Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 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) (FAST2)

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: NCT00077675
Recruitment Status : Completed
First Posted : February 13, 2004
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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Infections, Gram-positive Bacterial
Interventions Drug: Telavancin
Drug: vancomycin or antistaphylococcal penicillin
Enrollment 201
Recruitment Details Enrollment Period: 20Feb2004 to 09SEP2004
Pre-assignment Details  
Arm/Group Title Telavancin Standard of Care for cSSSI
Hide Arm/Group Description Telavancin 10 mg/kg every 24 hours intravenously Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
Period Title: Overall Study
Started 103 98
Completed 92 89
Not Completed 11 9
Reason Not Completed
Adverse Event             1             2
Lost to Follow-up             6             3
Withdrawal by Subject             1             0
Other             0             1
Never received study treatment             3             3
Arm/Group Title Telavancin Standard of Care for cSSSI Total
Hide Arm/Group Description Telavancin 10 mg/kg every 24 hours intravenously Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously] Total of all reporting groups
Overall Number of Baseline Participants 100 95 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 95 participants 195 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
92
  92.0%
91
  95.8%
183
  93.8%
>=65 years
8
   8.0%
4
   4.2%
12
   6.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 95 participants 195 participants
44.7  (13.7) 42.3  (10.8) 43.6  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 95 participants 195 participants
Female
45
  45.0%
33
  34.7%
78
  40.0%
Male
55
  55.0%
62
  65.3%
117
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 95 participants 195 participants
Hispanic or Latino
14
  14.0%
17
  17.9%
31
  15.9%
Not Hispanic or Latino
86
  86.0%
78
  82.1%
164
  84.1%
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 100 participants 95 participants 195 participants
American Indian or Alaska Native
1
   1.0%
0
   0.0%
1
   0.5%
Asian
2
   2.0%
2
   2.1%
4
   2.1%
Native Hawaiian or Other Pacific Islander
3
   3.0%
1
   1.1%
4
   2.1%
Black or African American
29
  29.0%
30
  31.6%
59
  30.3%
White
41
  41.0%
43
  45.3%
84
  43.1%
More than one race
24
  24.0%
19
  20.0%
43
  22.1%
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 100 participants 95 participants 195 participants
United States 58 54 112
South Africa 42 41 83
Diabetes Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 95 participants 195 participants
Diabetic 18 14 32
Not Diabetic 82 81 163
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 Test-of-Cure (TOC) visit
  • Indeterminate: Inability to determine outcome.
Time Frame 7 to 14 days following completion of antibiotic treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The CE population was 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:
Telavancin 10 mg/kg every 24 hours intravenously
Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
Overall Number of Participants Analyzed 77 77
Measure Type: Number
Unit of Measure: participants
Cured 74 72
Failure 3 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Telavancin, Standard of Care for cSSSI
Comments 95% Confidence Interval: -0.0527 to 0.1102 No estimated 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 91% power to test telavancin's non-inferiority to vancomycin with respect to clinical response using a non-inferiority margin of 20%
Statistical Test of Hypothesis P-Value 0.5318
Comments [Not Specified]
Method 2-sided 95% confidence interval calculat
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 Telavancin 10 mg/kg every 24 hours intravenously Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
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   7/100 (7.00%)   3/95 (3.16%) 
Blood and lymphatic system disorders     
Disseminated Intravascular Coagulation   1/100 (1.00%)  0/95 (0.00%) 
Thrombocytopenia   1/100 (1.00%)  0/95 (0.00%) 
Cardiac disorders     
Atrial fibrillation   1/100 (1.00%)  0/95 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Haemorrhage   1/100 (1.00%)  0/95 (0.00%) 
General disorders     
Multi-organ Failure   0/100 (0.00%)  1/95 (1.05%) 
Hepatobiliary disorders     
Hepatic Failure   0/100 (0.00%)  1/95 (1.05%) 
Infections and infestations     
Lobar Pneumonia   1/100 (1.00%)  0/95 (0.00%) 
Subcutaneous Abscess   1/100 (1.00%)  0/95 (0.00%) 
Wound Infection   1/100 (1.00%)  0/95 (0.00%) 
Sepsis   0/100 (0.00%)  1/95 (1.05%) 
Bacteraemia   0/100 (0.00%)  1/95 (1.05%) 
Musculoskeletal and connective tissue disorders     
Myositis   1/100 (1.00%)  0/95 (0.00%) 
Psychiatric disorders     
Suicidal Ideation   1/100 (1.00%)  0/95 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute   1/100 (1.00%)  1/95 (1.05%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure   0/100 (0.00%)  1/95 (1.05%) 
Atelectasis   0/100 (0.00%)  1/95 (1.05%) 
Lung Infiltration   0/100 (0.00%)  1/95 (1.05%) 
Surgical and medical procedures     
Ileostomy   1/100 (1.00%)  0/95 (0.00%) 
Vascular disorders     
Hypotension   1/100 (1.00%)  0/95 (0.00%) 
Wound Haemorrhage   1/100 (1.00%)  0/95 (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   56/100 (56.00%)   54/95 (56.84%) 
Blood and lymphatic system disorders     
Anemia   3/100 (3.00%)  4/95 (4.21%) 
Disseminated Intravascular Coagulation   1/100 (1.00%)  0/95 (0.00%) 
Leukocytosis   0/100 (0.00%)  1/95 (1.05%) 
Pancytopenia   1/100 (1.00%)  0/95 (0.00%) 
Thrombocythaemia   0/100 (0.00%)  1/95 (1.05%) 
Thrombocytopenia   3/100 (3.00%)  0/95 (0.00%) 
Cardiac disorders     
Atrial fibrillation   1/100 (1.00%)  0/95 (0.00%) 
Cardiac failure   1/100 (1.00%)  0/95 (0.00%) 
Cardiac failure congestive   1/100 (1.00%)  0/95 (0.00%) 
Cyanosis   1/100 (1.00%)  0/95 (0.00%) 
Palpitations   1/100 (1.00%)  0/95 (0.00%) 
Sinus bradycardia   0/100 (0.00%)  1/95 (1.05%) 
Tachycardia   1/100 (1.00%)  0/95 (0.00%) 
Endocrine disorders     
Hyperthyroidism   1/100 (1.00%)  0/95 (0.00%) 
Eye disorders     
Eye Irritation   1/100 (1.00%)  0/95 (0.00%) 
Eye Swelling   1/100 (1.00%)  0/95 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper   0/100 (0.00%)  3/95 (3.16%) 
Constipation   5/100 (5.00%)  7/95 (7.37%) 
Diarrhoea   6/100 (6.00%)  5/95 (5.26%) 
Dry Mouth   1/100 (1.00%)  0/95 (0.00%) 
Dyspepsia   0/100 (0.00%)  2/95 (2.11%) 
Gastrointestinal Haemorrhage   2/100 (2.00%)  0/95 (0.00%) 
Haemorrhoids   1/100 (1.00%)  0/95 (0.00%) 
Hiatus Hernia   0/100 (0.00%)  1/95 (1.05%) 
Nausea   16/100 (16.00%)  6/95 (6.32%) 
Oesophagitis   0/100 (0.00%)  1/95 (1.05%) 
Stomatitis   0/100 (0.00%)  1/95 (1.05%) 
Vomiting   8/100 (8.00%)  6/95 (6.32%) 
General disorders     
Application Site Erythema *  0/100 (0.00%)  1/95 (1.05%) 
Application Site Pruritus *  0/100 (0.00%)  1/95 (1.05%) 
Catheter Site Inflammation *  0/100 (0.00%)  1/95 (1.05%) 
Chest Pain   1/100 (1.00%)  2/95 (2.11%) 
Chills   6/100 (6.00%)  2/95 (2.11%) 
Drug Withdrawal Syndrome   1/100 (1.00%)  0/95 (0.00%) 
Fatigue   1/100 (1.00%)  0/95 (0.00%) 
Infusion site bruising *  1/100 (1.00%)  0/95 (0.00%) 
Infusion site burning *  2/100 (2.00%)  1/95 (1.05%) 
Infusion site erythema *  1/100 (1.00%)  3/95 (3.16%) 
Infusion site induration *  1/100 (1.00%)  0/95 (0.00%) 
Infusion site pain *  1/100 (1.00%)  0/95 (0.00%) 
Infusion site phlebitis *  1/100 (1.00%)  0/95 (0.00%) 
Infusion site rash *  0/100 (0.00%)  1/95 (1.05%) 
Infusion site swelling *  1/100 (1.00%)  0/95 (0.00%) 
Multi-organ Failure   0/100 (0.00%)  1/95 (1.05%) 
Night sweats   2/100 (2.00%)  0/95 (0.00%) 
Oedema Peripheral   1/100 (1.00%)  0/95 (0.00%) 
Pyrexia   2/100 (2.00%)  4/95 (4.21%) 
Hepatobiliary disorders     
Hepatic Failure   0/100 (0.00%)  1/95 (1.05%) 
Infections and infestations     
Abscess   1/100 (1.00%)  0/95 (0.00%) 
Acarodermatitis   1/100 (1.00%)  0/95 (0.00%) 
Bacteraemia   0/100 (0.00%)  1/95 (1.05%) 
Candidiasis   1/100 (1.00%)  0/95 (0.00%) 
Central Line Infection   0/100 (0.00%)  2/95 (2.11%) 
Cystitis   1/100 (1.00%)  0/95 (0.00%) 
Fungal Infection   1/100 (1.00%)  2/95 (2.11%) 
Fungal skin infection   1/100 (1.00%)  0/95 (0.00%) 
Herpes Simplex   1/100 (1.00%)  0/95 (0.00%) 
Herpes Zoster   1/100 (1.00%)  0/95 (0.00%) 
HIV Infection   3/100 (3.00%)  0/95 (0.00%) 
Infection   0/100 (0.00%)  1/95 (1.05%) 
Lobar Pneumonia   1/100 (1.00%)  0/95 (0.00%) 
Oral Candidiasis   1/100 (1.00%)  0/95 (0.00%) 
Sepsis   0/100 (0.00%)  1/95 (1.05%) 
Septic Shock   1/100 (1.00%)  0/95 (0.00%) 
Subcutaneous Abscess   1/100 (1.00%)  1/95 (1.05%) 
Tinea Infection   0/100 (0.00%)  1/95 (1.05%) 
Tuberculosis   1/100 (1.00%)  0/95 (0.00%) 
Urinary Tract Infection   1/100 (1.00%)  2/95 (2.11%) 
Urinary Tract Infection Fungal   1/100 (1.00%)  0/95 (0.00%) 
Vaginal mycosis   1/100 (1.00%)  1/95 (1.05%) 
Wound Infection   1/100 (1.00%)  2/95 (2.11%) 
Injury, poisoning and procedural complications     
Limb Injury *  1/100 (1.00%)  0/95 (0.00%) 
Investigations     
Activated Partial Thromboplastin Time   0/100 (0.00%)  1/95 (1.05%) 
Alanine Aminotransferase increased   3/100 (3.00%)  1/95 (1.05%) 
Albumin Urine Present   3/100 (3.00%)  0/95 (0.00%) 
Aspartate Aminotransferase increased   3/100 (3.00%)  1/95 (1.05%) 
Bacteria Urine   0/100 (0.00%)  1/95 (1.05%) 
Blood Alkaline Phosphatase Increased   1/100 (1.00%)  3/95 (3.16%) 
Blood Bilirubin Increased   0/100 (0.00%)  1/95 (1.05%) 
Blood Creatinine Increased   3/100 (3.00%)  1/95 (1.05%) 
Blood Glucose increased   1/100 (1.00%)  0/95 (0.00%) 
Blood Lactate Dehydrogenase Increased   1/100 (1.00%)  3/95 (3.16%) 
Blood Magnesium decreased   1/100 (1.00%)  0/95 (0.00%) 
Blood Urea increased   1/100 (1.00%)  0/95 (0.00%) 
Eosinophil Count increased   0/100 (0.00%)  2/95 (2.11%) 
Gamma-glutamyltransferase increased   2/100 (2.00%)  5/95 (5.26%) 
Hepatic Enzyme increased   0/100 (0.00%)  9/95 (9.47%) 
Liver function test abnormal   0/100 (0.00%)  2/95 (2.11%) 
Nitrite Urine present   0/100 (0.00%)  1/95 (1.05%) 
Platelet count increased   2/100 (2.00%)  0/95 (0.00%) 
Prothrombin time prolonged   1/100 (1.00%)  1/95 (1.05%) 
QRS axis abnormal   0/100 (0.00%)  1/95 (1.05%) 
Respiratory rate increased   1/100 (1.00%)  0/95 (0.00%) 
Urinary casts   2/100 (2.00%)  0/95 (0.00%) 
Urine analysis abnormal   3/100 (3.00%)  0/95 (0.00%) 
White Blood Cell Count decreased   0/100 (0.00%)  1/95 (1.05%) 
White Blood Cell Count increased   0/100 (0.00%)  1/95 (1.05%) 
Hyperkalaemia   1/100 (1.00%)  0/95 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite   2/100 (2.00%)  0/95 (0.00%) 
Hyperglycemia   1/100 (1.00%)  0/95 (0.00%) 
Hypokalaemia   1/100 (1.00%)  4/95 (4.21%) 
Hypomagnesaemia   5/100 (5.00%)  6/95 (6.32%) 
Polydipsia   1/100 (1.00%)  0/95 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   1/100 (1.00%)  0/95 (0.00%) 
Muscle Spasms   1/100 (1.00%)  0/95 (0.00%) 
Musculoskeletal Discomfort   0/100 (0.00%)  1/95 (1.05%) 
Myalgia   0/100 (0.00%)  1/95 (1.05%) 
Myositis   1/100 (1.00%)  0/95 (0.00%) 
Pain in Extremity   3/100 (3.00%)  2/95 (2.11%) 
Pain in Jaw   0/100 (0.00%)  1/95 (1.05%) 
Nervous system disorders     
Ageusia   1/100 (1.00%)  0/95 (0.00%) 
Depressed Level of Consciousness   1/100 (1.00%)  0/95 (0.00%) 
Dizziness   3/100 (3.00%)  2/95 (2.11%) 
Dizziness Postural   0/100 (0.00%)  1/95 (1.05%) 
Dysgeusia   14/100 (14.00%)  0/95 (0.00%) 
Headache   8/100 (8.00%)  4/95 (4.21%) 
Hypoaesthesia   0/100 (0.00%)  1/95 (1.05%) 
Lethargy   1/100 (1.00%)  1/95 (1.05%) 
Paraesthesia oral   1/100 (1.00%)  0/95 (0.00%) 
Tremor   0/100 (0.00%)  1/95 (1.05%) 
Psychiatric disorders     
Affect Lability   1/100 (1.00%)  0/95 (0.00%) 
Agitation   1/100 (1.00%)  1/95 (1.05%) 
Anxiety   1/100 (1.00%)  0/95 (0.00%) 
Confusional State   1/100 (1.00%)  0/95 (0.00%) 
Depression   0/100 (0.00%)  1/95 (1.05%) 
Hallucination   1/100 (1.00%)  0/95 (0.00%) 
Insomnia   13/100 (13.00%)  3/95 (3.16%) 
Suicidal Ideation   2/100 (2.00%)  0/95 (0.00%) 
Renal and urinary disorders     
Dysuria   0/100 (0.00%)  1/95 (1.05%) 
Haematuria   4/100 (4.00%)  2/95 (2.11%) 
Microalbuminuria   3/100 (3.00%)  5/95 (5.26%) 
Pyuria   0/100 (0.00%)  1/95 (1.05%) 
Renal Failure   1/100 (1.00%)  0/95 (0.00%) 
Renal Failure Acute   1/100 (1.00%)  1/95 (1.05%) 
Renal Impairment   1/100 (1.00%)  0/95 (0.00%) 
Urinary Incontinence   1/100 (1.00%)  0/95 (0.00%) 
Reproductive system and breast disorders     
Genital Burning Sensation   1/100 (1.00%)  0/95 (0.00%) 
Genital Pruritis Female   0/100 (0.00%)  1/95 (1.05%) 
Respiratory, thoracic and mediastinal disorders     
Asthma   1/100 (1.00%)  1/95 (1.05%) 
Atelectasis   0/100 (0.00%)  1/95 (1.05%) 
Cough   2/100 (2.00%)  1/95 (1.05%) 
Crackles Lung   0/100 (0.00%)  1/95 (1.05%) 
Dyspnoea   2/100 (2.00%)  0/95 (0.00%) 
Epistaxis   2/100 (2.00%)  0/95 (0.00%) 
Hypoxia   0/100 (0.00%)  1/95 (1.05%) 
Lung Infiltration   0/100 (0.00%)  1/95 (1.05%) 
Pharyngolaryngeal Pain   1/100 (1.00%)  0/95 (0.00%) 
Respiratory Failure   0/100 (0.00%)  1/95 (1.05%) 
Wheezing   1/100 (1.00%)  0/95 (0.00%) 
Skin and subcutaneous tissue disorders     
Erythema   1/100 (1.00%)  0/95 (0.00%) 
Hyperhidrosis   1/100 (1.00%)  0/95 (0.00%) 
Pruritis   6/100 (6.00%)  8/95 (8.42%) 
Rash   2/100 (2.00%)  0/95 (0.00%) 
Urticaria   1/100 (1.00%)  1/95 (1.05%) 
Surgical and medical procedures     
Ileostomy   1/100 (1.00%)  0/95 (0.00%) 
Intubation   1/100 (1.00%)  0/95 (0.00%) 
Vascular disorders     
Flushing   0/100 (0.00%)  1/95 (1.05%) 
Hot Flush   0/100 (0.00%)  1/95 (1.05%) 
Hypertension   4/100 (4.00%)  1/95 (1.05%) 
Hypotension   2/100 (2.00%)  0/95 (0.00%) 
Hypovolaemic shock   0/100 (0.00%)  1/95 (1.05%) 
Phlebitis   1/100 (1.00%)  1/95 (1.05%) 
Thrombophlebitis   0/100 (0.00%)  2/95 (2.11%) 
Wound Haemorrhage   1/100 (1.00%)  0/95 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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: NCT00077675     History of Changes
Other Study ID Numbers: I6424-202b
First Submitted: February 10, 2004
First Posted: February 13, 2004
Results First Submitted: December 2, 2009
Results First Posted: January 11, 2010
Last Update Posted: January 16, 2019