Staphylococcus AureusPhase 2NCT00198289
Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
A Phase 2 study testing Aurexis® (tefibazumab) in people with Staphylococcus Aureus, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Staphylococcus Aureus
- What is being tested?
- Aurexis® (tefibazumab)
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2006
- Phase
- Phase 2
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, ages > 7 years old
- Diagnosis of CF as evidenced by sweat chloride test and/or genetic mutation testing
- Sputum SA CFUs > 10,000 per mL
- Ability to expectorate sputum
- Ability to tolerate nasal lavage and collection of breath condensate
- Willing to practice reliable birth control measures during the entire study period, if subject is of childbearing potential
- Informed consent obtained from subject or legal guardian, and assent if appropriate
Who cannot join
- Burkholderia cepacia in sputum
- Subjects who have had changes to their treatment regimen for CF in the past 6 weeks
- Subjects can be screened 6 weeks after IV antibiotic completion
- Subjects can be screened 7 days after oral antibiotic completion
- Received an investigational drug within 30 days of study entry
- Received any immune globulin or blood product within 30 days of study entry
Show all 10Show fewer
- History of hypersensitivity to immune globulin preparations
- Undergoing any type of dialysis or expected to start dialysis within 30 days
- Pregnant or nursing females
- Considered unlikely to comply with the study procedures or to return for scheduled post-treatment evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.
The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
- Conditions
- Staphylococcus Aureus
- Being tested
- Aurexis® (tefibazumab)
- Keywords
- Cystic Fibrosis, Staphylococcus aureus, lungs
- Medical subject headings
- Staphylococcal Infections, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurexis® (tefibazumab)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
Secondary outcomes (5)
To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
Changes in bacterial load of SA in sputum as determined by colony counts
Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Seth Hetherington, M.D., Study director, Inhibitex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198289
- Sponsor's protocol ID
- INH-AUR-004
- Status last verified
- Mar 2013
- First submitted
- 9 Sep 2005
- Last updated
- 29 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs
- ClinicalTrials.gov ID
- NCT00198289
- Acronym / sponsor ID
- INH-AUR-004
- Conditions
- Staphylococcus Aureus
- Keywords
- Cystic Fibrosis, Staphylococcus aureus, lungs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jun 2006
- First posted
- 20 Sep 2005 (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.
Patients who are at least 7 years old with stable Cystic Fibrosis who have Staphylococcus aureus in their Lungs will be enrolled into the study and receive one dose of Aurexis® intravenously on Study Day 1, and will be followed until Study Day 57. Aurexis is a humanized monoclonal antibody that is designed to combat Staphylococcus aureus.
The purpose of this study is to assess the safety and pharmacokinetic profile (concentration of Aurexis in blood and sputum) of Aurexis. Additionally, certain tests and measurements will be conducted to preliminarily determine if Aurexis demonstrates any benefit to these patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, ages > 7 years old
Key exclusion criteria (10 listed)
- Burkholderia cepacia in sputum
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 |
|---|---|---|
| Aurexis® (tefibazumab) | Drug | – |
Primary outcome
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
To evaluate the pharmacokinetics of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs
5 secondary outcomes
To evaluate the biologic and clinical effects of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs on:
Changes in bacterial load of SA in sputum as determined by colony counts
Changes in inflammatory mediators in nasal lavage fluid, breath condensate and plasma, including IL-1β, IL-6, IL-8, and TNFα.
Changes in oxidant/antioxidant balance in nasal lavage, breath condensate and plasma including GSH, GSSG, redox potential, cysteine, and cystine
Changes in pulmonary function tests as determined by FVC, FEV1, and FEF25-75%
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 29 Mar 2013.
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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.
Seth Hetherington, M.D. study director
Inhibitex
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aurexis® (tefibazumab) in people with Staphylococcus Aureus, run by Bristol-Myers Squibb at 1 site in United States.
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 7 inclusion and 10 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To evaluate the safety of a single dose of Aurexis® in stable subjects with CF who are chronically colonized with SA in their lungs. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2013.