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A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00515034
  Purpose

The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection


Condition Intervention Phase
Abscess, Intra-Abdominal
Pneumonia, Ventilator-Associated
Pneumonia
Pneumonia, Bacterial
Abscess
Drug: Doripenem
Drug: Imipenem/cilastatin
Phase II

MedlinePlus related topics: Pneumonia
Drug Information available for: Cilastatin Doripenem Cilastatin sodium Imipenem
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Doripenem Compared With Imipenem in the Treatment of Subjects With Complicated Intra-Abdominal Infections or Ventilator Associated Pneumonia

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The primary endpoint of this study is the assessment of safety and tolerability of doripenem as measured by the overall incidence of treatment-emergent adverse events (TEAEs). [ Time Frame: 28 to 35 days after the last dose of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome is to compare the clinical cure rate of doripenem with imipenem. [ Time Frame: End of Treatment, Test of Cure (7 to 14 days post end of treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: September 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: Doripenem
1 gram intravenously every 8 hours for 5-14 days
002: Active Comparator Drug: Imipenem/cilastatin
1 gram intravenously every 8 hours for 5-14 days

Detailed Description:

This randomized (study drug assigned by chance), open-label, multicenter study will evaluate the safety and tolerability of doripenem in the treatment of patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Study drug will be administered intravenously (through a vein) for a maximum of 14 days for both indications. Specifically, the target is 7-14 days for patients with VAP and 5-14 days for patients with cIAI. The primary endpoint of this study is to assess the safety and tolerability of doripenem as measured by the overall incidence of treatment-emergent adverse events. The hypothesis for this study is that doripenem has a similar safety profile to imipenem.

Doripenem IV will be administered for a duration of 7 to 14 days for patients with ventilator-associated pneumonia and 5 to 14 days for patients with complicated intra-abdominal infection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP) or complicated Intra-Abdominal Infection (cIAI). Patients with VAP must have been hospitalized (or been in a chronic care facility) for >= 5 days, have received mechanical ventilation for >= 48 hours, have a Clinical Pulmonary Infection Score (CPIS) of >= 5, have new or progressive radiographic infiltrates (not related to another disease process)
  • Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of study entry

Exclusion Criteria:

  • Patients with a history of acute hepatic failure or acute decompensation of chronic hepatic failure, history of severe impairment of renal function, history of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months, organ (including bone marrow) transplant recipients, hematologic malignancy, and use of immunosuppressive therapy at screening, including use of high-dose corticosteroids (e.g., > 40 mg prednisone or equivalent per day for > 2 weeks)
  • History of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515034

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Peninsula Pharmaceuticals, Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Responsible Party: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Franchise Medical Leader )
Study ID Numbers: CR012934, DORINOS2001
Study First Received: August 10, 2007
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00515034  
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Nosocomial
Intra-abdominal infection
Ventilator-associated pneumonia
Pneumonia
Abscess
Bacterial pneumonia

Study placed in the following topic categories:
Bacterial Infections
Abdominal Abscess
Pneumonia, Ventilator-Associated
Inflammation
Imipenem
Respiratory Tract Diseases
Respiratory Tract Infections
Cilastatin
Abscess
Pneumonia, Bacterial
Lung Diseases
Suppuration
Pneumonia
Cross Infection

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Bacterial Agents
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009