A Study of Ceftobiprole in Patients With Fever and Neutropenia.

NCT00529282 | Terminated Phase 3 Results

• 2 other identifiers: CR014206CEFTOFBN3004
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia

Conditions

Fever; Neutropenia; Gram-positive Bacterial Infections; Pseudomonas Infection

Keywords

Low numbers of neutrophils in the blood; increased body temperature; cancer chemotherapy; ceftobiprole; pseudomonas infections

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate of Ceftobiprole vs Comparator in Patients With Fever and Neutropenia.

  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

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

Secondary Outcomes (3)

• Clinical Cure Regardless of Modification of Therapy

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

• Clinical Success at 72 Hours

  72 hours after starting study drug

• Clinical Cure Without Prophylactic Antibiotics After the End-of-treatment (EOT) Visit up to 28 Days of Study Drug

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

Study Arms (2)

001

EXPERIMENTAL

Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion \[250 mL\]

Drug: Ceftobiprole Medocaril

002

ACTIVE COMPARATOR

Cefepime with or without vancomycin 2 g every 8 hrs-30 min infusion vancomycin 1 000mg every 12 hrs-60 min infusion

Drug: Cefepime with or without vancomycin

Interventions

Ceftobiprole Medocaril DRUG

500 mg every 8 hours

001

Cefepime with or without vancomycin DRUG

120-minute infusion \[250 mL\]

002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with neutropenia and fever associated with administration of chemotherapy for cancer that requires intravenous therapy with antibiotics.

You may not qualify if:

• Patients who have received antibacterial (oral or intravenous ) treatment for more than 24 hours for fever and neutropenia or have received systemic antibacterial therapy in the previous 72 hours for a defined infectious disease
• Patients with known or suspected hypersensitivity to any related anti-infective
• patients with hepatic impairment
• Patients with severe renal impairment
• Patients who are pregnant or lactating
• Patients who are likely to require major surgical intervention for infection.

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

MeSH Terms

Conditions

Fever; Neutropenia; Gram-Positive Bacterial Infections; Pseudomonas Infections

Interventions

ceftobiprole medocaril; Cefepime; Vancomycin

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gram-Negative Bacterial Infections

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

No analysis was performed due to early termination of the study.

Results Point of Contact

• Title: Clincal Team Lead
• Organization: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

908 927-3785

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 14, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 1, 2012
• Results First Posted: March 29, 2010

Record last verified: 2012-07