NCT02979951 Fosfomycin I.v. for Treatment of Severely Infected Patients
| NCT ID | NCT02979951 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Infectopharm Arzneimittel GmbH |
| Condition | Bacterial Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2016-12 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2016-12 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this European, multicentric, prospective, non-interventional study is to document and evaluate the efficacy and safety of the treatment of severely infected patients with intravenously administered fosfomycin, including patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infections, each as far as covered by the respective nationally relevant SmPC.
Eligibility Criteria
Inclusion Criteria: * Male or female patients aged ≥ 18 years * Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v. * Patients with osteomyelitis, complicated urinary tract infection, nosocomial lower respiratory tract infection, bacterial meningitis/central nervous system infection, bacteraemia/sepsis, skin and soft tissue infection, endocarditis or other infection, each as far as covered by the respective nationally relevant SmPC * Written informed consent of the participant (or person in charge in case of patients incapable of giving consent) Exclusion Criteria: * Previous documentation of the patient in the present study * Patients participating in an interventional clinical trial * Patients with known hypersensitivity to fosfomycin or any of the excipients * Terminally ill patients * Patients with "do not resuscitate order" * Palliative treatment approach * Failure of \> 3 of the following organ systems: respiratory system, nervous system, cardiovascular system, liver, coagulation, kidney * Manifest Human Immunodeficiency Virus (HIV) disease (Acquired Immunodeficiency Syndrome, AIDS) * Fosfomycin treatment as 4th line treatment or at later stage * Patients with involvement of fungi or mycobacteria in the targeted infection
Contact & Investigator
Thomas Borrmann, Dr.
✉ Clinical.Trials@infectopharm.comKlaus-Friedrich Bodmann, Dr.
STUDY DIRECTOR
Klinik Nordoberpfalz AG, Klinikum Weiden
Frequently Asked Questions
Who can join the NCT02979951 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacterial Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02979951 currently recruiting?
Yes, NCT02979951 is actively recruiting participants. Contact the research team at Clinical.Trials@infectopharm.com for enrollment information.
Where is the NCT02979951 trial being conducted?
This trial is being conducted at Hall in Tirol, Austria, Reutte, Austria, Vienna, Austria, Wels, Austria and 11 additional locations.
Who is sponsoring the NCT02979951 clinical trial?
NCT02979951 is sponsored by Infectopharm Arzneimittel GmbH. The principal investigator is Klaus-Friedrich Bodmann, Dr. at Klinik Nordoberpfalz AG, Klinikum Weiden. The trial plans to enroll 1,000 participants.