Antimicrobial AgentPhase 1NCT00965042
Effect of Ceftobiprole on Human Intestinal Microflora
A Phase 1 study testing Ceftobiprole in people with Antimicrobial Agent and Cephalosporins, run by Basilea Pharmaceutica.
Trial summary
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Agent, Cephalosporins, Drug Resistance
- What is being tested?
- Ceftobiprole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Antimicrobial Agent, Cephalosporins, Drug Resistance
- Being tested
- Ceftobiprole
- Keywords
- Ceftobiprole, ZEVTERA, ZEFTERA, Intestinal Microflora
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftobiproleDrug
ceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Ceftobiprole | Experimental | Ceftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days Receives: Drug: Ceftobiprole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial strains and numbers in feces; Minimum inhibitory concentrations for ceftobiprole for isolated resistant strains
Measured: Day 2, 4, 7, 10, 14 and 21
Secondary outcomes (2)
Fecal concentration of ceftobiprole
Measured: Day 2, 4, 7, 10, 14 and 21
Plasma Concentration of ceftobiprole
Measured: Day 1, 4, 7, 10, 14, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial AgentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965042
- Sponsor's protocol ID
- CR016306
- Other IDs
- BAC-1002
- Status last verified
- Jul 2012
- First submitted
- 21 Aug 2009
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20926263
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ceftobiprole on the Intestinal Human Microflora Following Multiple-dose Administration in Healthy Female and Male Subjects
- ClinicalTrials.gov ID
- NCT00965042
- Acronym / sponsor ID
- CR016306
- Conditions
- Antimicrobial Agent, Cephalosporins, Drug Resistance
- Keywords
- Ceftobiprole, ZEVTERA, ZEFTERA, Intestinal Microflora
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the effect of ceftobiprole treatment on intestinal microflora in healthy volunteers.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceftobiprole | Experimental | Drug: CeftobiproleCeftobiprole 500 mg by 2 hour intravenous infusion every 8 hours for 7 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftobiproleceftobiprole 500 mg by intravenous infusion every 8 hours for 7 days | Drug | Ceftobiprole |
Primary outcome
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
2 secondary outcomes
Fecal concentration of ceftobiprole
Time frame: Day 2, 4, 7, 10, 14 and 21
Plasma Concentration of ceftobiprole
Time frame: Day 1, 4, 7, 10, 14, and 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- Results publication: PubMed 20926263Backstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftobiprole in people with Antimicrobial Agent and Cephalosporins, run by Basilea Pharmaceutica.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00965042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.