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Trial record 5 of 19 for:    Infections | Oxacillin

Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections

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ClinicalTrials.gov Identifier: NCT01184872
Recruitment Status : Completed
First Posted : August 19, 2010
Results First Posted : April 18, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infections
Interventions Drug: Daptomycin
Drug: Vancomycin or Semi-Synthetic Penicillins (SSPs)
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
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Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Period Title: Overall Study
Started 81 [1] 39
Safety Set 80 [2] 40
Clinical Evaluable Set (CES) 73 30
Microbiologically Evaluable Set (MES) 65 27
Completed 71 31
Not Completed 10 8
Reason Not Completed
Adverse Event             3             4
Unsatisfactory therapeutic effect             3             2
Withdrawal by Subject             2             0
Lost to Follow-up             0             1
Administrative problems             1             1
Protocol deviation             1             0
[1]
"Started" indicates randomized and full analysis set.
[2]
One patient randomized to Daptomycin received Vancomycin.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs) Total
Hide Arm/Group Description

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Total of all reporting groups
Overall Number of Baseline Participants 81 39 120
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 39 participants 120 participants
74.63  (6.331) 75.28  (5.515) 74.84  (6.063)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 39 participants 120 participants
Female
47
  58.0%
26
  66.7%
73
  60.8%
Male
34
  42.0%
13
  33.3%
47
  39.2%
1.Primary Outcome
Title Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
Hide Description Success: Clinically significant signs and symptoms associated with the skin infection present at the pre-treatment infection site resolved (cure), or improved without need of further antibacterial therapy. Failure: Persistence or progression of signs and symptoms or development of new clinical signs and symptoms at the infection site, or concomitant antibacterial therapy with activity against isolated organisms, or treatment duration longer than pre-specified, or switch back to intravenous therapy due to relapse, or requirement of a major surgical procedure as adjunct or follow-up therapy.
Time Frame Baseline and 7 to 14 days after end of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
The clinically evaluable population was used for the efficacy analysis. It included all patients who met the criteria for complicated skin and soft tissue, had no substantive protocol deviation, had a sponsor clinical response assessment of “success” or “failure” at the assessment visit, and had a specified baseline primary site of infection.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Overall Number of Participants Analyzed 73 30
Measure Type: Number
Unit of Measure: participants
Success 65 25
Failure 8 5
2.Secondary Outcome
Title Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
Hide Description Microbiological Success: All infecting Gram-positive pathogens isolated at baseline were eradicated or presumed to be eradicated at the Test-of-Cure (TOC) evaluation and a super infecting pathogen was not isolated either prior to or at the TOC evaluation. Microbiological Failure: Persistence or relapse / re-infection of one or more infecting Gram-positive pathogens or isolation of a super infecting pathogen prior to or at the TOC evaluation.
Time Frame Baseline and 7 to 14 days after end of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Population analyzed consisted of patients from the clinically evaluable population who had independent microbiological assessments.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Overall Number of Participants Analyzed 65 27
Measure Type: Number
Unit of Measure: participants
Success 54 23
Failure 11 4
3.Secondary Outcome
Title Duration of Treatment (Intravenous)
Hide Description Duration of treatment is the interval from first to last intravenous (i.v.) administration. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) comprised all patients to whom study treatment had been assigned at randomization.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Overall Number of Participants Analyzed 81 39
Mean (Standard Deviation)
Unit of Measure: Days
7.8  (3.42) 7.3  (2.42)
4.Secondary Outcome
Title Duration of Treatment (Intravenous and Oral)
Hide Description Duration of treatment is the interval from first to last intravenous (i.v.) or to last oral administration if patients switched to an oral antibiotic therapy. It was preferable that a patient complete the whole antibiotic treatment with the randomized i.v. study drug only. Duration of treatment in patients with bacteremia could be extended up to 28 days.
Time Frame Up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis set (FAS) comprised all patients to whom study treatment had been assigned at randomization.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Overall Number of Participants Analyzed 81 39
Mean (Standard Deviation)
Unit of Measure: Days
intravenous only 7.8  (3.4) 7.3  (2.4)
intravenous + oral 8.7  (4.9) 9.6  (5.4)
5.Secondary Outcome
Title Number of Patients With Adverse Events, Serious Adverse Events and Death
Hide Description [Not Specified]
Time Frame Continuously from baseline up to 28 days after end of antibiotic treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set included all patients who received at least one dose of study medication and who had at least one post-baseline safety assessment.
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description:

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

Overall Number of Participants Analyzed 80 40
Measure Type: Number
Unit of Measure: participants
Adverse Events 50 26
Serious Adverse Events 7 4
Death 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Hide Arm/Group Description

Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.

Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days.

Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.

Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days.

All-Cause Mortality
Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/80 (8.75%)   4/40 (10.00%) 
Blood and lymphatic system disorders     
Pancytopenia  1  0/80 (0.00%)  1/40 (2.50%) 
General disorders     
Necrosis  1  1/80 (1.25%)  0/40 (0.00%) 
Infections and infestations     
Klebsiella infection  1  1/80 (1.25%)  0/40 (0.00%) 
Pneumonia  1  1/80 (1.25%)  0/40 (0.00%) 
Investigations     
Blood creatine phosphokinase increased  1  1/80 (1.25%)  0/40 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Nasopharyngeal cancer recurrent  1  1/80 (1.25%)  0/40 (0.00%) 
Squamous cell carcinoma  1  1/80 (1.25%)  0/40 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  0/80 (0.00%)  1/40 (2.50%) 
Renal and urinary disorders     
Nephropathy toxic  1  0/80 (0.00%)  1/40 (2.50%) 
Renal failure acute  1  0/80 (0.00%)  1/40 (2.50%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/80 (0.00%)  1/40 (2.50%) 
Pulmonary embolism  1  1/80 (1.25%)  0/40 (0.00%) 
Vascular disorders     
Thrombosis  1  1/80 (1.25%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daptomycin Vancomycin or Semi-Synthetic Penicillins (SSPs)
Affected / at Risk (%) Affected / at Risk (%)
Total   31/80 (38.75%)   14/40 (35.00%) 
Gastrointestinal disorders     
Nausea  1  5/80 (6.25%)  2/40 (5.00%) 
General disorders     
Hyperthermia  1  11/80 (13.75%)  3/40 (7.50%) 
Investigations     
Blood creatine phosphokinase increased  1  5/80 (6.25%)  1/40 (2.50%) 
Blood creatinine increased  1  1/80 (1.25%)  2/40 (5.00%) 
Blood pressure increased  1  5/80 (6.25%)  2/40 (5.00%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/80 (0.00%)  2/40 (5.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/80 (5.00%)  1/40 (2.50%) 
Vascular disorders     
Hypertension  1  6/80 (7.50%)  5/40 (12.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceutical
Phone: 862 778 8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01184872     History of Changes
Other Study ID Numbers: CCBC134A2404
2009-014391-22 ( EudraCT Number )
First Submitted: February 18, 2010
First Posted: August 19, 2010
Results First Submitted: March 22, 2012
Results First Posted: April 18, 2012
Last Update Posted: July 13, 2012