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Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

This study has been completed.
Information provided by (Responsible Party):
OHSU Knight Cancer Institute Identifier:
First received: June 8, 2006
Last updated: October 20, 2015
Last verified: October 2015
Results First Received: June 7, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Fever
Hot Flashes
Unspecified Adult Solid Tumor, Protocol Specific
Intervention: Drug: Daptomycin

  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
Daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.

Participant Flow:   Overall Study

  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
Daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   6 
[Units: Years]
Median (Standard Deviation)
 50.4  (16.730) 
[Units: Participants]
Female   20 
Male   10 
Region of Enrollment 
[Units: Participants]
United States   30 

  Outcome Measures

1.  Primary:   Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.   [ Time Frame: Within 72 hours of starting daptomycin ]

  Serious Adverse Events

  Other Adverse Events

  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 NOT 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:  
Name/Title: Joseph Bubalo, PharmD, BCPS, BCOP
Organization: OHSU Knight Cancer Institute
phone: 503-494-1080

Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00335478     History of Changes
Other Study ID Numbers: CDR0000476568
OHSU-CPC-05052-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-1321 ( Other Identifier: OHSU IRB )
CUBIST-OHSU-CPC-05052-L ( Other Identifier: Cubist Pharmaceuticals )
Study First Received: June 8, 2006
Results First Received: June 7, 2011
Last Updated: October 20, 2015