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Ceftobiprole in the Treatment of Hospitalized Patients With Staphylococcus Aureus Bacteremia
This study has been withdrawn prior to recruitment.
( The study was withdrawn due to lack of an appropriate patient population. No screened patients met inclusion and exclusion criteria. )
First Received: July 19, 2007   Last Updated: March 7, 2008   History of Changes
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00505258
  Purpose

The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.


Condition Intervention Phase
Bacteremia
 Drug: ceftobiprole medocaril
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Open-Label Study Evaluating the Safety and Rate of Bacterial Clearance of Ceftobiprole 500 Milligram Every 8 Hours Compared to Conventional Therapy in the Treatment of Hospitalized Subjects With Staphylococcus Aureus Bacteremia

Resource links provided by NLM:

Drug Information available for: Ceftobiprole Ceftobiprole Medocaril
U.S. FDA Resources

Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • To determine the effect of ceftobiprole on the time to bloodstream clearance of methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus (MSSA) in treated bacteremic patients.

Secondary Outcome Measures:
  • To determine the effect of ceftobiprole versus comparator on the time to bloodstream clearance of MRSA and MSSA, respectively and bloodstream clearance of MRSA compared to MSSA in bacteremic patients.

Estimated Enrollment: 45
Study Start Date: August 2007
Detailed Description:

Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus aureus) activity. Ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections. S. aureus is a major human pathogen. It causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues. Particularly challenging and difficult to treat are blood-borne infections (bacteremia). Bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body. MRSA strains are increasing in prevalence, incidence, and virulence. Moreover, the frequency of patients presenting with persistent MRSA bacteremia appears to be rising. The objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with MRSA and MSSA (methicillin-susceptible Staphylococcus aureus) in bacteremic patients. Patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator. The primary end point is time to bloodstream clearance of MRSA and MSSA in patients.

Patients will be randomized to either ceftobiprole or comparator for 7 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol - Female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study
  • And have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening

Exclusion Criteria:

  • - Female patients who are pregnant or lactating
  • - Known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications - Receipt of vancomycin or other antistaphylococcal drug for > 2 calendar days prior to initiation of study drug - Diagnosis of a catheter-related GPC-cl bacteremia at the time of study enrollment - Clinical findings of left-sided endocarditis prior to enrollment or any time during study participation - Requirement for surgery during the seven days of study therapy administration with the exception of surgery required to manage a complication of S. aureus bacteremia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505258

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

No publications provided

Study ID Numbers: CR013807
Study First Received: July 19, 2007
Last Updated: March 7, 2008
ClinicalTrials.gov Identifier: NCT00505258     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Staphylococcus aureus
Staphylococcal Infections
Bloodstream infection
 MSSA
Bacteremia
MRSA

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Cephalosporins
Sepsis
 Pathologic Processes
Therapeutic Uses
Bacteremia
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010



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