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

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.

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Key information

Conditions

Pneumonia Bacterial Infections Bacterial Infections and Mycoses Bacterial Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Infections, Nosocomial Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia, Bacterial Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator-associated Pneumonia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Buenos Aires, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doripenem

Drug

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

Primary outcomes

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.

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 outcomes

Clinical Response Rates at the Late Follow-up Assessment.

Time frame: 28 to 35 days after last dose of study therapy

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.

Sponsors and collaborators

Lead sponsor

PriCara, Unit of Ortho-McNeil, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jul 18, 2007
Registry last updated: Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed