00%)  1/83 (1.20%) 
Wound dehiscence   0/84 (0.00%)  1/83 (1.20%) 
Investigations     
Alanine Aminotransferase increased   0/84 (0.00%)  4/83 (4.82%) 
Aspartate Aminotransferase increased   1/84 (1.19%)  6/83 (7.23%) 
Blood Alkaline phosphatase increased   1/84 (1.19%)  1/83 (1.20%) 
Blood creatinine increased   1/84 (1.19%)  0/83 (0.00%) 
Blood glucose decreased   0/84 (0.00%)  1/83 (1.20%) 
Blood in stool   0/84 (0.00%)  1/83 (1.20%) 
Blood lactate dehydrogenase increased   2/84 (2.38%)  3/83 (3.61%) 
Blood pressure increased   1/84 (1.19%)  0/83 (0.00%) 
Body temperature increased   1/84 (1.19%)  0/83 (0.00%) 
Gamma-glutamyltransferase increased   2/84 (2.38%)  1/83 (1.20%) 
Hepatic Enzyme increased   0/84 (0.00%)  1/83 (1.20%) 
HIV Test positive   1/84 (1.19%)  0/83 (0.00%) 
Liver function test abnormal   1/84 (1.19%)  1/83 (1.20%) 
Metabolism and nutrition disorders     
Anorexia   0/84 (0.00%)  3/83 (3.61%) 
Diabetes Mellitus   1/84 (1.19%)  0/83 (0.00%) 
Hyperglycaemia   0/84 (0.00%)  2/83 (2.41%) 
Hypoglycaemia   1/84 (1.19%)  0/83 (0.00%) 
Hypokalaemia   3/84 (3.57%)  0/83 (0.00%) 
Hypomagnesaemia   2/84 (2.38%)  3/83 (3.61%) 
Hyponatremia   0/84 (0.00%)  1/83 (1.20%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   1/84 (1.19%)  0/83 (0.00%) 
Back Pain   1/84 (1.19%)  3/83 (3.61%) 
Inguinal mass   0/84 (0.00%)  1/83 (1.20%) 
Neck Pain   0/84 (0.00%)  1/83 (1.20%) 
Pain in Extremity   0/84 (0.00%)  3/83 (3.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Uterine Leiomyoma   0/84 (0.00%)  1/83 (1.20%) 
Nervous system disorders     
Burning sensation   2/84 (2.38%)  0/83 (0.00%) 
Dizziness   2/84 (2.38%)  1/83 (1.20%) 
Headache   9/84 (10.71%)  8/83 (9.64%) 
Hypoaesthesia   1/84 (1.19%)  0/83 (0.00%) 
Migraine   0/84 (0.00%)  1/83 (1.20%) 
Paraesthesia   3/84 (3.57%)  0/83 (0.00%) 
Somnolence   1/84 (1.19%)  1/83 (1.20%) 
Tremor   1/84 (1.19%)  0/83 (0.00%) 
Psychiatric disorders     
Agitation   2/84 (2.38%)  3/83 (3.61%) 
Anxiety   6/84 (7.14%)  2/83 (2.41%) 
Confusional State   0/84 (0.00%)  1/83 (1.20%) 
Depression   1/84 (1.19%)  1/83 (1.20%) 
Disorientation   0/84 (0.00%)  1/83 (1.20%) 
Euphoric Mood   1/84 (1.19%)  0/83 (0.00%) 
Insomnia   0/84 (0.00%)  4/83 (4.82%) 
Irritability   1/84 (1.19%)  1/83 (1.20%) 
Restlessness   0/84 (0.00%)  1/83 (1.20%) 
Schizophrenia   1/84 (1.19%)  0/83 (0.00%) 
Renal and urinary disorders     
Albuminuria   0/84 (0.00%)  1/83 (1.20%) 
Diabetic neuropathy   0/84 (0.00%)  1/83 (1.20%) 
Haematuria   1/84 (1.19%)  1/83 (1.20%) 
Microalbuminuria   4/84 (4.76%)  1/83 (1.20%) 
Urinary Incontinence   1/84 (1.19%)  1/83 (1.20%) 
Reproductive system and breast disorders     
Genital Pruritis Female   0/84 (0.00%)  1/83 (1.20%) 
Vaginal Haemorrhage   0/84 (0.00%)  1/83 (1.20%) 
Respiratory, thoracic and mediastinal disorders     
Asthma   1/84 (1.19%)  0/83 (0.00%) 
Cough   3/84 (3.57%)  1/83 (1.20%) 
Crackles Lung   2/84 (2.38%)  0/83 (0.00%) 
Dyspnoea   5/84 (5.95%)  1/83 (1.20%) 
Hiccups   1/84 (1.19%)  0/83 (0.00%) 
Rhonchi   1/84 (1.19%)  0/83 (0.00%) 
Wheezing   1/84 (1.19%)  2/83 (2.41%) 
Skin and subcutaneous tissue disorders     
Acne   1/84 (1.19%)  0/83 (0.00%) 
Angioneurotic Oedema   0/84 (0.00%)  1/83 (1.20%) 
Dermatitis contact   0/84 (0.00%)  1/83 (1.20%) 
Dry Skin   0/84 (0.00%)  2/83 (2.41%) 
Erythema   1/84 (1.19%)  0/83 (0.00%) 
Hyperhidrosis   0/84 (0.00%)  1/83 (1.20%) 
Night sweats   1/84 (1.19%)  0/83 (0.00%) 
Photosensitivity Reaction   0/84 (0.00%)  1/83 (1.20%) 
Pruritis   3/84 (3.57%)  1/83 (1.20%) 
Rash   2/84 (2.38%)  2/83 (2.41%) 
Rash pruritic   0/84 (0.00%)  1/83 (1.20%) 
Skin Burning sensation   0/84 (0.00%)  1/83 (1.20%) 
Skin Irritation   0/84 (0.00%)  1/83 (1.20%) 
Skin Ulcer   1/84 (1.19%)  0/83 (0.00%) 
Urticaria   0/84 (0.00%)  1/83 (1.20%) 
Vascular disorders     
Flushing   0/84 (0.00%)  1/83 (1.20%) 
Gangrene   1/84 (1.19%)  0/83 (0.00%) 
Hot Flush   0/84 (0.00%)  1/83 (1.20%) 
Hypertension   1/84 (1.19%)  0/83 (0.00%) 
Hypotension   3/84 (3.57%)  1/83 (1.20%) 
Peripheral Ischaemia   1/84 (1.19%)  0/83 (0.00%) 
Phlebitis   0/84 (0.00%)  1/83 (1.20%) 
Thrombophlebitis   1/84 (1.19%)  2/83 (2.41%) 
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Steve Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Organization: Theravance, Inc
Phone: 650-808-6132
EMail: sbarriere@theravance.com
Layout table for additonal information
Responsible Party: Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs, Theravance, Inc.
ClinicalTrials.gov Identifier: NCT00061633     History of Changes
Other Study ID Numbers: I6424-202a
First Submitted: May 30, 2003
First Posted: June 2, 2003
Results First Submitted: December 2, 2009
Results First Posted: January 11, 2010
Last Update Posted: January 16, 2019