Doripenem in the Treatment of Ventilator-Associated Pneumonia

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.318 enrolled

Overview

The purpose of this study is to compare the clinical response rate of doripenem versus comparator in patients with ventilator-associated pneumonia (VAP).

Doripenem is an antibiotic medication not yet approved by the US FDA. This is a phase 3, multicenter, prospective, randomized, open-label study of doripenem versus comparator to assess the effectiveness and safety of doripenem in the treatment of VAP in adult patients. The study consists of screening phase, open-label treatment phase, and follow-up. The treatment duration is from 7 to 14 days. The primary endpoint is the clinical response rate of doripenem at the early follow-up visit. The patients will receive either doripenem or comparator for 7 to 14 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

318

Conditions

Pneumonia Ventilators, Mechanical

Interventions

doripenemDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient has received mechanical ventilation for \> 24 hours * Presence of a new or progressive infiltrate on chest x-ray Exclusion Criteria: * Believed at study entry to have ventilator-associated pneumonia caused solely by pathogen(s) resistant to certain antibiotics * History of moderate or severe hypersensitivity reactions to certain antibiotics

Outcomes

Primary Outcomes

Clinical response rate at the early follow-up visit.

Secondary Outcomes

Clinical response rate at the late follow-up visit. Microbiological response at both early and late follow-up visits. Safety assessment (adverse events, vital signs, laboratory test results) conducted throughout the study..

Data from ClinicalTrials.gov

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