Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00505258
Other study ID # CR013807
Secondary ID
Status Withdrawn
Phase Phase 2
First received July 19, 2007
Last updated February 19, 2013
Est. completion date April 2009

Study information

Verified date February 2013
Source Basilea Pharmaceutica
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ceftobiprole medocaril


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Basilea Pharmaceutica

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
See also
  Status Clinical Trial Phase
Completed NCT03894046 - Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex Phase 3
Active, not recruiting NCT03354338 - Amoxicillin to Prevent Bacteria and Inflammatory Biomarkers After Intensive Periodontal Therapy Phase 2
Withdrawn NCT02543957 - Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
Completed NCT02210169 - RCT of Continuous Versus Intermittent Infusion of Vancomycin in Neonates N/A
Completed NCT01410578 - The Value of sTREM-1, PCT, and CRP as Markers for the Detection of Sepsis and Bacteremia Among Patients With a FUO N/A
Terminated NCT00428051 - Colombia Epidemiologic Surveillance Study N/A
Completed NCT00609375 - Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen Phase 4
Completed NCT00177736 - Pharmacodynamic Parameters of Two Different Doses of Cefepime Phase 4
Terminated NCT00108433 - Linezolid in the Treatment of Hemodialysis Patients With Catheter-Related Gram-Positive Bloodstream Infections Phase 3
Completed NCT00571259 - Prophylactic Antimicrobial Catheter Lock Phase 4
Completed NCT00027248 - Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections Phase 3
Completed NCT05585463 - Safety of Acupuncture and Intracutaneous Needles in Pediatric Cancer Patients: a Retrospective Study (ACUSAFE2021)
Recruiting NCT05950984 - Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK)
Completed NCT03148769 - Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
Completed NCT02536352 - Effect of Supplementation of Fluoride on Maternal Periodontal Health, Preterm Delivery, and Perinatal Well-Being Early Phase 1
Completed NCT02869191 - Blood Cultures's Profitability in Intensive Care Unit
Terminated NCT01734694 - Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Phase 4
Completed NCT01179022 - Incidence of Bacteremia Following Argon Plasma Coagulation in Patients With Endobronchial Lesions N/A
Recruiting NCT00404625 - Infections Caused by ESbL-Producing Enterobacteriaceae in Italy N/A
Completed NCT00398411 - Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells Phase 3