Doripenem

Generic Name
Doripenem
Brand Names
-
Drug Type
Small Molecule
Chemical Formula
C15H24N4O6S2
CAS Number
148016-81-3
Unique Ingredient Identifier
BHV525JOBH
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
Associated Therapies
-

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients

Phase 4
Completed
Conditions
Interventions
First Posted Date
2009-12-09
Last Posted Date
2014-01-27
Lead Sponsor
Emory University
Target Recruit Count
30
Registration Number
NCT01027897
Locations
🇺🇸

Grady Memorial Hospital, Atlanta, Georgia, United States

PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

First Posted Date
2009-09-29
Last Posted Date
2024-11-19
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
216
Registration Number
NCT00986102

Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-06-22
Last Posted Date
2013-03-14
Lead Sponsor
Keith A. Rodvold
Target Recruit Count
40
Registration Number
NCT00925392
Locations
🇺🇸

Pulmonary Associates, PA, Phoenix, Arizona, United States

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

First Posted Date
2005-09-29
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
483
Registration Number
NCT00229060

Doripenem in the Treatment of Ventilator-Associated Pneumonia

Phase 3
Completed
Conditions
First Posted Date
2005-09-21
Last Posted Date
2011-06-10
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Target Recruit Count
318
Registration Number
NCT00211016
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