Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00335478
First received: June 8, 2006
Last updated: May 24, 2012
Last verified: July 2011
Results First Received: June 7, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Fever
Sweating
Hot Flashes
Infection
Neutropenia
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
  Description
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
    Daptomycin  
STARTED     54  
COMPLETED     30  
NOT COMPLETED     24  



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

Baseline Measures
    Daptomycin  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     6  
Age  
[units: years]
Median ± Standard Deviation
  50.4  ± 16.730  
Gender  
[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
e-mail: bubaloj@ohsu.edu


No publications provided


Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00335478     History of Changes
Other Study ID Numbers: CDR0000476568, OHSU-CPC-05052-L, OHSU-1321, CUBIST-OHSU-CPC-05052-L
Study First Received: June 8, 2006
Results First Received: June 7, 2011
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration