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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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9 January 2017 |
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Main ID: |
EUCTR2007-003464-22-HU |
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Date of registration:
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26/09/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and Neutropenia
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Scientific title:
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A randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects With Fever and Neutropenia |
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Date of first enrolment:
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20/11/2007 |
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Target sample size:
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340 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003464-22 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: yes
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV):
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Countries of recruitment
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Belgium
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Hungary
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Spain
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Contacts
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Key inclusion & exclusion criteria
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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 ß-human chorionic gonadotropin (ß-hCG) or urine pregnancy test
(depending on local regulations) at screening.
Willing to adhere to the prohibitions and restrictions specified in this
protocol (see Section 4.4, Prohibitions and Restrictions)
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 ß-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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Product Name: ceftobiprole medocaril
Product Code: JNJ-30982081
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: ceftobiprole medocaril
CAS Number: 252188-71-9
Current Sponsor code: JNJ-30982081
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: Maxipime
Product Name: Maxipime (cefepime hydrochloride) 2g/vial powder for injection
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: Cefepime
CAS Number: 88040-23-7
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: ZENGAC
Product Name: ZENGAC (vancomycin hydrochloride) 1 g, powder for solution for injection and for oral solution
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: vancomycin
CAS Number: 1404-93-9
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
Trade Name: Cepimex
Product Name: CEPIMEX (cefepime) 1000 mg/3mL powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: cefepime
CAS Number: 88040-23-7
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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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.
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Main Objective: 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.
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Secondary Objective: 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.
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Secondary ID(s)
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CEFTOFBN3004
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2007-003464-22-BE
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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