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Study of the Safety and Effectiveness of Doripenem Among Patients With Hospital Acquired Pneumonia, Intra-abdominal Infections and Urinary Tract Infections

2014-08-27 03:19:45 | BioPortfolio

Summary

The purpose of this study is to assess the safety and effectiveness of doripenem (a new antibiotic which inhibits bacterial cell wall synthesis) in treating nosocomial pneumonia (pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal infections and complicated urinary tract infections

Description

The is an open-label (all people involved know the identity of the intervention), multi-center study, to evaluate the safety and effectiveness of doripenem (a new antibiotic which inhibits bacterial cell wall synthesis) in treating Thai patients with nosocomial pneumonia (pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal infections and complicated urinary tract infections. Eligible patients will receive 500 mg of doripenem infused intravenously (directly into the vein) over 1 -4 hours, 3 times daily for 7-14 days. 500 mg of doripenem infused intravenously (directly into the vein) over 1 -4 hours, 3 times daily for 7-14 days

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infection

Intervention

Doripenem

Location

Bangkok
Thailand

Status

Recruiting

Source

Janssen-Cilag Ltd.,Thailand

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:45-0400

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Medical and Biotech [MESH] Definitions

Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.

A nontuberculous infection when occurring in humans. It is characterized by pulmonary disease, lymphadenitis in children, and systemic disease in AIDS patients. Mycobacterium avium-intracellulare infection of birds and swine results in tuberculosis.

Infection involving the tissues or organs in the PELVIS.

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An infection at a specific location that may spread to another region of the body.

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