An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-Acquired) Pneumonia - Full Text View

Sponsored by:	PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:	NCT00502801

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 II

MedlinePlus related topics: Pneumonia

Drug Information available for: Doripenem

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

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

Primary Outcome Measures:

Clinical response will be assessed 7 to 14 days after the end of therapy. Serious bacteria burden will be tracked and correlated with clinical response. [ Time Frame: 7 - 14 days posttherapy (last dose of doripenem received). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Long-term clinical response will be assessed 28 to 35 days after the end of therapy.Microbiologic response 7 to 14 days after the end of therapy. Microbiologic evaluation for relapse 28 to 35 days after the end of therapy. [ Time Frame: 7 - 14 days posttherapy (last dose of doripenem received) and 28 - 35 days after the end-of-therapy visit. ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
001: Experimental	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502801

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

info1@veritasmedicine.com

Show 75 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

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Ortho McNeil Janssen Scientific Affairs, LLC ( Vice President, Data Generation )
Study ID Numbers:	CR012931, DORIINI2002
Study First Received:	July 16, 2007
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00502801
Health Authority:	United States: Food and Drug Administration

Keywords provided by PriCara, Unit of Ortho-McNeil, Inc.:

Bacterial Infection
Pneumonia
Ventilator Infection

Hospital-Acquired Infection
Lung Infection
Antibiotic Therapy

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases

Pneumonia, Bacterial
Pneumonia, Ventilator-Associated
Cross Infection
Pneumonia

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 16, 2009