Assessment of the Efficacy of FOSFOMYCIN in Patients With Bacterial Infection

NCT ID: NCT01173575

Last Updated: 2019-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bacterial Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bacterial Infection

All Patients with bacterial infection receiving fosfomycin may be included

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

J&P Medical Research Ltd.

OTHER

Sponsor Role collaborator

Sandoz GmbH

INDUSTRY

Sponsor Role collaborator

Infectopharm Arzneimittel GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University Graz

Graz, Styria, Austria

Site Status

University Hospital Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Augsburg Hospital

Augsburg, Bavaria, Germany

Site Status

Kreisklinik Guenzburg Krumbach

Krumbach, Bavaria, Germany

Site Status

University Hospital Munich

Munich, Bavaria, Germany

Site Status

University Hospital Regensburg

Regensburg, Bavaria, Germany

Site Status

Weiden Hospital

Weiden in Der Oberpfalz, Bavaria, Germany

Site Status

University Hospital Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status

Evangelische Krankenhausstiftung Oldenburg

Oldenburg, Lower Saxony, Germany

Site Status

Klinikum Oldenburg gGmbH

Oldenburg, Lower Saxony, Germany

Site Status

Klinikum Osnabrück

Osnabrück, Lower Saxony, Germany

Site Status

University Hospital Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Heart and Diabetes Center North Rhine-Westphalia

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Medizinische Universitätsklinik Knappschaftskrankenhaus Bochum

Bochum, North Rhine-Westphalia, Germany

Site Status

University of Bonn (Orthopedics)

Bonn, North Rhine-Westphalia, Germany

Site Status

University of Bonn (Anesthesiology)

Bonn, North Rhine-Westphalia, Germany

Site Status

University Hospital Cologne (Cardiothoracic Surgery)

Cologne, North Rhine-Westphalia, Germany

Site Status

University Hospital Cologne (Internal Medicine)

Cologne, North Rhine-Westphalia, Germany

Site Status

Hospital Cologne-Merheim

Cologne, North Rhine-Westphalia, Germany

Site Status

University Hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

University Hospital Muenster

Münster, North Rhine-Westphalia, Germany

Site Status

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status

Charite University Hospital Berlin

Berlin, , Germany

Site Status

Paulinenhaus Krankenanstalt e.V.

Berlin, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 31190298 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

J&P009SAN/2009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Antibiotics on Urinary Microbiome
NCT04230746 WITHDRAWN EARLY_PHASE1