SinusitisNCT00245427
Outcomes of Patients Not Responding to Antibiotics in the Community
A study testing all macrolide antibiotics and all beta-lactam antibiotics in people with Sinusitis and Bronchitis, Chronic, run by CPL Associates at 1 site in United States.
Trial summary
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community Read more about this study
- Who is it for?
- Ages Up to 95 years
- Conditions the study is for
- Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial
- What is being tested?
- all macrolide antibiotics and all beta-lactam antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2006
- Phase
- Interventional
- 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 Up to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have failed to respond to at least three (ABECB and CAP) or five (AMS/ABRS/AECRS) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(ABECB), community acquired pneumonia(CAP) and acute maxillary sinusitis(AMS) will be eligible for enrollment. All patients, whether enrolled retrospectively or concurrently, must have a positive culture. The pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). The isolate must be sent to the Study Coordinating Center for precise MIC determination.
Who cannot join
- Patients presenting with any of the following will not be included in the study:
- Life expectancy <3 months from underlying disease
- Underlying lung carcinoma
- Cystic fibrosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Patients Not Responding to Outpatient Macrolide or b-Lactam Therapy for the Treatment of Community Acquired Pneumonia: Expansion to Include Acute Exacerbations of Chronic Bronchitis and Acute Sinusitis
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
Read the detailed description
To document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. Evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. The isolated pathogen must have a known MIC to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). The isolate must be available to be sent to the central laboratory for MIC testing
- Conditions
- Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial
- Being tested
- all macrolide antibiotics, all beta-lactam antibiotics
- Keywords
- beta-lactam, macrolide, antibiotics
- Medical subject headings
- Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
all macrolide antibioticsDrug
Varies based on antibiotic
all beta-lactam antibioticsDrug
Varies based on antibiotic
| Study group | Role | What they receive |
|---|---|---|
| 1 All macrolide antibiotics | Other | Not described Receives: Drug: all macrolide antibiotics |
| 2 All beta lactam antibiotics | Other | Not described Receives: Drug: all beta-lactam antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Measured: varies
Secondary outcomes (1)
PK/PD pharmacoeconomics
Measured: varies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startDec 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- CPL Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Jerome J Schentag, Pharm.D., Principal investigator, State University of NY at BuffaloJoseph Paladino, Pharm.D., Study director, State University of NY at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245427
- Sponsor's protocol ID
- HMR3647A-6012
- Status last verified
- Oct 2007
- First submitted
- 26 Oct 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Patients Not Responding to Outpatient Macrolide or b-Lactam Therapy for the Treatment of Community Acquired Pneumonia: Expansion to Include Acute Exacerbations of Chronic Bronchitis and Acute Sinusitis
- ClinicalTrials.gov ID
- NCT00245427
- Acronym / sponsor ID
- HMR3647A-6012
- Conditions
- Sinusitis, Bronchitis, Chronic, Pneumonia, Bacterial
- Keywords
- beta-lactam, macrolide, antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- CPL AssociatesUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Dec 2005
- Study completion
- Mar 2006 (actual)
- First posted
- 28 Oct 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.
A study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community
Detailed description
To document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. Evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. The isolated pathogen must have a known MIC to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). The isolate must be available to be sent to the central laboratory for MIC testing
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 All macrolide antibiotics | Other | Drug: all macrolide antibiotics |
| 2 All beta lactam antibiotics | Other | Drug: all beta-lactam antibiotics |
Who may qualify
- Ages
- Up to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have failed to respond to at least three (ABECB and CAP) or five (AMS/ABRS/AECRS) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(ABECB), community acquired pneumonia(CAP) and acute maxillary sinusitis(AMS) will be eligible for enrollment. All patients, whether enrolled retrospectively or concurrently, must have a positive culture. The pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). The isolate must be sent to the Study Coordinating Center for precise MIC determination.
Key exclusion criteria (4 listed)
- Life expectancy <3 months from underlying disease
- Underlying lung carcinoma
- Cystic fibrosis
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 |
|---|---|---|
| all macrolide antibioticsVaries based on antibiotic | Drug | 1 All macrolide antibiotics |
| all beta-lactam antibioticsVaries based on antibiotic | Drug | 2 All beta lactam antibiotics |
Primary outcome
Clinical outcome
Time frame: varies
1 secondary outcome
PK/PD pharmacoeconomics
Time frame: varies
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 31 Oct 2007.
- Related InfoLink provided by the sponsor.
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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.
Jerome J Schentag, Pharm.D. principal investigator
State University of NY at Buffalo
Joseph Paladino, Pharm.D. study director
State University of NY at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing all macrolide antibiotics and all beta-lactam antibiotics in people with Sinusitis and Bronchitis, Chronic, run by CPL Associates 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 1 inclusion and 4 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 31 Oct 2007. 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.
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?
Clinical outcome (time frame: varies). 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 31 Oct 2007.