Bacterial Infection Clinical Trial
Official title:
Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection
| NCT number | NCT01173575 |
| Other study ID # | J&P009SAN/2009 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2010 |
| Est. completion date | December 2016 |
| Verified date | February 2016 |
| Source | Infectopharm Arzneimittel GmbH |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 209 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Patients with bacterial infection receiving FOM for clinical purposes will be included into the analysis. Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University Graz | Graz | Styria |
| Germany | Augsburg Hospital | Augsburg | Bavaria |
| Germany | Heart and Diabetes Center North Rhine-Westphalia | Bad Oeynhausen | NRW |
| Germany | Charite University Hospital Berlin | Berlin | |
| Germany | Paulinenhaus Krankenanstalt e.V. | Berlin | |
| Germany | Vivantes Klinikum Neukölln | Berlin | |
| Germany | Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum | Bochum | NRW |
| Germany | University of Bonn (Anesthesiology) | Bonn | NRW |
| Germany | University of Bonn (Orthopedics) | Bonn | NRW |
| Germany | Hospital Cologne-Merheim | Cologne | NRW |
| Germany | University Hospital Cologne (Cardiothoracic Surgery) | Cologne | NRW |
| Germany | University Hospital Cologne (Internal Medicine) | Cologne | NRW |
| Germany | University Hospital Düsseldorf | Düsseldorf | NRW |
| Germany | University Hospital Frankfurt | Frankfurt | Hessen |
| Germany | University Hospital Greifswald | Greifswald | Mecklenburg-Vorpommern |
| Germany | University Hospital Schleswig-Holstein, Campus Kiel | Kiel | Schleswig-Holstein |
| Germany | Kreisklinik Guenzburg Krumbach | Krumbach | Bavaria |
| Germany | University Hospital Muenster | Muenster | NRW |
| Germany | University Hospital Munich | Munich | Bayern |
| Germany | Evangelische Krankenhausstiftung Oldenburg | Oldenburg | Lower Saxony |
| Germany | Klinikum Oldenburg gGmbH | Oldenburg | Lower Saxony |
| Germany | Klinikum Osnabrück | Osnabrück | Lower Saxony |
| Germany | University Hospital Regensburg | Regensburg | Bavaria |
| Germany | University Hospital Tübingen | Tübingen | Baden-Württemberg |
| Germany | Weiden Hospital | Weiden In Der Oberpfalz | Bavaria |
| Lead Sponsor | Collaborator |
|---|---|
| Infectopharm Arzneimittel GmbH | J&P Medical Research Ltd., Sandoz GmbH |
Austria, Germany,
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