Clinical trial NCT01173575: Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection
Official title: Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
Collaborators: name: J&P Medical Research Ltd.
name: Sandoz GmbH
First posted: 2010-08-02
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
city: Tübingen
country: Germany
facility: University Hospital Tübingen
state: Baden-Württemberg
city: Augsburg
country: Germany
facility: Augsburg Hospital
state: Bavaria
city: Krumbach
country: Germany
facility: Kreisklinik Guenzburg Krumbach
state: Bavaria
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
city: Weiden In Der Oberpfalz
country: Germany
facility: Weiden Hospital
state: Bavaria
city: Munich
country: Germany
facility: University Hospital Munich
state: Bayern
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
city: Oldenburg
country: Germany
facility: Evangelische Krankenhausstiftung Oldenburg
state: Lower Saxony
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg gGmbH
state: Lower Saxony
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück
state: Lower Saxony
city: Greifswald
country: Germany
facility: University Hospital Greifswald
state: Mecklenburg-Vorpommern
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center North Rhine-Westphalia
state: NRW
city: Bochum
country: Germany
facility: Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum
state: NRW
city: Bonn
country: Germany
facility: University of Bonn (Orthopedics)
state: NRW
city: Bonn
country: Germany
facility: University of Bonn (Anesthesiology)
state: NRW
city: Cologne
country: Germany
facility: University Hospital Cologne (Cardiothoracic Surgery)
state: NRW
city: Cologne
country: Germany
facility: University Hospital Cologne (Internal Medicine)
state: NRW
city: Cologne
country: Germany
facility: Hospital Cologne-Merheim
state: NRW
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf
state: NRW
city: Muenster
country: Germany
facility: University Hospital Muenster
state: NRW
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Charite University Hospital Berlin
city: Berlin
country: Germany
facility: Paulinenhaus Krankenanstalt e.V.
Study officials:
References:
citation: Putensen C, Ellger B, Sakka SG, Weyland A, Schmidt K, Zoller M, Weiler N, Kindgen-Milles D, Jaschinski U, Weile J, Lindau S, Kieninger M, Faltlhauser A, Jung N, Teschendorf P, Adamzik M, Grundling M, Wahlers T, Gerlach H, Litty FA. Current clinical use of intravenous fosfomycin in ICU patients in two European countries. Infection. 2019 Oct;47(5):827-836. doi: 10.1007/s15010-019-01323-4. Epub 2019 Jun 12.