At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 168 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study collects information on adults with serious bacterial infections who are treated with fosfomycin given through a drip into a vein (intravenous, meaning into the bloodstream). The infections covered include bone infections (osteomyelitis), complicated urine infections, chest infections such as pneumonia, infections around the brain, blood infections (sepsis), skin infections, heart valve infections and others.
Who can take part
- Adults aged 18 or over, male or female
- Receiving fosfomycin treatment that follows the national product information (Summary of Product Characteristics)
- Have one of the serious infections listed, such as bone infection, complicated urine infection, chest infection picked up in hospital, brain or spinal cord infection, blood infection or sepsis, skin or soft tissue infection, or heart valve infection
- Written informed consent from the patient, or from the person responsible if the patient cannot consent
Who may not be able to
- Already recorded in this study before
- Taking part in another interventional clinical trial (a study that tests a treatment)
- Known severe allergy to fosfomycin or any of its other ingredients
- Terminally ill patients
- Patients with a 'do not resuscitate' order
- Receiving palliative treatment (care focused on comfort rather than cure)
- Failure of more than 3 major organs (breathing, nervous system, heart and blood vessels, liver, blood clotting, or kidneys)
- Advanced HIV infection (AIDS, Acquired Immune Deficiency Syndrome)
- Fosfomycin being used as the 4th choice of treatment or later
- Infection involving fungi or mycobacteria (another type of germ)
What taking part involves
- • Fosfomycin given intravenously (through a drip into a vein), used according to the national product information
Time commitment: Not stated — ask the trial team about visits, duration and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,000
- Started
- 2016-12
- Last checked
- 2024-09
Plain English Summary
What is this study?
- • Testing a new treatment for bacterial infections
- • Clinical study - 1,000 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bacterial infections
Where?
- • Bolton - Royal Bolton Hospital
- • Cottingham - Hull & East Yorkshire Hospitals NHS Trust
- • Dundee - Ninewells Hospital
- • Glasgow - Queen Elisabeth University Hospital
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Male or female patients aged ≥ 18 years
- ✓Treatment with fosfomycin according to the (national) Summary of Product Characteristics (SmPC) of fosfomycin i.v.
- ✓Written agreement to take part of the participant (or person in charge in case of patients incapable of giving consent)
Who cannot take part
- ✗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"
See the full criteria
Where Is This Study? (9 UK sites)
Royal Bolton Hospital
Bolton BL4 0JR, United Kingdom
Alison Loftus. R&D Co-ordinator
alison.loftus@boltonft.nhs.uk01204 390390 ext. 3848Hull & East Yorkshire Hospitals NHS Trust
Cottingham HU16 5JQ, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Ninewells Hospital
Dundee DD1 9SY, United Kingdom
Queen Elisabeth University Hospital
Glasgow, United Kingdom
University of Glasgow/Royal Infirmary
Glasgow, United Kingdom
University Hospital Crosshouse
Kilmarnock KA2OBB, United Kingdom
Chelsea & Westminster Hospial
London, United Kingdom
Queen Elisabeth Hospital
London, United Kingdom
Univresity College Londen (UCL) Hospital
London, United Kingdom
How to Get in Touch
Thomas Borrmann, Dr.
Sponsor contactCONTACT
Katja Eifert
Sponsor contactCONTACT