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Effect of Ceftobiprole on Human Intestinal Microflora

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Basilea Pharmaceutica
ClinicalTrials.gov Identifier:
NCT00965042
First received: August 21, 2009
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.


Condition Intervention Phase
Antimicrobial Agent
Cephalosporins
Drug Resistance
 Drug: Ceftobiprole
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Ceftobiprole on the Intestinal Human Microflora Following Multiple-dose Administration in Healthy Female and Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

Primary Outcome Measures:
  • Bacterial strains and numbers in feces; Minimum inhibitory concentrations for ceftobiprole for isolated resistant strains [ Time Frame: Day 2, 4, 7, 10, 14 and 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fecal concentration of ceftobiprole [ Time Frame: Day 2, 4, 7, 10, 14 and 21 ] [ Designated as safety issue: No ]
  • Plasma Concentration of ceftobiprole [ Time Frame: Day 1, 4, 7, 10, 14, and 21 ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftobiprole
Ceftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days
 Drug: Ceftobiprole
ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days

Detailed Description:

This is an open-label, single center study to investigate the effect on human intestinal microflora of multiple doses of ceftobiprole treatment administered at 8 hours intervals for 7 consecutive days. Careful investigation of the effect of Ceftobiprole treatment on the intestinal microflora is of importance since alteration of the intestinal microflora balance may facilitate colonization by pathogenic bacteria strains or enable microorganisms already present in the normal microflora to develop resistance. A total of 7 fecal samples will be collected on day 2, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in fecal, intestinal microflora pattern and measuring the susceptibility for Ceftobiprole of isolated bacterial strains. A total of 13 plasma samples will be collected on day 1, 4, 7, 10, 14 and 21 for determination of ceftobiprole concentration in plasma. Safety evaluations including physical examination, vital signs, clinical laboratory tests, electrocardiogram and adverse event monitoring will be performed throughout the study. 500 mg ceftobiprole, intravenous infusion over 120 minutes, every 8 hours for 7 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Healthy volunteers with body weight >= 50 kg and body mass index between 18 and 30

  • Agree to remain hospitalized at the trial unit during the 7-day drug administration period and will only leave the trial unit under supervision of a study nurse twice a day for one hour maximum
  • Refrain from excessive jogging and any strenuous exercise during the study
  • Be able to adhere to the dietary, fluid and smoking restrictions during the study
  • Have negative pregnancy test result at the screening and agree to use adequate contraception method and not to become pregnant or donate sperm throughout the study

Exclusion Criteria:

  • No clinically significant medical illness, abnormal findings in physical examination, vital signs, laboratory tests and electrocardiogram, or known allergy to the study drug, cephalosporins, beta-lactam antibiotics or other clinically significant allergies requiring treatment
  • No antibiotic treatment within the last 3 months
  • No drug or alcohol abuse within the last 5 years
  • No blood donation or substantial loss of blood of more than 500 ml within the last 3 months or intention to donate blood during the study or within 1 month after study completion
  • No history of smoking of more than 10 cigarettes , or 2 cigars, or 2 pipes of tobacco or 5 sniffs per day within the last 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965042

Sponsors and Collaborators
Basilea Pharmaceutica
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Publications:

Responsible Party: Basilea Pharmaceutica
ClinicalTrials.gov Identifier: NCT00965042     History of Changes
Other Study ID Numbers: CR016306, BAC-1002
Study First Received: August 21, 2009
Last Updated: July 27, 2012
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
Sweden: Medical Products Agency

Keywords provided by Basilea Pharmaceutica:
Ceftobiprole
ZEVTERA
ZEFTERA
Intestinal Microflora

Additional relevant MeSH terms:
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013