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Trial record 6 of 806 for:    Open Studies | "Bacterial Infections"

Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Infectopharm Arzneimittel GmbH
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: February 5, 2016
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:

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated 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
Genders Eligible for Study:   Both
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

Contacts
Contact: Christian Putensen, Prof., MD +49-228 287 ext 14118 christian.putensen@ukb.uni-bonn.de
Contact: Freyja Maria Jüttner-Smolle, Prof., MD +43-316 385 ext 3302 freyja.smolle@medunigraz.at

Locations
Austria
Medical University Graz Completed
Graz, Styria, Austria, 8035
Germany
University Hospital Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Helene Häberle, MD    +49 (0) 707 1298 6900    helene.haeberle@med.uni-tuebingen.de   
Contact: Annika Dietmann       annika.dietmann@med.uni-tuebingen.de   
Augsburg Hospital Recruiting
Augsburg, Bavaria, Germany, 86156
Contact: Ulrich Jaschinski, MD    +49 (0) 821 4002 311    Ulrich.Jaschinski@klinikum-augsburg.de   
Kreisklinik Guenzburg Krumbach Recruiting
Krumbach, Bavaria, Germany, 86381
Contact: Björn Tauchmann, MD    +49 (0) 8282 95898    Bjoern.Tauchmann@kliniken-gz-kru.de   
Contact: Dieter Scheffelmeier, MD    +49 (0) 8282 95859    dieter.scheffelmeier@kliniken-gz-kru.de   
University Hospital Regensburg Recruiting
Regensburg, Bavaria, Germany, 93953
Contact: Martin Kieninger, MD    +49 (0) 941 944 9055    martin.kieninger@klinik.uni-regensburg.de   
Weiden Hospital Recruiting
Weiden in der Oberpfalz, Bavaria, Germany, 92637
Contact: Andreas Faltlhauser, MD    +49 (0) 961 303 3102    andreas.faltlhauser@kliniken-nordoberpfalz.ag   
Contact: Irene Baunoch    +49 (0) 961 303 3307      
University Hospital Munich Recruiting
Munich, Bayern, Germany, 81377
Contact: Michael Zoller, MD    +49 (0) 894 4007 6424    michael.zoller@med.uni-muenchen.de   
Contact: Marion Weis, MD       marion.weis@med.uni-muenchen.de   
University Hospital Frankfurt Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Patrick Meybohm, Prof., MD    +49 (0) 696 3018 7420    patrick.meybohm@kgu.de   
Contact: Simone Lindau, MD       simone.lindau@kgu.de   
Evangelische Krankenhausstiftung Oldenburg Recruiting
Oldenburg, Lower Saxony, Germany, 26122
Contact: Christian Byhahn, Prof., MD    +49 (0) 441 236 406    anaesthesie@evangelischeskrankenhaus.de   
Contact: Andreas Kraft, MD    +49 (0) 441 236 406    andreas.kraft@evangelischeskrankenhaus.de   
Klinikum Oldenburg gGmbH Recruiting
Oldenburg, Lower Saxony, Germany, 26131
Contact: Andreas Weyland, Prof. MD    +49 (0) 441 403 2571    weyland.andreas@klinikum-oldenburg.de   
Contact: Anja Diers    +49 (0) 441 403 2102    diers.anja@klinikum-oldenburg.de   
Klinikum Osnabrück Recruiting
Osnabrück, Lower Saxony, Germany, 49076
Contact: Sven Pulletz, MD    +49 (0) 541 405 6701    Sven.Pulletz@klinikum-os.de   
University Hospital Greifswald Recruiting
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Contact: Matthias Gründling, MD    +49 (0) 3834 86 5810    matthias.gruendling@uni-greifswald.de   
Contact: Liane Guderian       guderian@uni-greifswald.de   
Heart and Diabetes Center North Rhine-Westphalia Recruiting
Bad Oeynhausen, NRW, Germany, 32545
Contact: Jan Weile, MD    +49 (0) 5731 973 646    jweile@hdz-nrw.de   
Contact: Holm Eickmeyer    +49 (0) 5731 971 331    heickmeyer@hdz-nrw.de   
Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum Recruiting
Bochum, NRW, Germany, 44892
Contact: Michael Adamzik, Prof., MD    +49 (0) 234 299 3001    michael.adamzik@kk-bochum.de   
Contact: Helge Haberl, MD       helge.haberl@kk-bochum.de   
University of Bonn (Orthopedics) Recruiting
Bonn, NRW, Germany, 53105
Contact: Dieter C. Wirtz, Prof., MD    +49 (0) 228 287 14170    dieter.wirtz@ukb.uni-bonn.de   
Contact: Sascha Gravius, MD    +49 (0) 228 287 14903    sascha.gravius@ukb.uni-bonn.de   
University of Bonn (Anesthesiology) Recruiting
Bonn, NRW, Germany, 53127
Contact: Christian Putensen, Prof., MD    +49 (0) 228 2871 4118    christian.putensen@ukb.uni-bonn.de   
University Hospital Cologne (Cardiothoracic Surgery) Recruiting
Cologne, NRW, Germany, 50924
Contact: Thorsten Wahlers, Prof. MD    +49 (0) 221 4783 2508    thorsten.wahlers@uk-koeln.de   
Contact: Antje-Christin Deppe, MD    +49 (0) 221 4783 2586    antje-christin.deppe@uk-koeln.de   
University Hospital Cologne (Internal Medicine) Recruiting
Cologne, NRW, Germany, 50924
Contact: Norma Jung, MD    +49 (0) 221 478 88835    norma.jung@uk-koeln.de   
Contact: Eleonore Thomas    +49 (0) 221 478 5860    eleonore.thomas@uk-koeln.de   
Hospital Cologne-Merheim Recruiting
Cologne, NRW, Germany, 51109
Contact: Samir Sakka, Prof. MD    +49 (0) 221 8907 13430    SakkaS@Kliniken-Koeln.de   
University Hospital Düsseldorf Recruiting
Düsseldorf, NRW, Germany, 40225
Contact: Detlef Kindgen-Milles, Prof., MD    +49 (0) 2118 107 047    kindgen-milles@med.uni-duesseldorf.de   
Contact: Claude Pelletier       claude.pelletier@med.uni-duesseldorf.de   
University Hospital Muenster Recruiting
Muenster, NRW, Germany, 48149
Contact: Björn Ellger, Prof., MD    +49 (0) 251 834 7255    ellger@anit.uni-muenster.-de   
Contact: Daniela Bause    +49 (0) 251 834 7271    bausedan@anit.uni-muenster.de   
University Hospital Schleswig-Holstein, Campus Kiel Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Contact: Norbert Weiler, Prof. MD    +49 (0) 431 597 1025    norbert.weiler@uksh.de   
Contact: Stefanie D'aria    +49 (0) 431 597 4248    stefanie.daria@uksh.de   
Vivantes Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Contact: Gerlach Herwig, Prof. MD    +49 (0) 130 14 2361    herwig.gerlach@vivantes.de   
Contact: Anja Thieme, MD    +49 (0) 130 14 2361    anja.thieme@vivantes.de   
Charite University Hospital Berlin Recruiting
Berlin, Germany, 13353
Contact: Claudia Spies, Prof., MD    +49 (0) 30 450 531 012    claudia.spies@charite.de   
Contact: Katrin Schmidt, MD    +49 (0) 30 450 560 045    kat.schmidt@charite.de   
Paulinenhaus Krankenanstalt e.V. Recruiting
Berlin, Germany, 14055
Contact: Frank-Rainer Klefisch, MD    +49 (0) 303 008 384    Klefisch@paulinenkrankenhaus.de   
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: February 5, 2016
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on September 30, 2016