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
To compare the efficacy and safety of IV tigecycline to IV levofloxacin in the treatment of subjects with CAP requiring hospitalization.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tigecycline | Drug | |||
| Levofloxacin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response in the clinically evaluable population and the clinical modified intent-to-treat population at the TOC visit. | ||
| Determine whether tigecycline is noninferior to levofloxacin. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22812672 | Derived | Ramirez JA, Cooper AC, Wiemken T, Gardiner D, Babinchak T; 308 Study Group. Switch therapy in hospitalized patients with community-acquired pneumonia: tigecycline vs. levofloxacin. BMC Infect Dis. 2012 Jul 19;12:159. doi: 10.1186/1471-2334-12-159. | |
| 19740418 | Derived | Tanaseanu C, Milutinovic S, Calistru PI, Strausz J, Zolubas M, Chernyak V, Dartois N, Castaing N, Gandjini H, Cooper CA; 313 Study Group. Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia. BMC Pulm Med. 2009 Sep 9;9:44. doi: 10.1186/1471-2466-9-44. |
Not provided
Not provided
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D018410 | Pneumonia, Bacterial |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D011014 | Pneumonia |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 19036672 | Derived | Dartois N, Castaing N, Gandjini H, Cooper A; Tigecycline 313 Study Group. Tigecycline versus levofloxacin for the treatment of community-acquired pneumonia: European experience. J Chemother. 2008 Oct;20 Suppl 1:28-35. doi: 10.1179/joc.2008.20.Supplement-1.28. |
| 18508226 | Derived | Tanaseanu C, Bergallo C, Teglia O, Jasovich A, Oliva ME, Dukart G, Dartois N, Cooper CA, Gandjini H, Mallick R; 308 Study Group; 313 Study Group. Integrated results of 2 phase 3 studies comparing tigecycline and levofloxacin in community-acquired pneumonia. Diagn Microbiol Infect Dis. 2008 Jul;61(3):329-38. doi: 10.1016/j.diagmicrobio.2008.04.009. Epub 2008 May 27. |
| D012141 |
| Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |