NCT01173575

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
2 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2010

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2010

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 2, 2019

Status Verified

February 1, 2016

Enrollment Period

6.3 years

First QC Date

July 29, 2010

Last Update Submit

July 1, 2019

Conditions

Bacterial Infection

Study Arms (1)

Bacterial Infection

All Patients with bacterial infection receiving fosfomycin may be included

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any subject with bacterial infection considered suitable for routine antimicrobial therapy with FOM may be included into this analysis.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Medical University Graz

Graz, Styria, 8035, Austria

Location

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Augsburg Hospital

Augsburg, Bavaria, 86156, Germany

Location

Kreisklinik Guenzburg Krumbach

Krumbach, Bavaria, 86381, Germany

Location

University Hospital Munich

Munich, Bavaria, 81377, Germany

Location

University Hospital Regensburg

Regensburg, Bavaria, 93953, Germany

Location

Weiden Hospital

Weiden in Der Oberpfalz, Bavaria, 92637, Germany

Location

University Hospital Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Evangelische Krankenhausstiftung Oldenburg

Oldenburg, Lower Saxony, 26122, Germany

Location

Klinikum Oldenburg gGmbH

Oldenburg, Lower Saxony, 26131, Germany

Location

Klinikum Osnabrück

Osnabrück, Lower Saxony, 49076, Germany

Location

University Hospital Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

Bochum, North Rhine-Westphalia, 44892, Germany

Location

University of Bonn (Orthopedics)

Bonn, North Rhine-Westphalia, 53105, Germany

Location

University of Bonn (Anesthesiology)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

University Hospital Cologne (Cardiothoracic Surgery)

Cologne, North Rhine-Westphalia, 50924, Germany

Location

University Hospital Cologne (Internal Medicine)

Cologne, North Rhine-Westphalia, 50924, Germany

Location

Hospital Cologne-Merheim

Cologne, North Rhine-Westphalia, 51109, Germany

Location

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Charite University Hospital Berlin

Berlin, 13353, Germany

Location

Paulinenhaus Krankenanstalt e.V.

Berlin, 14055, Germany

Location

Related Publications (1)

  • 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.

    PMID: 31190298DERIVED

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2010

First Posted

August 2, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

July 2, 2019

Record last verified: 2016-02

Locations

DE(24)AU(1)