A Study of Ceftobiprole in Patients With Fever and Neutropenia.

This study has been terminated.

(Study discontinued due to administrative reasons unrelated to safety)

Sponsor:

Information provided by (Responsible Party):

Basilea Pharmaceutica

ClinicalTrials.gov Identifier:

NCT00529282

First received: September 11, 2007

Last updated: July 26, 2012

Last verified: July 2012

History of Changes

Results First Received: January 26, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Fever Neutropenia Gram-positive Bacterial Infections Pseudomonas Infection
Interventions:	Drug: Ceftobiprole Medocaril Drug: Cefepime with or without vancomycin

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
No text entered.

Reporting Groups

	Description
Ceftobiprole Medocaril	500 mg every 8 hours - 120-minute infusion [250 mL]
Cefepime With or Without Vancomycin	2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion

Participant Flow: Overall Study

	Ceftobiprole Medocaril	Cefepime With or Without Vancomycin
STARTED	0	2
COMPLETED	0	2
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Ceftobiprole Medocaril	500 mg every 8 hours - 120-minute infusion [250 mL]
Cefepime With or Without Vancomycin	2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
Total	Total of all reporting groups

Baseline Measures

	Ceftobiprole Medocaril	Cefepime With or Without Vancomycin	Total
Number of Participants [units: participants]	0	2	2
Age [units: participants]
<=18 years		0	0
Between 18 and 65 years		2	2
>=65 years		0	0
Gender [units: participants]
Female		1	1
Male		1	1
Region of Enrollment [units: participants]
United States		2	2

Outcome Measures

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1. Primary:

Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia. [ Time Frame: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. ]

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2. Secondary:

Clinical Cure Regardless of Modification of Therapy [ Time Frame: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. ]

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3. Secondary:

Clinical Success at 72 Hours [ Time Frame: 72 hours after starting study drug ]

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4. Secondary:

Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug [ Time Frame: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. ]

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Serious Adverse Events

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Time Frame	The first subject completed on day 41 and the second subject completed on day 56.
Additional Description	No text entered.

Reporting Groups

	Description
Ceftobiprole Medocaril	500 mg every 8 hours - 120-minute infusion [250 mL]
Cefepime With or Without Vancomycin	2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion

Serious Adverse Events

	Ceftobiprole Medocaril	Cefepime With or Without Vancomycin
Total, serious adverse events
# participants affected / at risk	0/0 (0.00%)	2/2 (100.00%)
Infections and infestations
Bacteraemia ^{* 1}
# participants affected / at risk	0/0 (0.00%)	1/2 (50.00%)
Sepsis ^{* 1}
# participants affected / at risk	0/0 (0.00%)	1/2 (50.00%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (12.0)

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 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI 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
No analysis was performed due to early termination of the study.

Results Point of Contact:

Name/Title: Clincal Team Lead
Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
phone: 908 927-3785

No publications provided

Responsible Party:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00529282 History of Changes
Other Study ID Numbers:	CR014206, CEFTOFBN3004
Study First Received:	September 11, 2007
Results First Received:	January 26, 2010
Last Updated:	July 26, 2012
Health Authority:	United States: Food and Drug Administration

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