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Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00428844
First received: January 26, 2007
Last updated: January 5, 2016
Last verified: January 2016
History of Changes
Results First Received: March 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteomyelitis
Interventions: Drug: daptomycin
Drug: vancomycin
Drug: teicoplanin
Drug: nafcillin
Drug: oxacillin
Drug: flucloxacillin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Daptomycin 6 mg/kg Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
Daptomycin 8 mg/kg Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
Comparator Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).

Participant Flow for 2 periods

 Period 1:   Completed Study Drug Treatment
    Daptomycin 6 mg/kg   Daptomycin 8 mg/kg   Comparator
STARTED   25   24   26 
Received First Dose   25   24   25 
COMPLETED   23   18   19 
NOT COMPLETED   2   6   7 
Adverse Event                2                4                4 
Protocol Violation                0                1                1 
Withdrawal by Subject                0                1                1 
Randomized Not Treated                0                0                1 

Period 2:   Completed Test of Cure (TOC) Visit
    Daptomycin 6 mg/kg   Daptomycin 8 mg/kg   Comparator
STARTED   23   18   19 
COMPLETED   20   16   17 
NOT COMPLETED   3   2   2 
Adverse Event                0                1                1 
Protocol Violation                0                0                1 
Withdrawal by Subject                1                0                0 
Lack of Efficacy                2                0                0 
Microbiologic failure                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Daptomycin 6 mg/kg Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
Daptomycin 8 mg/kg Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
Comparator Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
Total Total of all reporting groups

Baseline Measures
   Daptomycin 6 mg/kg   Daptomycin 8 mg/kg   Comparator   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 25   24   25   74 
Age [1] 
[Units: Participants]
 		       
<=18 years   0   0   0   0 
Between 18 and 65 years   10   14   15   39 
>=65 years   15   10   10   35 
[1] Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated)
Gender [1] 
[Units: Participants]
 		       
Female   14   10   11   35 
Male   11   14   14   39 
[1] Safety/Intent to Treat Population (1 patient included in the Overall Number of Baseline Participants was randomized to comparator but not treated)


  Outcome Measures
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1.  Primary:   Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)   [ Time Frame: From the 3rd day of therapy to 1 week post last dose (approximately week 7) ]
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2.  Secondary:   Safety - Notable Laboratory Abnormalities   [ Time Frame: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30) ]
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3.  Secondary:   Overall Clinical Outcome   [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]
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4.  Secondary:   Microbiological Response   [ Time Frame: Approximately 6 weeks post last dose (approximately week 12) ]
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5.  Secondary:   Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)   [ Time Frame: Day 4 (steady state) ]
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6.  Secondary:   Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)   [ Time Frame: Day 4 (steady state) ]
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  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ed Campanaro, VP Clinical Operations
Organization: Cubist Pharmaceuticals, Inc.
phone: 781-860-8318
e-mail: ed.campanaro@cubist.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00428844     History of Changes
Other Study ID Numbers: 3009-016
DAP-OST-06-02 ( Other Identifier: Cubist Study Number )
Study First Received: January 26, 2007
Results First Received: March 16, 2011
Last Updated: January 5, 2016