Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

Completed

• Conditions: Bacterial Infection

• Registration Number: NCT01173575
• Lead Sponsor: Infectopharm Arzneimittel GmbH

Brief Summary

This project aims to assess the clinical and microbiological efficacy of fosfomycin(FOM) in patients with bacterial infection.

Primary objective:

• To assess clinical and microbiological efficacy of FOM in patients with bacterial infection.

Secondary objectives:

* To determine the rate and severity of unexpected adverse events.

* To determine the mean duration of therapy with FOM in patients with bacterial infection.

Study design:

Multi-center, non-interventional study

Detailed Description

Please note that InfectoPharm Arzneimittel und Consilium GmbH has taken over sponsor responsibilities for all German sites of this clinical trial with Jannuary 2016 from J\&P MEDICAL RESEARCH LTD.

Study Timeline

• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study Start: 2010-08
• Study First Posted: 2010-08-02
• Status Verified: 2016-02
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

Inclusion Criteria

• Patients with bacterial infection receiving FOM for clinical purposes will be included into the analysis.

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (25)

Medical University Graz; 🇦🇹 Graz, Styria, Austria

University Hospital Tübingen; 🇩🇪 Tübingen, Baden-Württemberg, Germany

Augsburg Hospital; 🇩🇪 Augsburg, Bavaria, Germany

Kreisklinik Guenzburg Krumbach; 🇩🇪 Krumbach, Bavaria, Germany

University Hospital Regensburg; 🇩🇪 Regensburg, Bavaria, Germany

Weiden Hospital; 🇩🇪 Weiden In Der Oberpfalz, Bavaria, Germany

University Hospital Munich; 🇩🇪 Munich, Bayern, Germany

University Hospital Frankfurt; 🇩🇪 Frankfurt, Hessen, Germany

Evangelische Krankenhausstiftung Oldenburg; 🇩🇪 Oldenburg, Lower Saxony, Germany

Klinikum Oldenburg gGmbH; 🇩🇪 Oldenburg, Lower Saxony, Germany

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