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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PriCara, Unit of Ortho-McNeil, Inc.
ClinicalTrials.gov Identifier:
NCT00502801
First received: July 16, 2007
Last updated: September 19, 2013
Last verified: September 2013

July 16, 2007
September 19, 2013
August 2007
November 2008   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT00502801 on ClinicalTrials.gov Archive Site
Clinical Response Rates at the Late Follow-up Assessment. [ Time Frame: 28 to 35 days after last dose of study therapy ] [ Designated as safety issue: No ]
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.
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.
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pneumonia
  • Bacterial Pneumonia
  • Ventilator-Associated Pneumonia
  • Infections, Nosocomial
Drug: doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Experimental: Doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days
Intervention: Drug: doripenem
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Chile,   Croatia,   France,   India,   Russian Federation,   Ukraine
 
NCT00502801
CR012931, DORIINI2002
No
PriCara, Unit of Ortho-McNeil, Inc.
PriCara, Unit of Ortho-McNeil, Inc.
Not Provided
Study Director: PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial PriCara, Unit of Ortho-McNeil, Inc.
PriCara, Unit of Ortho-McNeil, Inc.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP