Trial Outcomes & Findings for A Study of Ceftobiprole in Patients With Fever and Neutropenia. (NCT NCT00529282)

Last Updated: 2012-08-01

Results Overview

Clinical cure rate (the ratio of the number of clinically cured patients to the total number of patients in the population) at 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter. Cure without modification: A subject will be considered to be cured at the primary efficacy visit if: The subject's fever and clinical signs and symptoms are resolved to the extent that no further anti-infective therapy is necessary as determined by the investigator Any infecting organisms that were identified at baseline were eradicated

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

2 participants

Primary outcome timeframe

7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.

Results posted on

2012-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Ceftobiprole in Patients With Fever and Neutropenia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftobiprole Medocaril 500 mg every 8 hours - 120-minute infusion \[250 mL\]	Cefepime With or Without Vancomycin n=2 Participants 2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion	Total n=2 Participants Total of all reporting groups
Age Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	—	2 participants n=7 Participants	2 participants n=5 Participants
Age Categorical >=65 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.

Population: No outcome measures were analyzed due to early termination of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.

Population: No outcome measures were analyzed due to early termination of the study.

To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin with regard to clinical cure at the primary efficacy visit after completing the initial course of therapy, regardless of modification of therapy defined as addition of an anti-fungal agent and/or an aminoglycoside. Cure with modification: The subject requires antifungals, which will be considered a failure for the primary endpoint. The subject needs modification of study therapy by adding one or more agents (other than protocol-defined chemoprophylaxis antibiotics).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hours after starting study drug

Population: No outcome measures were analyzed due to early termination of the study.

To compare the clinical success rate (absence or improvement of signs and symptoms of infection) at 72 hours after starting ceftobiprole with that of cefepime with or without vancomycin

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.

Population: No outcome measures were analyzed due to early termination of the study.

Outcome measures

Outcome data not reported

Adverse Events

Ceftobiprole Medocaril

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cefepime With or Without Vancomycin

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceftobiprole Medocaril 500 mg every 8 hours - 120-minute infusion \[250 mL\]	Cefepime With or Without Vancomycin n=2 participants at risk 2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
Infections and infestations Bacteraemia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Infections and infestations Sepsis	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.

Other adverse events

Additional Information

Clincal Team Lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phone: 908 927-3785

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Ceftobiprole Medocaril 500 mg every 8 hours - 120-minute infusion \[250 mL\]	Cefepime With or Without Vancomycin n=2 participants at risk 2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
Gastrointestinal disorders Anorectal disorder	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Gastrointestinal disorders Diarrhoea	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Gastrointestinal disorders Dyspepsia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Gastrointestinal disorders Constipation	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	100.0% 2/2 • The first subject completed on day 41 and the second subject completed on day 56.
Gastrointestinal disorders Stomatitis	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Gastrointestinal disorders Vomiting	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Psychiatric disorders Depression	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Psychiatric disorders Insomnia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Injury, poisoning and procedural complications Procedural Pain	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	100.0% 2/2 • The first subject completed on day 41 and the second subject completed on day 56.
Skin and subcutaneous tissue disorders Rash	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Skin and subcutaneous tissue disorders Skin hemorrhage	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Blood and lymphatic system disorders Thrombocytopenia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Blood and lymphatic system disorders Anemia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Blood and lymphatic system disorders Febrile Neutropenia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Metabolism and nutrition disorders Dehydration	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Metabolism and nutrition disorders Hypokalemia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Metabolism and nutrition disorders Hypomagnesemia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Respiratory, thoracic and mediastinal disorders Epistaxis	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Infections and infestations escherichia bacteremia	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
General disorders Catheter- related complication	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.
Ear and labyrinth disorders Ear pain	— 0/0 • The first subject completed on day 41 and the second subject completed on day 56.	50.0% 1/2 • The first subject completed on day 41 and the second subject completed on day 56.