An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:
NCT00502801
First received: July 16, 2007
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.


Condition Intervention Phase
Pneumonia
Bacterial Pneumonia
Ventilator-Associated Pneumonia
Infections, Nosocomial
Drug: doripenem
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

Resource links provided by NLM:


Further study details as provided by PriCara, Unit of Ortho-McNeil, Inc.:

Primary Outcome Measures:
  • Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. [ Time Frame: 5 to 21 days after the last dose of study therapy, or at early termination. ] [ Designated as safety issue: No ]
    The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.


Secondary Outcome Measures:
  • Clinical Response Rates at the Late Follow-up Assessment. [ Time Frame: 28 to 35 days after last dose of study therapy ] [ Designated as safety issue: No ]
    The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection.


Enrollment: 185
Study Start Date: August 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Drug: doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Detailed Description:

Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 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 suffering from Nosocomial Pneumonia or Ventilator-Associated Pneumonia
  • All patients must be hospitalized throughout the treatment period
  • Patients must have microbiological samples (respiratory secretions) suitable for culture and microscopy

Exclusion Criteria:

  • Known or suspected severe kidney impairment
  • Known or suspected liver dysfunction
  • Treatment with any investigational drug or device within 30 days before enrollment
  • Patients with one or more of the following: cystic fibrosis, lung abscess, active tuberculosis
  • Women who are pregnant or lactating
  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: NCT00502801

  Show 40 Study Locations
Sponsors and Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial PriCara, Unit of Ortho-McNeil, Inc.
  More Information

No publications provided

Responsible Party: PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier: NCT00502801     History of Changes
Other Study ID Numbers: CR012931, DORIINI2002
Study First Received: July 16, 2007
Results First Received: February 13, 2013
Last Updated: September 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:
Pneumonia
Lung Infection
Bacterial Infection
Hospital-Acquired Infection
Ventilator Infection
Antibiotic Therapy

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Cross Infection
Pneumonia, Ventilator-Associated
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on July 24, 2014