Overview
Doripenem is a broad-spectrum, carbapenem antibiotic marketed under the brand name Doribax by Janssen. Doripenem injection was approved by the FDA in 2007 to treat complicated urinary tract and intra-abdominal infections. In a clinical trial of doripenem treatment in ventilator associated pneumonia (vs. imipenem and cilastatin), it was found that doripenem carried an increased risk of death and lower clinical cure rates, resulting in a premature termination of the trial. The FDA revised the doripenem label in 2014 to include a warning against use in ventilator-associated pneumonia and to reiterate its safety and efficacy for its approved indications.
Background
Doripenem is a broad-spectrum, carbapenem antibiotic marketed under the brand name Doribax by Janssen. Doripenem injection was approved by the FDA in 2007 to treat complicated urinary tract and intra-abdominal infections. In a clinical trial of doripenem treatment in ventilator associated pneumonia (vs. imipenem and cilastatin), it was found that doripenem carried an increased risk of death and lower clinical cure rates, resulting in a premature termination of the trial. The FDA revised the doripenem label in 2014 to include a warning against use in ventilator-associated pneumonia and to reiterate its safety and efficacy for its approved indications.
Indication
用于敏感的革兰阳性菌、阴性菌和厌氧菌所致的呼吸系统、尿道、皮肤软组织、脑组织感染、败血症、细菌性心内膜炎等全身性严重感染，各种外科手术后感染等。
Associated Conditions
- Bacterial Infections
- Catheter-related Bloodstream Infection (CRBSI) NOS
- Complicated Intra-Abdominal Infections (cIAIs)
- Complicated Urinary Tract Infection
- Pyelonephritis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed | |||
2005/09/21 | Phase 3 | Completed |
FDA Drug Approvals
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|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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