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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502801
• Other study ID #: CR012931
• Secondary ID: DORIINI2002
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2007
• Last updated: September 19, 2013
• Start date: August 2007
• Est. completion date: November 2008

Study information

• Verified date: September 2013
• Source: PriCara, Unit of Ortho-McNeil, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis, Extrinsic Allergic
• Bacterial Pneumonia
• Cross Infection
• Infections, Nosocomial
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Ventilator-Associated
• Ventilator-Associated Pneumonia

Intervention

Drug:
• doripenem
1g i.v. infused over 4 hours every 8 hours for 8 to 14 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PriCara, Unit of Ortho-McNeil, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Chile,  Croatia,  France,  India,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.	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.	5 to 21 days after the last dose of study therapy, or at early termination.	No
Secondary	Clinical Response Rates at the Late Follow-up Assessment.	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.	28 to 35 days after last dose of study therapy	No