Effect of Ceftobiprole on Human Intestinal Microflora
July 27, 2012 updated by: Basilea Pharmaceutica
Effect of Ceftobiprole on the Intestinal Human Microflora Following Multiple-dose Administration in Healthy Female and Male Subjects
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ceftobiprole
Ceftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days
|
ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Day 2, 4, 7, 10, 14 and 21
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fecal concentration of ceftobiprole
Time Frame: Day 2, 4, 7, 10, 14 and 21
|
Day 2, 4, 7, 10, 14 and 21
|
|
Plasma Concentration of ceftobiprole
Time Frame: Day 1, 4, 7, 10, 14, and 21
|
Day 1, 4, 7, 10, 14, and 21
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
August 21, 2009
First Submitted That Met QC Criteria
August 21, 2009
First Posted (Estimate)
August 25, 2009
Study Record Updates
Last Update Posted (Estimate)
July 30, 2012
Last Update Submitted That Met QC Criteria
July 27, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR016306
- BAC-1002 (Other Identifier: Basilea Internal Reference)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.