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

A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia; Ventilator-Associated Pneumonia; Bacterial Pneumonia; Infections, Nosocomial
• Intervention / Treatment: Drug: doripenem

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.

• Study Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Santa Fe, Argentina
• Canada
  • Ontario
    • Oshawa, Ontario, Canada
  • Quebec
    • Chicoutimi, Quebec, Canada
• Chile
  • Concepcion, Chile
• Croatia
  • Avenija Gojka Suska 6, Croatia
  • Zagreb, Croatia
• France
  • Argenteuil 95 95, France
• India
  • Jaipur, India
  • Kozhikode, India
  • Manipal, India
  • Noida, India
  • Pune, India
• Russian Federation
  • Novosibirsk, Russian Federation
• Ukraine
  • Kharkiv, Ukraine
  • Ukraine Poltava, Ukraine
• United States
  • California
    • Palm Springs, California, United States
    • San Francisco, California, United States
  • Colorado
    • Denver, Colorado, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Jacksonville, Florida, United States
    • Miami, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Decatur, Georgia, United States
  • Kentucky
    • Hazard, Kentucky, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Springfield, Massachusetts, United States
  • Michigan
    • Grand Rapids, Michigan, United States
  • Missouri
    • Columbia, Missouri, United States
    • Saint Louis, Missouri, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New York
    • Buffalo, New York, United States
    • Flushing, New York, United States
    • Jamaica, New York, United States
  • Ohio
    • Toledo, Ohio, United States
  • Rhode Island
    • Providence, Rhode Island, United States
  • Tennessee
    • Johnson City, Tennessee, United States
    • Nashville, Tennessee, United States
  • Virginia
    • Norfolk, Virginia, United States
  • West Virginia
    • Morgantown, West Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.	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.	5 to 21 days after the last dose of study therapy, or at early termination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Response Rates at the Late Follow-up Assessment.	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.	28 to 35 days after last dose of study therapy

Collaborators and Investigators

• Sponsor: PriCara, Unit of Ortho-McNeil, Inc.
• Investigators: Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial, PriCara, Unit of Ortho-McNeil, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: July 16, 2007
• First Submitted That Met QC Criteria: July 16, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): September 25, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Pneumonia; Hospital-Acquired Infection; Bacterial Infection; Lung Infection; Antibiotic Therapy; Ventilator Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Iatrogenic Disease; Healthcare-Associated Pneumonia; Infections; Pneumonia; Pneumonia, Bacterial; Pneumonia, Ventilator-Associated; Cross Infection; Anti-Infective Agents; Anti-Bacterial Agents; Doripenem
• Other Study ID Numbers: CR012931; DORIINI2002 (Other Identifier: PriCara, Unit of Ortho-McNeil, Inc.)