Effect of Ceftobiprole on Human Intestinal Microflora

Sponsor

Basilea Pharmaceutica (Industry)

Overall Status

Completed

CT.gov ID

NCT00965042

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

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 :

Apr 1, 2009

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Bacterial strains and numbers in feces; Minimum inhibitory concentrations for ceftobiprole for isolated resistant strains [Day 2, 4, 7, 10, 14 and 21]

Secondary Outcome Measures

Fecal concentration of ceftobiprole [Day 2, 4, 7, 10, 14 and 21]
Plasma Concentration of ceftobiprole [Day 1, 4, 7, 10, 14, and 21]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

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