| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Subjects 18 years of age or older with fever and neutropenia after chemotherapy for cancer, who require i.v. therapy for treatment of fever and neutropenia |
|
| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To demonstrate the noninferiority of ceftobiprole compared with cefepime with or without vancomycin in subjects with fever and neutropenia with regard to clinical cure versus not cured, after completing the initial course of therapy, without modification. |
|
| E.2.2 | Secondary objectives of the trial |
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.
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.
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 end of treatment (EOT) visit.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
General
Men or women 18 years of age or older
Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], contraceptive patch, or male partner sterilization) before entry and throughout the study; have a negative serum b-human chorionic gonadotropin (b-hCG) or urine pregnancy test (depending on local regulations) at screening.
Willing to adhere to the prohibitions and restrictions specified in this protocol.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Disease Specific
Neutropenia associated with administration of chemotherapy for cancer: absolute neutrophil count (ANC) <= 500 cells/mm³. Subjects with ANC <1,000 cells/mm³ within 48 hours after the onset of fever will be enrolled only if their ANC is expected to further decrease to <500 cells/mm³, based on clinical experience with the particular subject or the chemotherapeutic regimen used to treat the subject. If the subject’s ANC does not fall below 500 cells/mm³ within 48 hours of the onset of fever then the study drug should be discontinued.
Fever: single oral temperature (or equivalent) >=38.3°C (101°F) OR temperature of >=38.0°C (100.4°F) for at least 1 hour.
Require i.v. therapy for treatment of fever and neutropenia. |
|
| E.4 | Principal exclusion criteria |
Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment.
Is pregnant or lactating.
Known or suspected hypersensitivity to any related anti-infective (including vancomycin, or b-lactam antibiotics such as penicillins and cephalosporins).
Require only oral antibacterial therapy to treat their fever and neutropenia.
Have received more than 24 hours of oral or i.v. antibacterial treatment for fever and neutropenia or have received systemic antibacterial therapy in the previous 72 hours for a defined infectious disease. (Note: Subjects receiving oral prophylaxis regimens will be eligible for enrollment provided this prophylaxis began before the onset of fever).
Hepatic impairment, defined as an increase to greater than 4 times the upper limits of normal for aspartate aminotransferase (AST) or ALT, or greater than twice the upper limit for bilirubin.
Severe renal impairment (CLCR <25 mL per minute) or require dialysis.
Isolation, in the last 14 days, of pathogenic bacteria resistant to either study drug therapy other than MR staphylococci.
Subjects who are moribund or who are unlikely to survive for at least 1 month.
Subjects with shock (systolic blood pressure <90 mmHg) unresponsive to fluid replacement.
Previously been entered into this study.
Poorly controlled seizure disorder.
Human immunodeficiency virus (HIV) infection.
Neutropenia syndromes that are not associated with chemotherapy for cancer (e.g., chronic benign neutropenia).
Suspected or established infective endocarditis, empyema, intra abdominal infection, lung abscess, pneumonia secondary to bronchial obstruction, meningitis, or osteomyelitis.
Complicated central venous catheter (CVC)-related infection (i.e., CVC infection associated with septic thrombosis, endocarditis, or osteomyelitis).
Likely to require major surgical intervention for infection (i.e., amputation of infected limb, perforation of bowel with secondary peritonitis).
Scheduled for or expected to receive granulocyte transfusions.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Subjects with ventilator-associated pneumonia. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Clinical cure rate - as defined in the protocol, Clinical Efficacy is the ratio of the number of clinically cured subjects to the total number of subjects in the population under consideration, at the primary efficacy visit. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| If the sponsor became aware of new information which had a significant adverse impact on the benefit/risk profile of the compound the study could be terminated. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 3 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 3 |
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