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Phase 2 N=183 Treatment

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

Pneumonia · Bacterial Pneumonia · Ventilator-Associated Pneumonia · Infections, Nosocomial

Bottom Line

View on ClinicalTrials.gov: NCT00502801 ↗
Enrolled (actual)
183
Serious AEs
38.3%
Results posted
Sep 2013
Primary outcome: Primary: Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. — 63.9; 66.0; 64.4; 50.0 Percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
doripenem (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
PriCara, Unit of Ortho-McNeil, Inc.
Primary completion
Nov 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment.		 63.9; 66.0; 64.4; 50.0 —
SECONDARY
Clinical Response Rates at the Late Follow-up Assessment.		 83.3; 82.9; 84.2; 80.0 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00502801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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