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

NCT ID: NCT00502801

Last Updated: 2013-09-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia Bacterial Pneumonia Ventilator-Associated Pneumonia Infections, Nosocomial

Keywords

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Pneumonia Lung Infection Bacterial Infection Hospital-Acquired Infection Ventilator Infection Antibiotic Therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doripenem

1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Group Type EXPERIMENTAL

doripenem

Intervention Type DRUG

1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Interventions

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doripenem

1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PriCara, Unit of Ortho-McNeil, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial

Role: STUDY_DIRECTOR

PriCara, Unit of Ortho-McNeil, Inc.

Locations

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Palm Springs, California, United States

Site Status

San Francisco, California, United States

Site Status

Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

Site Status

Jacksonville, Florida, United States

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Miami, Florida, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Hazard, Kentucky, United States

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Baltimore, Maryland, United States

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Springfield, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Buffalo, New York, United States

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Flushing, New York, United States

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Jamaica, New York, United States

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Toledo, Ohio, United States

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Providence, Rhode Island, United States

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Johnson City, Tennessee, United States

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Nashville, Tennessee, United States

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Norfolk, Virginia, United States

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Morgantown, West Virginia, United States

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Buenos Aires, , Argentina

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Santa Fe, , Argentina

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Oshawa, Ontario, Canada

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Chicoutimi, Quebec, Canada

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Concepción, , Chile

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Avenija Gojka Suska 6, , Croatia

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Zagreb, , Croatia

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Argenteuil 95 95, , France

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Jaipur, , India

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Kozhikode, , India

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Manipal, , India

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Noida, , India

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Pune, , India

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Novosibirsk, , Russia

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Kharkiv, , Ukraine

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Ukraine Poltava, , Ukraine

Site Status

Countries

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United States Argentina Canada Chile Croatia France India Russia Ukraine

Other Identifiers

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DORIINI2002

Identifier Type: OTHER

Identifier Source: secondary_id

CR012931

Identifier Type: -

Identifier Source: org_study_id