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Doripenem

Generic Name
Doripenem
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

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Phase 3
Completed
Conditions
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Interventions
First Posted Date
2012-05-16
Last Posted Date
2017-09-06
Lead Sponsor
Pfizer
Target Recruit Count
641
Registration Number
NCT01599806
Locations
🇺🇦

Research Site, Zaporizhzhya, Ukraine

Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)

Phase 3
Completed
Conditions
Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Interventions
First Posted Date
2012-05-10
Last Posted Date
2017-09-06
Lead Sponsor
Pfizer
Target Recruit Count
598
Registration Number
NCT01595438
Locations
🇺🇦

Research Site, Zaporizhzhya, Ukraine

Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients

Not Applicable
Completed
Conditions
Septic Shock
Interventions
First Posted Date
2012-01-25
Last Posted Date
2016-11-29
Lead Sponsor
University Hospital, Montpellier
Target Recruit Count
50
Registration Number
NCT01517815
Locations
🇫🇷

Saint Eloi Intensive Care Unit - Montpellier University Hospital, Montpellier, France

The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia

Phase 4
Completed
Conditions
Ventilator-Associated Pneumonia
Interventions
First Posted Date
2011-11-09
Last Posted Date
2011-11-09
Lead Sponsor
Sutep Jaruratanasirikul
Target Recruit Count
12
Registration Number
NCT01467648
Locations
🇹🇭

Prince of Songkla University, Hat Yai, Songkla, Thailand

Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients

Phase 4
Completed
Conditions
Febrile Neutropenia
Interventions
First Posted Date
2011-07-25
Last Posted Date
2015-10-14
Lead Sponsor
Gary E. Stein, Pharm.D.
Target Recruit Count
12
Registration Number
NCT01401010
Locations
🇺🇸

Sparrow Hospital, Lansing, Michigan, United States

A Study of Doripenem in Infants Less Than 12 Weeks of Age

Phase 1
Completed
Conditions
Bacterial Infections
Interventions
First Posted Date
2011-06-27
Last Posted Date
2013-01-10
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
52
Registration Number
NCT01381848

A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age

Phase 1
Terminated
Conditions
Meningitis
Interventions
First Posted Date
2011-06-06
Last Posted Date
2013-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
1
Registration Number
NCT01366651

Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1

Phase 4
Completed
Conditions
Healthy
Interventions
First Posted Date
2011-03-09
Last Posted Date
2011-04-01
Lead Sponsor
Medical University of Vienna
Target Recruit Count
6
Registration Number
NCT01311141
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections

Phase 2
Completed
Conditions
Urinary Tract Infections
Interventions
First Posted Date
2011-01-24
Last Posted Date
2014-02-03
Lead Sponsor
Forest Laboratories
Target Recruit Count
217
Registration Number
NCT01281462
Locations
🇹🇷

Investigational Site, Izmir, Turkey

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

Phase 3
Terminated
Conditions
Community-Acquired Infections
Nosocomial Infection
Pneumonia, Ventilator-Associated
Pneumonia, Bacterial
Interventions
First Posted Date
2010-04-26
Last Posted Date
2014-07-15
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
7
Registration Number
NCT01110421
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