RecruitingOBSERVATIONAL

Fosfomycin I.v. for Treatment of Severely Infected Patients

This study is gathering information on an antibiotic called fosfomycin. Doctors use fosfomycin to treat serious bacterial infections in different parts of the body, such as bone infections (osteomyelitis), infections of the brain and spinal cord (meningitis), severe lung infections (pneumonia), and blood infections (sepsis). The study aims to understand how well fosfomycin works and if it's safe when given through a drip (intravenously) to adults who are already very ill with these types of infections. It's what's called a 'non-interventional' study, meaning that everyone in the study will be receiving fosfomycin as part of their normal care, rather than as an experimental treatment. This helps researchers learn more about how the medication performs in everyday medical practice across different European hospitals.

At a glance

Status

Recruiting

Sponsor

Infectopharm Arzneimittel GmbH

Enrolment target

1,000

Start

01 Dec 2016

Estimated completion

01 Dec 2030

Bacterial Infections Bone Diseases, Infectious Osteomyelitis Central Nervous System Bacterial Infections Meningitis, Bacterial Encephalitis Brain Abscess Urinary Tract Infections Respiratory Tract Infections Pneumonia, Bacterial Skin Diseases, Bacterial Soft Tissue Infections Intraabdominal Infections Sepsis Bacteremia Endocarditis, Bacterial

What is this study about?

This study is all about understanding how an antibiotic called fosfomycin works when it's given to people who are very unwell with serious bacterial infections. Fosfomycin is a medicine that doctors use to fight off harmful bacteria in the body. It’s given directly into a vein through a drip, which means it gets into the body quickly to start fighting the infection.

The study is designed to observe how patients are treated with fosfomycin in hospitals across Europe. It’s not a trial where people get new, experimental treatments; instead, it looks at how fosfomycin is used in real life for many different kinds of severe infections. These can include infections that affect the bones, like osteomyelitis; serious infections of the brain and spinal cord, like meningitis; severe lung infections such as pneumonia; and infections that get into the bloodstream, known as sepsis.

By gathering information from many hospitals, researchers hope to get a clearer picture of how effective fosfomycin is at treating these tough infections and what its safety profile looks like when used in a wide range of patients. This kind of information helps doctors make the best treatment choices in the future, ensuring patients get the most appropriate care for their infections.

Key takeaways

The study observes how fosfomycin is used for serious bacterial infections.
It's for adults already being treated with fosfomycin through a drip.
No extra treatments or procedures are involved for participants.
Information about your treatment and recovery will be collected from your medical records.
The study aims to improve understanding of fosfomycin's effectiveness and safety in real-world settings.

Who may be eligible?

Doctors are looking for adult patients, aged 18 or older, who are already receiving fosfomycin through a drip for a serious bacterial infection. This might include infections affecting your bones, bladder, lungs (especially if caught in hospital), brain, bloodstream, skin, or heart lining. You'd need to agree to be part of the study, or if you're too unwell, a family member or someone responsible for your care would need to give permission.

You wouldn't be able to join if you've already been part of this specific study before, or if you're taking part in another type of medical trial that involves experimental treatments. Also, if you know you're allergic to fosfomycin or any of its ingredients, this study wouldn't be suitable for you. The study also isn't for those who are terminally ill, have a 'do not resuscitate' order, or are only receiving comfort care (palliative treatment).

Other reasons you might not be able to join include if several of your main body systems (like your lungs, heart, or kidneys) are failing, if you have advanced HIV/AIDS, if fosfomycin is being used as a very last resort after many other treatments have failed, or if your infection is caused by fungi or certain other germs, not just bacteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you currently receiving fosfomycin through a drip for a severe bacterial infection?
Do you have one of the listed infections (e.g., bone infection, meningitis, severe pneumonia)?
Have you *not* had a serious allergic reaction to fosfomycin before?
Are you *not* already in another medical study using experimental treatments?
Are you willing for your anonymised medical information to be used for this research?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't be doing anything different from what your medical team already planned for your treatment. You'll receive fosfomycin through a drip as per your doctor's usual practice for your infection. The study won't ask you to visit extra clinics or have additional tests specifically for the study. Instead, the doctors and nurses will simply collect information from your medical records about your infection, your fosfomycin treatment, how you respond to it, and any side effects you might experience. This information will be gathered during your hospital stay and any follow-up appointments already scheduled for your care. There are no extra medications or follow-up visits beyond what your doctor would normally recommend for your condition.

Potential risks and benefits

There are no direct personal benefits from taking part in this study, as you'd be receiving the same treatment whether you participated or not. However, the information gathered could help doctors better understand how fosfomycin works for severe infections, potentially benefiting future patients. Since you'll be receiving fosfomycin as part of your standard medical care, any risks are related to the treatment itself, which your doctor will discuss with you. Taking part in the study simply means your medical information is collected, and there are no additional treatments or procedures. You are free to withdraw your consent at any time without affecting your medical care.

Locations (50)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Landeskrankenhaus Hall - Tirol Kliniken
Verified postcode
Hall in Tirol, Austria· Recruiting
A.ö. Bezirkskrankenhaus
Verified postcode
Reutte, Austria· Recruiting
AKH Wien, Universitätsklinik für Innere Medizin 1
Verified postcode
Vienna, Austria· Recruiting
Klinikum Wels-Grieskirchen, Institut für Hygiene und Mikrobiologie
Verified postcode
Wels, Austria· Recruiting
Universitätsmedizin Charité
Verified postcode
Berlin, Germany· Completed
Vivantes Kliniken Neukölln
Verified postcode
Berlin, Germany· Recruiting
Städtisches Klinikum Braunschweig
Verified postcode
Braunschweig, Germany· Recruiting
Universitäts Düsseldorf; Klinik für Anästhesiologie
Verified postcode
Düsseldorf, Germany· Completed
Universitätsklinikum Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
Universität Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
Universitätsklinikum Jena; Zentrum für Infektionsmedizin
Verified postcode
Jena, Germany· Recruiting
Universitätsklinikum Schleswig-Holstein
Verified postcode
Kiel, Germany· Recruiting

Common questions

What is fosfomycin?

Fosfomycin is an antibiotic, a medicine used to kill bacteria that cause infections.

Is this a new medicine?

No, fosfomycin is an established antibiotic. This study is observing how it's used in real situations.

Will I get extra tests if I join?

No, you won't have any extra tests or appointments just for this study. All information comes from your routine medical care.

What kind of infections are included?

The study looks at severe bacterial infections like bone infections, meningitis, pneumonia, and blood infections, among others.

Can I stop being part of the study?

Yes, you can decide to stop being part of the study at any time, and it won't affect your medical care.

How to find out more

Thomas Borrmann, Dr.

clinical.trials@infectopharm.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.