Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

July 1, 2019 updated by: Infectopharm Arzneimittel GmbH

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8035
        • Medical University Graz
  • Germany
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln
      • Berlin, Germany, 13353
        • Charité University Hospital Berlin
      • Berlin, Germany, 14055
        • Paulinenhaus Krankenanstalt e.V.
    • Baden-Württemberg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • University Hospital Tübingen
    • Bavaria
      • Augsburg, Bavaria, Germany, 86156
        • Augsburg Hospital
      • Krumbach, Bavaria, Germany, 86381
        • Kreisklinik Guenzburg Krumbach
      • Regensburg, Bavaria, Germany, 93953
        • University Hospital Regensburg
      • Weiden In Der Oberpfalz, Bavaria, Germany, 92637
        • Weiden Hospital
    • Bayern
      • Munich, Bayern, Germany, 81377
        • University Hospital Munich
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • University Hospital Frankfurt
    • Lower Saxony
      • Oldenburg, Lower Saxony, Germany, 26122
        • Evangelische Krankenhausstiftung Oldenburg
      • Oldenburg, Lower Saxony, Germany, 26131
        • Klinikum Oldenburg gGmbH
      • Osnabrück, Lower Saxony, Germany, 49076
        • Klinikum Osnabruck
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • University Hospital Greifswald
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Heart and Diabetes Center North Rhine-Westphalia
      • Bochum, NRW, Germany, 44892
        • Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum
      • Bonn, NRW, Germany, 53105
        • University of Bonn (Orthopedics)
      • Bonn, NRW, Germany, 53127
        • University of Bonn (Anesthesiology)
      • Cologne, NRW, Germany, 50924
        • University Hospital Cologne (Cardiothoracic Surgery)
      • Cologne, NRW, Germany, 50924
        • University Hospital Cologne (Internal Medicine)
      • Cologne, NRW, Germany, 51109
        • Hospital Cologne-Merheim
      • Düsseldorf, NRW, Germany, 40225
        • University Hospital Düsseldorf
      • Muenster, NRW, Germany, 48149
        • University Hospital Muenster
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • University Hospital Schleswig-Holstein, Campus Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any subject with bacterial infection considered suitable for routine antimicrobial therapy with FOM may be included into this analysis.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Bacterial Infection
All Patients with bacterial infection receiving fosfomycin may be included

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infectopharm Arzneimittel GmbH

Collaborators

J&P Medical Research Ltd.
Sandoz GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

August 2, 2010

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J&P009SAN/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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