Doripenem: Clinical Trials

26 trials of Doripenem, newest first

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20 completed, 5 terminated, 1 withdrawn. 12 Phase 3, 6 Phase 4, 4 Phase 2, 3 Phase 1, 1 Not applicable.

By phase and status

PhaseTrialsStatus
Phase 312Completed 7, Terminated 4, Withdrawn 1
Phase 46Completed 6
Phase 24Completed 3, Withdrawn 1
Phase 13Completed 2, Terminated 1
Not applicable1Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria
Polymyxin B, Polymyxin B + Doripenem - Bacteremia, Healthcare-associated Pneumonia
Phase 2 / Phase 3WithdrawnTan Tock Seng Hospital2015-01-012019-10-09
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) - Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Phase 3CompletedPfizer5982012-10-012017-09-06
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Ceftazidime - Avibactam ( CAZ-AVI), Doripenem, Either switch to oral therapy: 500 mg of Ciprofloxacin (oral) - Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
Phase 3CompletedPfizer6412012-10-012017-09-06
A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age
Doripenem - Meningitis
Phase 1TerminatedJanssen Research & Development, LLC12012-03-012013-12-06
Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients
Doripenem or Piperacillin/Tazobactam - Septic Shock
Not applicableCompletedUniversity Hospital, Montpellier502012-02-012016-11-29
Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h), Doripenem - Urinary Tract Infections
Phase 2CompletedForest Laboratories2172010-12-012014-02-03
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
Cefepime placebo, Cefepime, Doripenem - Pneumonia, Bacterial, Community-Acquired Infections
Phase 3TerminatedJanssen Research & Development, LLC72010-12-012014-07-15
A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections
Doripenem, Meropenem placebo, Meropenem - Abscess, Intra-Abdominal, Abdominal Abscess
Phase 3TerminatedJanssen Research & Development, LLC412010-12-012014-07-15
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
Doripenem, Doripenem placebo, Cefepime - Complicated Urinary Tract Infections or Pyelonephritis
Phase 3TerminatedJanssen Research & Development, LLC412010-12-012014-07-15
The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia
Doripenem - Ventilator-Associated Pneumonia
Phase 4CompletedSutep Jaruratanasirikul122010-10-012011-11-09
Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1
doripenem - Healthy
Phase 4CompletedMedical University of Vienna62010-08-012011-04-01
Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
Doripenem, doripenem - Febrile Neutropenia
Phase 4CompletedGary E. Stein, Pharm.D.122010-08-012015-10-14
Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients
Doripenem - Sepsis
Phase 4CompletedEmory University302010-04-012014-01-27
A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections
No intervention - Pneumonia, Bacterial, Nosocomial Infection
CompletedJanssen Pharmaceutica1702009-11-012013-08-09
A Study of Doripenem in Infants Less Than 12 Weeks of Age
Doripenem - Bacterial Infections
Phase 1CompletedJanssen Research & Development, LLC522009-10-012013-01-10
PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region
doripenem - Pneumonia, Pneumonia, Ventilator-Associated
Phase 4CompletedJanssen Research & Development, LLC2162009-07-172024-11-19
A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections
Doripenem - Infection, Cross Infection
Phase 4CompletedJanssen-Cilag Ltd.,Thailand2702009-06-012013-10-30
Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects
Doripenem - Healthy
Phase 1CompletedKeith A. Rodvold402009-06-012013-03-14
To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia
Doripenem, Imipenem-Cilastatin, Placebo - Ventilator-Associated Pneumonia
Phase 3TerminatedJohnson & Johnson Pharmaceutical Research & Development, L.L.C.2742008-04-012012-12-28
A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
Imipenem/cilastatin, Doripenem - Pneumonia, Ventilator-Associated, Pneumonia, Bacterial
Phase 2CompletedJohnson & Johnson Pharmaceutical Research & Development, L.L.C.1462007-10-012019-03-19

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Conditions studied

Pneumonia, Ventilator-Associated (10)  ·  Healthcare-Associated Pneumonia (5)  ·  Pneumonia (5)  ·  Urinary Tract Infections (5)  ·  Bacterial Infections (4)  ·  Cross Infection (4)  ·  Infections (4)  ·  Pneumonia, Bacterial (4)  ·  Appendicitis (3)  ·  Intraabdominal Infections (3)  ·  Peritonitis (3)  ·  Abdominal Abscess (2)  ·  Bacterial Infections and Mycoses (2)  ·  Cholecystitis (2)  ·  Ileus (2)

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (7)  ·  Janssen Research & Development, LLC (6)  ·  Pfizer (2)  ·  Emory University (1)  ·  Forest Laboratories (1)  ·  Gary E. Stein, Pharm.D. (1)  ·  Janssen Pharmaceutica (1)  ·  Janssen-Cilag Ltd.,Thailand (1)  ·  Keith A. Rodvold (1)  ·  Medical University of Vienna (1)  ·  PriCara, Unit of Ortho-McNeil, Inc. (1)  ·  Sutep Jaruratanasirikul (1)  ·  Tan Tock Seng Hospital (1)  ·  University Hospital, Montpellier (1)

Countries

United States (12)  ·  Argentina (7)  ·  Ukraine (6)  ·  Brazil (5)  ·  Mexico (5)  ·  Poland (5)  ·  Russia (5)  ·  Germany (4)  ·  Belgium (3)  ·  Bulgaria (3)  ·  Chile (3)  ·  Colombia (3)  ·  Croatia (3)  ·  Czechia (3)  ·  France (3)

Top investigators

Paul Newell, MBBS, MRCP (2)  ·  David Lye, MBBS, FRACP (1)  ·  Gary Stein, PharmD (1)  ·  Jeffrey Salomone, MD (1)  ·  Keith A. Rodvold, Pharm.D. (1)  ·  Larry H. Danziger, Pharm.D. (1)  ·  Mark H. Gotfried, M.D. (1)

Results publications

PMID 19670912, PMID 20211892, PMID 20459721, PMID 27313268, PMID 29912399, PMID 30061279, PMID 30221827, PMID 32602065, PMID 18549664, PMID 21303745, PMID 23148736, PMID 24636429, PMID 26014957, PMID 37700689

NIH funding

2009 (3)