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Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by J&P Medical Research Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
InfectoPharm Arzneimittel und Consilium GmbH
Sandoz GmbH
Information provided by:
J&P Medical Research Ltd.
ClinicalTrials.gov Identifier:
NCT01173575
First received: July 29, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by J&P Medical Research Ltd.:

Estimated Enrollment: 200
Study Start Date: August 2010
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173575

Contacts
Contact: Freyja Maria Jüttner-Smolle, Prof., MD +43/ 316 385 ext 3302 freyja.smolle@medunigraz.at

Locations
Austria
Medical University Graz Not yet recruiting
Graz, Styria, Austria, 8035
Contact: Freyja Maria Smolle-Jüttner, Prof., MD     +43/ 316 385 ext 3302     freyja.smolle@medunigraz.at    
Sponsors and Collaborators
J&P Medical Research Ltd.
InfectoPharm Arzneimittel und Consilium GmbH
Sandoz GmbH
  More Information

No publications provided

Responsible Party: Oliver Mauric, 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: July 29, 2010
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on May 19, 2013