Clinical trial NCT00502801: An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia
Official title: A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Bacterial Pneumonia
Ventilator-Associated Pneumonia
Infections, Nosocomial
Keywords: Pneumonia
Lung Infection
Bacterial Infection
Hospital-Acquired Infection
Ventilator Infection
Antibiotic Therapy
Lead sponsor: PriCara, Unit of Ortho-McNeil, Inc.
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.
timeFrame: 5 to 21 days after the last dose of study therapy, or at early termination.
Secondary outcomes:
measure: Clinical Response Rates at the Late Follow-up Assessment.
timeFrame: 28 to 35 days after last dose of study therapy
Other outcomes:
Locations:
city: Palm Springs
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Hazard
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Springfield
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Omaha
country: United States
state: Nebraska
city: Buffalo
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Jamaica
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Providence
country: United States
state: Rhode Island
city: Johnson City
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Norfolk
country: United States
state: Virginia
city: Morgantown
country: United States
state: West Virginia
city: Buenos Aires
country: Argentina
city: Santa Fe
country: Argentina
city: Oshawa
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Concepcion
country: Chile
city: Avenija Gojka Suska 6
country: Croatia
city: Zagreb
country: Croatia
city: Argenteuil 95 95
country: France
city: Jaipur
country: India
city: Kozhikode
country: India
city: Manipal
country: India
city: Noida
country: India
city: Pune
country: India
city: Novosibirsk
country: Russian Federation
city: Kharkiv
country: Ukraine
city: Ukraine Poltava
country: Ukraine
Study officials:
affiliation: PriCara, Unit of Ortho-McNeil, Inc.
name: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: