Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

This study is being discontinued due to issues regarding the comparator, cefepime. In Nov 2007 FDA issued a MedWatch regarding cefepime and the trial was suspended. As of May 14, 2008 the FDA was still evaluating the data on cefepime and final follow up is pending. There were no safety issues with ceftobiprole in this study based on the enrollment of 2 subjects in September of 2007. The study is being discontinued for administrative reasons. Ceftobiprole medocaril is a cephalosporin antibiotic with anti-MRSA (Methicillin-Resistant Staphylococcus Aureus) activity. Ceftobiprole is not yet approved, but undergoing regulatory review for treatment of skin infections. This is a randomized (patients are assigned to receive the different treatments under study based on chance), double-blind (neither the patient nor the physician knows whether the drug being investigated or the comparator agent is being taken), multicenter study of treatment with ceftobiprole medocaril versus treatment with a comparator in patients 18 years of age or older, who have fever and neutropenia after chemotherapy for cancer that requires intravenous therapy. Patients will be randomly assigned to receive either ceftobiprole medocaril or comparator. In addition, patients in the comparator group who are at risk of serious infections due to gram-positive pathogens (disease-causing bacteria) may also receive an antibiotic with MRSA activity. The study will consist of the following 3 phases: a prerandomization phase (includes screening and baseline assessments); a treatment phase, and a follow-up phase consisting of a primary efficacy visit and a late follow-up visit. The primary endpoint is the clinical cure rate. The total duration of of the study is determined by the time to resolution of fever and neutropenia and the conditions associated with the episode of fever and neutropenia. This is followed by the primary efficacy visit (7 to 10 days after the end of therapy) and the late follow-up visit (28 to 35 days after the end of treatment). Cultures (samples of blood or other suspected sites of infection) will be collected during the study as well as blood samples for hematology and chemistry (safety assessments). All adverse events will also be reported throughout the study and for about 4 to 5 weeks after the last dose of study drug. Patients will be randomized to either ceftobiprole or comparator for approximately 7 to 14 days. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00529282
Study type Interventional
Source Basilea Pharmaceutica
Contact
Status Terminated
Phase Phase 3
Start date October 2007
Completion date January 2008

See also
  Status Clinical Trial Phase
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03706599 - Fever Infants and Therapeutic Education in Emergency Department N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT01782183 - Thermographic Characteristics of Sore Throat by Thermographic Camera N/A
Withdrawn NCT00800696 - Preventive Oral Care N/A
Completed NCT02212990 - The Effect of Prophylactic Antipyretics on Immune Responses and Fever After 2014-2015 and 2015-2016 Inactivated Influenza Vaccine N/A
Completed NCT02689193 - IDIS Project Work Package 2: Establishing a Biobank at ITM and Collaborating Centres
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Completed NCT01869699 - Effects of Intravenous Acetaminophen on Body Temperature and Hemodynamic Responses in Febrile Critically Ill Adults Phase 4
Completed NCT01194557 - Introducing Rapid Diagnostic Tests Into the Private Health Sector N/A
Completed NCT01559675 - Trial Comparing Low Dose and High Dose Steroids in Patients Undergoing Colorectal Surgery N/A
Completed NCT00969176 - Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates Phase 2/Phase 3
Completed NCT00940654 - The Fever and Antipyretic in Critically Illness Evaluation Study N/A
Recruiting NCT00729976 - Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study. Phase 4
Recruiting NCT00389272 - Adding a Second Drug for Febrile Children Treated With Acetaminophen N/A
Completed NCT00257790 - The Tobramycin Study Phase 4
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease
Completed NCT02595827 - Non-inferiority Trial of Conditional vs Universal Follow up for Children With Fever in Democratic Republic of Congo Phase 3
Recruiting NCT06061575 - Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients Phase 4
Recruiting NCT06038617 - Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children Phase 4