Effect of Ceftobiprole on Human Intestinal Microflora

NCT00965042 | Completed Phase 1

• 2 other identifiers: CR016306BAC-1002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Antimicrobial Agent; Cephalosporins; Drug Resistance

Keywords

Ceftobiprole; ZEVTERA; ZEFTERA; Intestinal Microflora

Outcome Measures

Primary Outcomes (1)

• Bacterial strains and numbers in feces; Minimum inhibitory concentrations for ceftobiprole for isolated resistant strains

  Day 2, 4, 7, 10, 14 and 21

Secondary Outcomes (2)

• Fecal concentration of ceftobiprole

  Day 2, 4, 7, 10, 14 and 21

• Plasma Concentration of ceftobiprole

  Day 1, 4, 7, 10, 14, and 21

Study Arms (1)

Ceftobiprole

EXPERIMENTAL

Ceftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days

Drug: Ceftobiprole

Interventions

Ceftobiprole DRUG

ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days

Ceftobiprole

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead

Related Publications (1)

• Backstrom T, Panagiotidis G, Beck O, Asker-Hagelberg C, Rashid MU, Weintraub A, Nord CE. Effect of ceftobiprole on the normal human intestinal microflora. Int J Antimicrob Agents. 2010 Dec;36(6):537-41. doi: 10.1016/j.ijantimicag.2010.07.021.

  PMID: 20926263 RESULT

MeSH Terms

Interventions

ceftobiprole

Study Officials

• Janssen-Cilag International NV Clinical Trial

  Janssen-Cilag International NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2009
• First Posted: August 25, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07