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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;   Endpoint Classification: Safety/Efficacy Study;   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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
No text entered.

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  
Number of Participants  
[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  
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
Health Authority: United States: Food and Drug Administration