PneumoniaPhase 3NCT00643734
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients
A Phase 3 study testing azithromycin sustained release and levofloxacin in people with Pneumonia, run by Pfizer at 65 sites in 8 countries.
Trial summary
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- azithromycin sustained release and levofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- 65 sitesin 8 countries
- Study dates
- Apr 2003to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Who cannot join
- Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
Trial locations and contacts
65 sites in 8 countries.
65 sites in 8 countries
United States35 sites
Pfizer Investigational Site
Charlotte, North Carolina, 28209
Pfizer Investigational Site
Charlotte, North Carolina, 28210
Pfizer Investigational Site
Charlotte, North Carolina, 28262
Pfizer Investigational Site
Cumberland, Maryland, 21502
Pfizer Investigational Site
Downingtown, Pennsylvania, 19335
Pfizer Investigational Site
Dubuque, Iowa, 52001
Pfizer Investigational Site
Dyersburg, Tennessee, 38024
Pfizer Investigational Site
Elkhorn, Nebraska, 68022
Pfizer Investigational Site
Evansville, Indiana, 47712
Pfizer Investigational Site
Evansville, Indiana, 47714
Pfizer Investigational Site
Greer, South Carolina, 29651
Pfizer Investigational Site
Hickory, North Carolina, 28601
Pfizer Investigational Site
Highlands Ranch, Colorado, 80130
Pfizer Investigational Site
Indianapolis, Indiana, 46254
Pfizer Investigational Site
Kalamazoo, Michigan, 49009
Pfizer Investigational Site
King of Prussia, Pennsylvania, 19406
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Lake Jackson, Texas, 77566
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Menomonee Falls, Wisconsin, 53051
Pfizer Investigational Site
Merrit Island, Florida, 32953
Pfizer Investigational Site
Mesa, Arizona, 85206
Pfizer Investigational Site
Morrisville, Pennsylvania, 19067
Pfizer Investigational Site
Newark, Delaware, 19702
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68144
Pfizer Investigational Site
Phoenix, Arizona, 85014
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Rio Rancho, New Mexico, 87124
Pfizer Investigational Site
Salt Lake City, Utah, 84109
Pfizer Investigational Site
Salt Lake City, Utah, 84121
Pfizer Investigational Site
San Luis Obispo, California, 93401
Pfizer Investigational Site
San Mateo, California, 94403
Pfizer Investigational Site
Walla Walla, Washington, 99362
Pfizer Investigational Site
Yukon, Oklahoma, 73099
Canada10 sites
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kitchener, Ontario, N2C 2N9
Pfizer Investigational Site
Langley, British Columbia, V3A 4H9
Pfizer Investigational Site
Montreal, Quebec, H3H 1V4
Pfizer Investigational Site
North Battleford, Saskatchewan, S9A 0V6
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 4S3
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 7H9
Pfizer Investigational Site
Ste-foy, Quebec, G1V 4P9
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6
Pfizer Investigational Site
Victoriaville, Quebec, G6P 6N2
India7 sites
Pfizer Investigational Site
Bangalore, Karnataka, 560052
Pfizer Investigational Site
Bangalore, Karnataka, 560054
Pfizer Investigational Site
Chennai, Tamil Nadu, 600116
Pfizer Investigational Site
Indore, Madhya Pradesh
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012
Pfizer Investigational Site
Nagpur, Maharashtra
Pfizer Investigational Site
Vellore, Tamil Nadu, 632002
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
Lithuania3 sites
Pfizer Investigational Site
Alytus, LT-4580
Pfizer Investigational Site
Kaunas, LT-3021
Pfizer Investigational Site
Klaipėda, LT-5800
Peru2 sites
Pfizer Investigational Site
San Isidro, Lima region
Pfizer Investigational Site
San Miguel, Lima region
About this study
Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
- Conditions
- Pneumonia
- Being tested
- azithromycin sustained release, placebo, levofloxacin
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin sustained releaseDrug
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose
placeboOther
placebo
levofloxacinDrug
500 mg (two 250 mg capsules) by mouth once daily for 7 days
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: azithromycin sustained release; Other: placebo |
| 2 | Experimental | Not described Receives: Drug: levofloxacin; Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Measured: Test of Cure (TOC) visit (Days 14-21)
Secondary outcomes (9)
laboratory abnormalities
Measured: Baseline and TOC visit
sponsor assessment of clinical response (cure or failure) in the remaining study populations
Measured: EOT visit and TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Measured: EOT visit and TOC visit
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Measured: TOC visit
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Measured: End of Treatment (EOT) visit (Days 8-11)
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Measured: TOC visit
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Measured: Long-Term Follow-Up (LTFU) visit (Days 28-35)
summary of baseline susceptibilities
Measured: Study endpoint
adverse events
Measured: Continuous
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 startApr 2003
- Study completionApr 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
- 468 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
- NCT00643734
- Sponsor's protocol ID
- A0661103
- 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 Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
- ClinicalTrials.gov ID
- NCT00643734
- Acronym / sponsor ID
- A0661103
- Conditions
- Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 468 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2003
- Study completion
- Apr 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 see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.
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: azithromycin sustained release, Other: placebo |
| 2 | Experimental | Drug: levofloxacin, Other: placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.
Key exclusion criteria (1 listed)
- Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.
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 |
|---|---|---|
| azithromycin sustained releaseazithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose | Drug | 1 |
| placeboplacebo | Other | 1 |
| levofloxacin500 mg (two 250 mg capsules) by mouth once daily for 7 days | Drug | 2 |
| placeboplacebo | Other | 2 |
Primary outcome
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: Test of Cure (TOC) visit (Days 14-21)
9 secondary outcomes
laboratory abnormalities
Time frame: Baseline and TOC visit
sponsor assessment of clinical response (cure or failure) in the remaining study populations
Time frame: EOT visit and TOC visit
sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population
Time frame: EOT visit and TOC visit
investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: TOC visit
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: End of Treatment (EOT) visit (Days 8-11)
bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population
Time frame: TOC visit
sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population
Time frame: Long-Term Follow-Up (LTFU) visit (Days 28-35)
summary of baseline susceptibilities
Time frame: Study endpoint
adverse events
Time frame: Continuous
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
65 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 azithromycin sustained release and levofloxacin in people with Pneumonia, run by Pfizer at 65 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 65 sites in United States, Canada, India, Russia, Lithuania and 3 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 (cure or failure) in the Clinical Per Protocol population (time frame: Test of Cure (TOC) visit (Days 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.