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
-

Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

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
403
Registration Number
NCT00210990

Doripenem in the Treatment of Hospital-Acquired 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
240
Registration Number
NCT00211003

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

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
478
Registration Number
NCT00210938
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