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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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Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis

The purpose of this study is to compare the microbiological cure rate of doripenem versus a comparator antibiotic in the treatment of patients with complicated urinary tract infection or p...

A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia

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Doripenem in the Treatment of Ventilator-Associated Pneumonia

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

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

The purpose of this study is to compare the clinical response rates of doripenem versus a comparator antibiotic in treatment of hospitalized patients with complicated intra-abdominal infec...

Doripenem in the Treatment of Complicated Intra-Abdominal Infections

The purpose of this study is to compare the clinical response rate of doripenem versus a comparator in the treatment of hospitalized patients with complicated intra-abdominal infections.

PubMed Articles [6169 Associated PubMed Articles listed on BioPortfolio]

Pharmacokinetics of Doripenem in Healthy Koreans and Monte Carlo Simulations to Explore Optimal Dosage Regimens in Patients with Normal and Enhanced Renal Function.

Dose adjustment is often required in patients with normal or enhanced renal function. The aim of this study is to investigate the pharmacokinetic (PK) properties of doripenem and explore optimal dosin...

The dynamics of integration, viral suppression and cell-cell transmission in the development of occult hepatitis B virus infection.

Out of several phases of HBV infection, the least understood phase is occult hepatitis virus infection. The paucity of data due to non-availability of biological tissues and the prerequisite of ultra-...

Lymphopenia and risk of infection and infection-related death in 98,344 individuals from a prospective Danish population-based study.

Neutropenia increases the risk of infection, but it is unknown if this also applies to lymphopenia. We therefore tested the hypotheses that lymphopenia is associated with increased risk of infection a...

Pharmacological interventions for acute hepatitis C infection.

Hepatitis C virus (HCV) is a single-stranded RNA (ribonucleic acid) virus that has the potential to cause inflammation of the liver. The traditional definition of acute HCV infection is the first six ...

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The 2015 APIC MegaSurvey was completed by 4,078 members to assess infection prevention practices. This study's purpose was to examine MegaSurvey results to relate infection preventionist (IP) certific...

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.

Infection in humans and animals caused by fungi in the class Zygomycetes. It includes MUCORMYCOSIS and entomophthoramycosis. The latter is a tropical infection of subcutaneous tissue or paranasal sinuses caused by fungi in the order Entomophthorales. Phycomycosis, closely related to zygomycosis, describes infection with members of Phycomycetes, an obsolete classification.

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

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