A Phase 3 interventional study of Ceftobiprole Medocaril and Cefepime with or without vancomycin in Fever, Neutropenia and Gram-positive Bacterial Infections, sponsored by Basilea Pharmaceutica. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-01.
Sponsored by Basilea Pharmaceutica · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in patients with fever and neutropenia
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 2 is below the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Basilea Pharmaceutica is the lead sponsor of 56 studies on the registry; 5 are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 15 (71%) have results posted.
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Exclusion Criteria:
Ceftobiprole Medocaril 500 mg every 8 hours 120-minute infusion \[250 mL\]
Drug: Ceftobiprole Medocaril
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
500 mg every 8 hours
120-minute infusion \[250 mL\]
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
Time frame: 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 Cure Regardless of Modification of Therapy
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).
Time frame: 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
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
Time frame: 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
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 unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.
Time frame: 7 to 10 days after end of therapy or before 24 hours of the initiation of the next course of chemotherapy, whichever is shorter.
| Milestone | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin |
|---|---|---|
| Started | 0 | 2 |
| Completed | 0 | 2 |
| Not completed | 0 | 0 |
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
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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
No measurements were reported for this outcome.
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 unmodified initial course of therapy, and receiving no prophylactic antibiotics after the EOT visit.
No measurements were reported for this outcome.
Collected over The first subject completed on day 41 and the second subject completed on day 56.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftobiprole Medocaril | — | — | — |
| Cefepime With or Without Vancomycin | — | 2/2 (100%) | 2/2 (100%) |
| Event | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin |
|---|---|---|
| BacteraemiaInfections and infestations | — | 1/2 |
| SepsisInfections and infestations | — | 1/2 |
| Event | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin |
|---|---|---|
| ConstipationGastrointestinal disorders | — | 2/2 |
| Procedural PainInjury, poisoning and procedural complications | — | 2/2 |
| Anorectal disorderGastrointestinal disorders | — | 1/2 |
| DiarrhoeaGastrointestinal disorders | — | 1/2 |
| DyspepsiaGastrointestinal disorders | — | 1/2 |
| StomatitisGastrointestinal disorders | — | 1/2 |
| VomitingGastrointestinal disorders | — | 1/2 |
| DepressionPsychiatric disorders | — | 1/2 |
| InsomniaPsychiatric disorders | — | 1/2 |
| RashSkin and subcutaneous tissue disorders | — | 1/2 |
| Age Categorical(participants) | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin | Total |
|---|---|---|---|
| <=18 years | — | 0 | 0 |
| Between 18 and 65 years | — | 2 | 2 |
| >=65 years | — | 0 | 0 |
| Gender(participants) | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin | Total |
|---|---|---|---|
| Female | — | 1 | 1 |
| Male | — | 1 | 1 |
| Region of Enrollment(participants) | Ceftobiprole Medocaril | Cefepime With or Without Vancomycin | Total |
|---|---|---|---|
| United States | — | 2 | 2 |
No study locations are listed for this record.
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Basilea Pharmaceutica