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

History of Changes

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

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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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

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