Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clarithromycin extended release (ER) | Drug | 7 days of clarithromycin extended release (ER), 1.0 g by mouth once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| sponsor assessment of clinical response (clinical cure rate) in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 14-21) |
| Measure | Description | Time Frame |
|---|---|---|
| bacteriologic response (eradication rate) in the Bacteriological Per Protocol population | TOC visit | |
| investigator assessment of clinical response in the Clinical Per Protocol population | TOC visit |
Not provided
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35215 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| azithromycin SR | Drug | Single, 2.0 g oral dose of azithromycin sustained release (SR) by mouth once daily |
|
| sponsor assessment of clinical response by baseline pathogen | End of Treatment (EOT) visit (Day 8-11) and TOC visit |
| sponsor assessment of clinical response in the non-primary population | EOT visit and TOC visit |
| sponsor assessment of clinical responses in the Clinical Per Protocol population | EOT visit and Long-Term Follow-Up (LTFU) visit (Day 28-35) |
| susceptibilities of baseline pathogens | Study endpoint |
| adverse events | Continuous |
| vital signs | Baseline, On-Treatment (OT) visit (Day 3-5), and TOC visit |
| physical examination | Baseline |
| clinical laboratory assessments (blood chemistry and hematology) | Baseline and TOC visit |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| Pfizer Investigational Site | Haleyville | Alabama | 35565 | United States |
| Pfizer Investigational Site | Montgomery | Alabama | 36106 | United States |
| Pfizer Investigational Site | Montgomery | Alabama | 36109 | United States |
| Pfizer Investigational Site | Tallassee | Alabama | 36078 | United States |
| Pfizer Investigational Site | Mesa | Arizona | 85201 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85014 | United States |
| Pfizer Investigational Site | Tempe | Arizona | 85282 | United States |
| Pfizer Investigational Site | La Jolla | California | 92037 | United States |
| Pfizer Investigational Site | San Diego | California | 92128 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83703 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83704 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83706 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83709 | United States |
| Pfizer Investigational Site | Boise | Idaho | 83713 | United States |
| Pfizer Investigational Site | Meridian | Idaho | 83642 | United States |
| Pfizer Investigational Site | Nampa | Idaho | 83651 | United States |
| Pfizer Investigational Site | Chalmette | Louisiana | 70043 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70112 | United States |
| Pfizer Investigational Site | New Orleans | Louisiana | 70128 | United States |
| Pfizer Investigational Site | Butte | Montana | 59701 | United States |
| Pfizer Investigational Site | Holmdel | New Jersey | 07733 | United States |
| Pfizer Investigational Site | Clemmons | North Carolina | 27012 | United States |
| Pfizer Investigational Site | Salisbury | North Carolina | 28144 | United States |
| Pfizer Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29406 | United States |
| Pfizer Investigational Site | Summerville | South Carolina | 29485 | United States |
| Pfizer Investigational Site | Milan | Tennessee | 38358 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84102 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84109 | United States |
| Pfizer Investigational Site | Salt Lake City | Utah | 84121 | United States |
| Pfizer Investigational Site | Taylorsville | Utah | 84118 | United States |
| Pfizer Investigational Site | West Jordan | Utah | 84088 | United States |
| Pfizer Investigational Site | Casper | Wyoming | 82601 | United States |
| Pfizer Investigational Site | Tandil | Buenos Aires | B7000AXD | Argentina |
| Pfizer Investigational Site | Buenos Aires | 1427 | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1120AAF | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1272AAA | Argentina |
| Pfizer Investigational Site | Buenos Aires | C1282AFQ | Argentina |
| Pfizer Investigational Site | Edmonton | Alberta | T5A 4L8 | Canada |
| Pfizer Investigational Site | Coquitlam | British Columbia | V3K 3P4 | Canada |
| Pfizer Investigational Site | St. John's | Newfoundland and Labrador | A1E 2E2 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| Pfizer Investigational Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Pfizer Investigational Site | Drummondville | Quebec | J2B 1H8 | Canada |
| Pfizer Investigational Site | Granby | Quebec | J2G 8Z9 | Canada |
| Pfizer Investigational Site | Longueuil | Quebec | J4N 1E1 | Canada |
| Pfizer Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Pfizer Investigational Site | Saint-Jérôme | Quebec | J7Z 5T3 | Canada |
| Pfizer Investigational Site | Ste-Foy | Quebec | G1V 4G5 | Canada |
| Pfizer Investigational Site | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| Pfizer Investigational Site | Tallinn | 10617 | Estonia |
| Pfizer Investigational Site | Tallinn | 13419 | Estonia |
| Pfizer Investigational Site | Tallinn | 13619 | Estonia |
| Pfizer Investigational Site | Tartu | 51014 | Estonia |
| Pfizer Investigational Site | Hyderabad | Andhra Pradesh | 500 033 | India |
| Pfizer Investigational Site | Bangalore | Karnataka | 560 034 | India |
| Pfizer Investigational Site | Elamakkara, Cochin | Kerala | 682 026 | India |
| Pfizer Investigational Site | Pune | Maharashtra | 411 053 | India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 001 | India |
| Pfizer Investigational Site | Coimbatore | Tamil Nadu | 641 022 | India |
| Pfizer Investigational Site | Kaunas | LT-3000 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-2010 | Lithuania |
| Pfizer Investigational Site | Moscow | 105077 | Russia |
| Pfizer Investigational Site | Moscow | 105229 | Russia |
| Pfizer Investigational Site | Moscow | 107066 | Russia |
| Pfizer Investigational Site | Moscow | 119048 | Russia |
| Pfizer Investigational Site | Moscow | Russia |
| Pfizer Investigational Site | Smolensk | 214019 | Russia |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided