Try our beta test site

Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

This study has been completed.
Sponsor:
Collaborators:
J&P Medical Research Ltd.
Sandoz GmbH
Information provided by (Responsible Party):
Infectopharm Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT01173575
First received: July 29, 2010
Last updated: January 31, 2017
Last verified: February 2016
  Purpose

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


Condition
Bacterial Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

Resource links provided by NLM:


Further study details as provided by Infectopharm Arzneimittel GmbH:

Enrollment: 214
Study Start Date: August 2010
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Bacterial Infection
All Patients with bacterial infection receiving fosfomycin may be included

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173575

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

Responsible Party: Infectopharm Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT01173575     History of Changes
Other Study ID Numbers: J&P009SAN/2009
Study First Received: July 29, 2010
Last Updated: January 31, 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacterial Infections
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 27, 2017