PneumoniaPhase 4COBRA IINCT00237445
Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days
A Phase 4 study testing telithromycin and azithromycin in people with Pneumonia, run by Sanofi at 1 site in United States.
Trial summary
A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- telithromycin and azithromycin
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2006
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 20 or greater.
- Subjects with a positive Binax NOW S. pneumoniae Urinary Antigen Test and/or positive gram stain for diplococci.
- Subjects with ≤ 7 days of signs and symptoms of CAP.
- Subjects with chest x-ray findings that support a diagnosis of acute pneumonia with presence of a new infiltrate. For subjects with history of chronic obstructive pulmonary disease (COPD), a comparison to previous chest x-ray report is required to confirm the finding of new infiltrates.
- Subjects with diagnosis of acute mild to moderate CAP based on at least one of the following:
- fever (oral >37.5°C/99.5°F or axillary >37.4°C/99.4°F or rectal >38.5°C/101.5°F) or
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- elevated total peripheral white blood cell count >10,000/mm3 or >15% immature neutrophils (bands), regardless of total peripheral white count and
- new and sudden onset (equal or less than 48 hours) of at least two of the following signs or symptoms:
- cough
- dyspnea or tachypnea (particularly if progressive in nature)
- pleuritic chest pain
- purulent sputum production or change in sputum character
- auscultatory findings (such as rales and/or evidence of pulmonary consolidation)
Who cannot join
- Subjects presenting with any of the following will not be included in the study.
- Subjects with CAP requiring hospitalization.
- Subjects with signs and symptoms of severe CAP lasting greater than 7 days.
- Subjects requiring parenteral antibiotic treatment.
- Subjects discharged from hospital within the 10 days before study entry.
- Subjects with visible/gross aspiration pneumonia.
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- Subjects with any concomitant pulmonary disease, condition or complication that could confound the interpretation or evaluation of drug efficacy or safety, including:
- severe bronchiectasis, cystic fibrosis or suspected active pulmonary tuberculosis
- suspected acute pulmonary embolism
- emphysema, lung abscess, extra pulmonary extension (e.g., meningitis, septic arthritis, endocarditis)
- known bronchial obstruction or a history of postobstructive pneumonia.
- Subjects with neoplastic lung disease (lung cancer) or another malignancy metastatic to the lungs, and/or requiring chemotherapeutic interventions for this or other neoplasms.
- Subjects with infection requiring administration of other systemic antimicrobial agents.
- Subjects with progressively fatal disease; life expectancy ≤3 months.
- Subjects with myasthenia gravis.
- Subjects with any concomitant condition, including severe and/or uncontrolled cardiovascular, neurologic, endocrine, or other severe and/or uncontrolled major systemic disease that make implementation of the protocol or interpretation of the study results difficult.
- Immunocompromised subjects, such as:
- known HIV subjects with CD4+ T-lymphocyte count dated less than 3 months <200/mm3 and /or HIV subjects treated with isoniazide or clarithromycin as prophylaxis
- neutropenia (<1500 neutrophils/mm3) not attributable to the acute infectious disease
- metastatic or hematological malignancy
- splenectomy or known hyposplenia or asplenia
- chronic corticosteroid therapy.
- Subjects with a history of congenital or a family history of long QT syndrome (if not excluded by previous ECG) and subjects with known acquired QT interval prolongation
- Known severe impaired renal function as shown by creatinine clearance < 30 ml/min either measured or estimated with Cockroft formula.
- Subjects who have received more than 24 hours of effective treatment with other antibiotics, within the 7 days prior to enrollment in the study.
- Subjects with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to telithromycin or any macrolide antibiotic.
- Subjects who will require on-study treatment with medications known to have potential drug interactions, including ergot alkaloids derivatives, terfenadine, astemizole, cisapride, pimozide, simvastatin, atorvastatin and lovastatin (see Section 6.2).
- Subjects who have received any investigational drug within 1 month prior to study entry or such treatment is planned for during the study period.
- Subjects who are pregnant or breast-feeding.
- Subjects with recent drug or alcohol abuse.Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subject is the investigator or any subinvestigator, research assistance, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Subjects already enrolled in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multinational, Multicenter, Randomized, Double-blind, Study in Areas of High Pneumococcal Resistance Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days
A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
- Conditions
- Pneumonia
- Being tested
- telithromycin, azithromycin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telithromycinDrug
azithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).
Secondary outcomes (1)
To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Phyllis Diener, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237445
- Sponsor's protocol ID
- HMR3647A_4027
- Acronym
- COBRA II
- Status last verified
- Jan 2011
- First submitted
- 10 Oct 2005
- Last updated
- 11 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Multicenter, Randomized, Double-blind, Study in Areas of High Pneumococcal Resistance Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Ketek® Telithromycin Once Daily for 7 Days, or Zithromax® Azithromycin Once Daily for 5 Days
- ClinicalTrials.gov ID
- NCT00237445
- Acronym / sponsor ID
- COBRA II / HMR3647A_4027
- Conditions
- Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 12 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 multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female outpatients aged 20 or greater.
- Subjects with a positive Binax NOW S. pneumoniae Urinary Antigen Test and/or positive gram stain for diplococci.
- Subjects with ≤ 7 days of signs and symptoms of CAP.
- Subjects with chest x-ray findings that support a diagnosis of acute pneumonia with presence of a new infiltrate. For subjects with history of chronic obstructive pulmonary disease (COPD), a comparison to previous chest x-ray report is required to confirm the finding of new infiltrates.
- Subjects with diagnosis of acute mild to moderate CAP based on at least one of the following:
Key exclusion criteria (32 listed)
- Subjects presenting with any of the following will not be included in the study.
- severe bronchiectasis, cystic fibrosis or suspected active pulmonary tuberculosis
- suspected acute pulmonary embolism
- emphysema, lung abscess, extra pulmonary extension (e.g., meningitis, septic arthritis, endocarditis)
- known bronchial obstruction or a history of postobstructive pneumonia.
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 |
|---|---|---|
| telithromycin | Drug | – |
| azithromycin | Drug | – |
Primary outcome
Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).
1 secondary outcome
To compare the effect of telithromycin versus azithromycin on clinical efficacy in CAP adult outpatients at the end of therapy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2011.
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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.
Phyllis Diener study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing telithromycin and azithromycin in people with Pneumonia, run by Sanofi 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 13 inclusion and 32 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: stopped early, as of the sponsor's last update on 11 Jan 2011. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early. Results are not available in the source record.
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?
Evaluate clinical cure rates of telithromycin over azithromycin for treating adult outpatients with mild to moderate community-acquired pneumonia (CAP) in high pneumococcal bacterial resistance areas, at the test of cure visit (Days 17-21).. 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 11 Jan 2011.