Trial record 5 of 28 for:    "Abdominal Abscess"

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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00515034
First received: August 10, 2007
Last updated: May 9, 2011
Last verified: May 2011
  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
Pneumonia, Ventilator-Associated
Pneumonia, Bacterial
Pneumonia
Abdominal Abscess
Bacterial Infections
Drug: Imipenem/cilastatin
Drug: Doripenem
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Patients With VAP Who Were Clinically Cured [ Time Frame: 7 to 14 days after the end of IV therapy ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 146
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Drug: Doripenem
1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
Active Comparator: 002
Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Drug: Imipenem/cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion
Experimental: 003
Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion
Drug: Doripenem
1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days
Active Comparator: 004
Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion
Drug: Imipenem/cilastatin
Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

Detailed Description:

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-emergent adverse events are defined as adverse events that occur or worsen between the initial infusion of study drug up to 30 days after the last dose of study drug. The hypothesis for this study is that doripenem has a similar safety profile to imipenem. Doripenem (1g at 8-hour intervals over a period of 4 hours) or imipenem/cilastatin (1g at 8-hours over a period of 1 hour) will be administered by intravenous (iv) infusion (delivery of drug slowly into the vein over a period of time). Patients diagnosed with ventilator associated pneumonia (VAP) will be treated for 7 to 14 days and patients with complicated intra-abdominal infections (cIAI) will be treated for 5 to 14 days.

  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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515034

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

No publications provided

Responsible Party: Senior Director Clinical Development, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00515034     History of Changes
Other Study ID Numbers: CR012934, DORINOS2001
Study First Received: August 10, 2007
Results First Received: November 13, 2009
Last Updated: May 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Doripenem
Imipenem
Cilastatin
Vancomycin
DORIBAX, DORIPREX, FINIBAX, DURAPTA, PRIMAXIN, Anti Bacterial Agents
Ileus
Hospitalized
Fever

Additional relevant MeSH terms:
Abdominal Abscess
Bacterial Infections
Communicable Diseases
Infection
Intraabdominal Infections
Pneumonia
Pneumonia, Bacterial
Pneumonia, Ventilator-Associated
Abscess
Cross Infection
Lung Diseases
Lung Injury
Respiratory Tract Diseases
Respiratory Tract Infections
Suppuration
Ventilator-Induced Lung Injury
Cilastatin
Imipenem
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014