Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

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. Identifier: NCT00335478
Recruitment Status : Completed
First Posted : June 12, 2006
Results First Posted : August 9, 2011
Last Update Posted : May 9, 2017
Information provided by (Responsible Party):
Joseph Bubalo, OHSU Knight Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions: Fever
Hot Flashes
Unspecified Adult Solid Tumor, Protocol Specific
Intervention: Drug: Daptomycin

  Participant Flow

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

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]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      24  80.0% 
>=65 years      6  20.0% 
[Units: Years]
Median (Standard Deviation)
 50.4  (16.730) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      20  66.7% 
Male      10  33.3% 
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

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

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: Joseph Bubalo, 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 )
First Submitted: June 8, 2006
First Posted: June 12, 2006
Results First Submitted: June 7, 2011
Results First Posted: August 9, 2011
Last Update Posted: May 9, 2017