Effect of Ceftobiprole on Human Intestinal Microflora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00965042
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):
Basilea Pharmaceutica

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

Condition or disease Intervention/treatment Phase
Antimicrobial Agent Cephalosporins Drug Resistance Drug: Ceftobiprole Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Fecal concentration of ceftobiprole [ Time Frame: Day 2, 4, 7, 10, 14 and 21 ]
  2. Plasma Concentration of ceftobiprole [ Time Frame: Day 1, 4, 7, 10, 14, and 21 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00965042

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

Publications of Results:
Responsible Party: Basilea Pharmaceutica Identifier: NCT00965042     History of Changes
Other Study ID Numbers: CR016306
BAC-1002 ( Other Identifier: Basilea Internal Reference )
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by Basilea Pharmaceutica:
Intestinal Microflora

Additional relevant MeSH terms:
Ceftobiprole medocaril
Anti-Bacterial Agents
Anti-Infective Agents