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

July 29, 2010
February 5, 2016
August 2010
December 2016   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01173575 on ClinicalTrials.gov Archive Site
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Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection
Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Any subject with bacterial infection considered suitable for routine antimicrobial therapy with FOM may be included into this analysis.
Bacterial Infection
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Bacterial Infection
All Patients with bacterial infection receiving fosfomycin may be included
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
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December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Both
Child, Adult, Senior
No
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
Austria,   Germany
 
NCT01173575
J&P009SAN/2009
No
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Infectopharm Arzneimittel GmbH
Infectopharm Arzneimittel GmbH
  • J&P Medical Research Ltd.
  • Sandoz GmbH
Not Provided
Infectopharm Arzneimittel GmbH
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP