Clinical Trial: A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ventil

Brief Summary: 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.

Detailed Summary: This is a randomized (study drug assigned by chance), open-label (all people involved know the identity of the intervention), multicenter study that will evaluate the safety and tolerability of doripenem (an antibiotic used to treat infections) in patients with ventilator-associated pneumonia (VAP) or complicated intra-abdominal infection (cIAI). Approximately 250 patients will be assigned in a 3:1 ratio to receive doripenem or imipenem/cilastatin (188 patients randomized to receive doripenem and 62 patients randomized to receive imipenem/cilastatin). Furthermore, patients who receive doripenem or imipenem/cilastatin will be stratified by disease (VAP or cIAI). Therefore, for reporting purposes, there will be 4 groups: Patients with VAP treated with doripenem, patients with VAP treated with imipenem/cilastatin, patients with cIAI treated with doripenem, and patients with cIAI treated with imipenem/cilastatin. Study drug will be administered intravenously (iv) (through a vein) for 7 to 14 days for patients with VAP and for 5 to 14 days for patients with cIAI. The maximum duration of study drug is 14 days. Vancomycin and/or amikacin may be added to the study drug regimen as adjunctive therapy for those patients who meet study specified criteria. The recommended dosage of vancomycin is 1 g every 12 hours administered by iv infusion. The addition of amikacin is at the discretion of the investigator for patients with VAP (not cIAI) and the recommended dosing regimen for amikacin is 15 mg/kg given iv once a day. Alternative amikacin regimens or other aminoglycoside regimens may be permitted. Safety will be assessed during the study by the monitoring of adverse events, evaluation of laboratory test results, and changes in vital signs. The primary endpoint of this study is to assess the overall incidence of treatment-emergent adverse events (TEAEs) from the initiation of the first infusion of study drug and up to 30 days after the completion of study drug therapy. Treatment
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: Patients With Incidence of Treatment-emergent Adverse Events (TEAEs). [ Time Frame: from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy ]

Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.


Original Primary Outcome: 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).

Current Secondary Outcome:

  • Patients With VAP Who Were Clinically Cured [ Time Frame: 7 to 14 days after the end of IV therapy ]
    clinical cure is the complete resolution of signs and symptoms of pneumonia or lack of progression of chest x-ray abnormalities to such an extent that no further antimicrobial therapy was necessary.
  • Patients With cIAI Who Were Clinically Cured [ Time Frame: 7 to 14 days after the end of IV therapy ]
    clinical cure is the complete resolution or significant improvement of signs or symptoms of cIAI, such that no additional antimicrobial therapy or surgical or percutaneous intervention is required for the treatment of the current infection.


Original Secondary Outcome: The secondary outcome is to compare the clinical cure rate of doripenem with imipenem.

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: August 10, 2007
Date Started: October 2007
Date Completion:
Last Updated: May 9, 2011
Last Verified: May 2011