Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by J&P Medical Research Ltd.
Sponsor:
Collaborators:
InfectoPharm Arzneimittel und Consilium GmbH
Sandoz GmbH
Information provided by (Responsible Party):
J&P Medical Research Ltd.
ClinicalTrials.gov Identifier:
NCT01173575
First received: July 29, 2010
Last updated: June 25, 2015
Last verified: June 2015
  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 J&P Medical Research Ltd.:

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

  Eligibility

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
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   
Weiden Hospital Recruiting
Weiden in der Oberpfalz, Bavaria, Germany, 92637
Contact: Andreas Faltlhauser, MD    +49 (0) 961 303 5663    andreas.faltlhauser@kliniken-nordoberpfalz.ag   
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   
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   
University of Bonn Recruiting
Bonn, NRW, Germany, 53127
Contact: Christian Putensen, Prof., MD    +49 (0) 228 2871 4118    christian.putensen@ukb.uni-bonn.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 Cologne Recruiting
Cologne, NRW, Germany, 50924
Contact: Thorsten Wahlers, Prof. MD    +49 (0) 221 4783 2508    thorsten.wahlers@uk-koeln.de   
University Hospital Muenster Recruiting
Muenster, NRW, Germany, 48149
Contact: Björn Ellger, Prof., MD    +49 (0) 251 834 7269    ellger@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   
Paulinenhaus Krankenanstalt e.V. Recruiting
Berlin, Germany, 14055
Contact: Frank-Rainer Klefisch, MD    +49 (0) 303 008 384    Klefisch@paulinenkrankenhaus.de   
Sponsors and Collaborators
J&P Medical Research Ltd.
InfectoPharm Arzneimittel und Consilium GmbH
Sandoz GmbH
  More Information

No publications provided

Responsible Party: J&P Medical Research Ltd.
ClinicalTrials.gov Identifier: NCT01173575     History of Changes
Other Study ID Numbers: J&P009SAN/2009
Study First Received: July 29, 2010
Last Updated: June 25, 2015
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Bacterial Infections
Infection
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015