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| Name | Class |
|---|---|
| Peninsula Pharmaceuticals, Inc. | INDUSTRY |
The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).
Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consists of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit. The patients will receive either doripenem or comparator for 7 to 14 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doripenem | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate at the early follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response rate at the late follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, vital signs, laboratory test results) conducted throughout the study.. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20459721 | Derived | Kollef MH, Nathwani D, Merchant S, Gast C, Quintana A, Ketter N. Medical resource utilization among patients with ventilator-associated pneumonia: pooled analysis of randomized studies of doripenem versus comparators. Crit Care. 2010;14(3):R84. doi: 10.1186/cc9012. Epub 2010 May 10. | |
| 20211892 | Derived | Kaniga K, Flamm R, Tong SY, Lee M, Friedland I, Redman R. Worldwide experience with the use of doripenem against extended-spectrum-beta-lactamase-producing and ciprofloxacin-resistant Enterobacteriaceae: analysis of six phase 3 clinical studies. Antimicrob Agents Chemother. 2010 May;54(5):2119-24. doi: 10.1128/AAC.01450-09. Epub 2010 Mar 8. |
| Label | URL |
|---|---|
| A Multicenter, Randomized, Open-Label, Phase 3 Study to Compare the Safety and Efficacy of Intravenous Doripenem with that of Intravenous Imipenem in Ventilator-Associated Pneumonia | View source |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077726 | Doripenem |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| 19670912 | Derived | Zhanel GG, Ketter N, Rubinstein E, Friedland I, Redman R. Overview of seizure-inducing potential of doripenem. Drug Saf. 2009;32(9):709-16. doi: 10.2165/00002018-200932090-00001. |
| D000077299 |
| Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |