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The primary objective of this study is to compare the safety and efficacy of an experimental antibiotic to a marketed antibiotic in the treatment of Chinese subjects with complicated intra-abdominal infections. <br />
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | armDesc1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tigecycline | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response for all microbiologically evaluable and microbiologically modified intent-to-treat subjects at the test-of-cure visit |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological response at the subject and pathogen level and evaluation of microbiological data, such as decreased susceptibility, response rates by baseline isolate and minimal inhibitory concentration (MIC) values and susceptibility data by isolate |
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Inclusion Criteria:
· Hospitalized male or female subjects over 18 years of age
Exclusion Criteria:
· Subjects with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up visits could be completed.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For China, medinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guoxuexiang | Chengdu | 610041 | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20663130 | Derived | Chen Z, Wu J, Zhang Y, Wei J, Leng X, Bi J, Li R, Yan L, Quan Z, Chen X, Yu Y, Wu Z, Liu D, Ma X, Maroko R, Cooper A. Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial. BMC Infect Dis. 2010 Jul 21;10:217. doi: 10.1186/1471-2334-10-217. | |
| 19036670 |
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| Shengyang |
| Liaoning |
| 110001 |
| China |
| Hangzhou | Zhejiang | China |
| Beijing | 100044 | China |
| Beijing | 100730 | China |
| Beijing | 100853 | China |
| Shanghai | 200001 | China |
| Shanghai | 200040 | China |
| Shanghai | 200092 | China |
| Shanghai | 200433 | China |
| Wuhan | 300063 | China |
| Fomin P, Koalov S, Cooper A, Babinchak T, Dartois N, De Vane N, Castaing N, Tellado J; 301 And 306 Study Groups. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience. J Chemother. 2008 Oct;20 Suppl 1:12-9. doi: 10.1179/joc.2008.20.Supplement-1.12. |
| ID | Term |
|---|---|
| D018784 | Abdominal Abscess |
| D010538 | Peritonitis |
| D017714 | Community-Acquired Infections |
| D003428 | Cross Infection |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D013492 | Suppuration |
| D007239 | Infections |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078304 | Tigecycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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