PneumoniaPhase 3NCT00643227
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Clarithromycin Extended Release for the Treatment of Pneumonia in Adult Patients
A Phase 3 study testing clarithromycin extended release (ER) and azithromycin SR in people with Pneumonia, run by Pfizer at 72 sites in 8 countries.
Trial summary
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- clarithromycin extended release (ER) and azithromycin SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 72 sitesin 8 countries
- Study dates
- Jan 2003to Mar 2004
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
Who cannot join
- Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
Trial locations and contacts
72 sites in 8 countries.
72 sites in 8 countries
United States36 sites
Pfizer Investigational Site
Birmingham, Alabama, 35215
Pfizer Investigational Site
Birmingham, Alabama, 35242
Pfizer Investigational Site
Boise, Idaho, 83703
Pfizer Investigational Site
Boise, Idaho, 83704
Pfizer Investigational Site
Boise, Idaho, 83706
Pfizer Investigational Site
Boise, Idaho, 83709
Pfizer Investigational Site
Boise, Idaho, 83713
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Casper, Wyoming, 82601
Pfizer Investigational Site
Chalmette, Louisiana, 70043
Pfizer Investigational Site
Charleston, South Carolina, 29406
Pfizer Investigational Site
Clemmons, North Carolina, 27012
Pfizer Investigational Site
Haleyville, Alabama, 35565
Pfizer Investigational Site
Holmdel, New Jersey, 07733
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
Meridian, Idaho, 83642
Pfizer Investigational Site
Mesa, Arizona, 85201
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Montgomery, Alabama, 36109
Pfizer Investigational Site
Nampa, Idaho, 83651
Pfizer Investigational Site
New Orleans, Louisiana, 70112
Pfizer Investigational Site
New Orleans, Louisiana, 70128
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Phoenix, Arizona, 85014
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Summerville, South Carolina, 29485
Pfizer Investigational Site
Tallassee, Alabama, 36078
Pfizer Investigational Site
Taylorsville, Utah, 84118
Pfizer Investigational Site
Tempe, Arizona, 85282
Pfizer Investigational Site
West Jordan, Utah, 84088
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Canada12 sites
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Coquitlam, British Columbia, V3K 3P4
Pfizer Investigational Site
Drummondville, Quebec, J2B 1H8
Pfizer Investigational Site
Edmonton, Alberta, T5A 4L8
Pfizer Investigational Site
Granby, Quebec, J2G 8Z9
Pfizer Investigational Site
Longueuil, Quebec, J4N 1E1
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Saint-Jérôme, Quebec, J7Z 5T3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2
Pfizer Investigational Site
Ste-Foy, Quebec, G1V 4G5
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
India6 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Coimbatore, Tamil Nadu, 641 022
Pfizer Investigational Site
Elamakkara, Cochin, Kerala, 682 026
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Ludhiana, Punjab, 141 001
Pfizer Investigational Site
Pune, Maharashtra, 411 053
Russia6 sites
Pfizer Investigational Site
Moscow, 105077
Pfizer Investigational Site
Moscow, 105229
Pfizer Investigational Site
Moscow, 107066
Pfizer Investigational Site
Moscow, 119048
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Smolensk, 214019
Argentina5 sites
Pfizer Investigational Site
Buenos Aires, 1427
Pfizer Investigational Site
Buenos Aires, C1120AAF
Pfizer Investigational Site
Buenos Aires, C1272AAA
Pfizer Investigational Site
Buenos Aires, C1282AFQ
Pfizer Investigational Site
Tandil, Buenos Aires, B7000AXD
Estonia4 sites
Pfizer Investigational Site
Tallinn, 10617
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tallinn, 13619
Pfizer Investigational Site
Tartu, 51014
Lithuania2 sites
Pfizer Investigational Site
Kaunas, LT-3000
Pfizer Investigational Site
Vilnius, LT-2010
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
The study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
- Conditions
- Pneumonia
- Being tested
- clarithromycin extended release (ER), azithromycin SR
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clarithromycin extended release (ER)Drug
7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily
azithromycin SRDrug
Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: clarithromycin extended release (ER) |
| 2 | Experimental | Not described Receives: Drug: azithromycin SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Measured: Test of Cure (TOC) visit (Day 14-21)
Secondary outcomes (10)
bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Measured: TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
Measured: TOC visit
sponsor assessment of clinical response by baseline pathogen
Measured: End of Treatment (EOT) visit (Day 8-11) and TOC visit
sponsor assessment of clinical response in the non-primary population
Measured: EOT visit and TOC visit
sponsor assessment of clinical responses in the Clinical Per Protocol population
Measured: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
susceptibilities of baseline pathogens
Measured: Study endpoint
adverse events
Measured: Continuous
vital signs
Measured: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
physical examination
Measured: Baseline
clinical laboratory assessments (blood chemistry and hematology)
Measured: Baseline and TOC visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startJan 2003
- Study completionMar 2004
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 PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643227
- Sponsor's protocol ID
- A0661075
- Status last verified
- Mar 2008
- First submitted
- 19 Mar 2008
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Clarithromycin Extended Release for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
- ClinicalTrials.gov ID
- NCT00643227
- Acronym / sponsor ID
- A0661075
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Mar 2004 (actual)
- First posted
- 26 Mar 2008 (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 study was performed to confirm that a single, 2.0 g oral dose of azithromycin sustained release (SR) at least as effective as 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily, when used to treat adults with mild to moderate community acquired pneumonia (CAP), and that both treatments were safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: clarithromycin extended release (ER) |
| 2 | Experimental | Drug: azithromycin SR |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients with a diagnosis of pneumonia, as demonstrated by a productive cough and at least 2 of the following signs and symptoms: rales and/or evidence of pulmonary consolidation; dyspnea or tachypnea; elevated body temperature; or elevated total peripheral white blood cell count (WBC >10,000/mm3) or greater than 15% immature neutrophils were included. Patients were to have a chest radiograph demonstrating evidence of a new infiltrate or consolidation, and a Modified Fine Risk score of ≤ 70 (Fine Class I and II).
Key exclusion criteria (1 listed)
- Patients who were treated with any systemic antibiotic of greater than 1 dose or 1 combination dose (such as cephalosporin and macrolide) within the previous 7 days, or the likelihood of receiving other systemic antibiotics during participation in the study; were hospitalized in the previous 14 days or had an infection acquired in the hospital, and who were residents of a long-term care facility were excluded.
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 |
|---|---|---|
| clarithromycin extended release (ER)7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily | Drug | 1 |
| azithromycin SRSingle, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily | Drug | 2 |
Primary outcome
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Day 14-21)
10 secondary outcomes
bacteriologic response (eradication rate) in the Bacteriological Per Protocol population
Time frame: TOC visit
investigator assessment of clinical response in the Clinical Per Protocol population
Time frame: TOC visit
sponsor assessment of clinical response by baseline pathogen
Time frame: End of Treatment (EOT) visit (Day 8-11) and TOC visit
sponsor assessment of clinical response in the non-primary population
Time frame: EOT visit and TOC visit
sponsor assessment of clinical responses in the Clinical Per Protocol population
Time frame: EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35)
susceptibilities of baseline pathogens
Time frame: Study endpoint
adverse events
Time frame: Continuous
vital signs
Time frame: Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit
physical examination
Time frame: Baseline
clinical laboratory assessments (blood chemistry and hematology)
Time frame: Baseline and TOC visit
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 26 Mar 2008.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
72 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clarithromycin extended release (ER) and azithromycin SR in people with Pneumonia, run by Pfizer at 72 sites in 8 countries.
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 1 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 26 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada, India, Russia, Argentina and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population (time frame: Test of Cure (TOC) visit (Day 14-21)). 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 26 Mar 2008.