SAFE study
*Staphylococcus aureus* is a common bacterium that can cause severe illness if it enters the bloodstream, a condition known as blood poisoning or bacteremia. This requires prompt hospital care with antibiotics. The SAFE study is a Phase 3 clinical trial comparing established antibiotic treatments to see which is safest and most effective. It includes adults aged 18 and over who have this type of blood infection. Participants receive antibiotics such as flucloxacillin, cefazolin, or clindamycin, either through a drip into a vein or as capsules to swallow. Doctors will follow each patient's progress for 180 days (about six months). The main goal is to see whether patients recover fully, stay healthy, and remain free from any return of the infection in their blood or joints.
At a glance
What is this study about?
*Staphylococcus aureus* (often called 'Staph') is a germ that many people carry naturally on their skin without any problems. However, if it enters the bloodstream—such as through a cut or a hospital drip—it can cause a serious and potentially life-threatening infection called bacteremia. When this happens, patients need prompt treatment with strong antibiotics.
Doctors currently use antibiotics like flucloxacillin, cefazolin, and clindamycin to treat Staph infections. While these medicines are well-known and widely used, doctors still need clear evidence on which antibiotic or combination gives patients the best chance of a full recovery without the infection returning.
The SAFE study aims to compare these antibiotic options directly in hospital patients. By monitoring how well each medicine clears the bacteria, researchers hope to determine the most effective treatment plan to protect patients from future complications.
The findings from this study could help improve NHS guidelines, reduce the amount of time patients need to spend in hospital, and lower the risk of dangerous infections coming back.
Key takeaways
- The SAFE study compares common antibiotics to find the best treatment for Staph blood infections.
- Open to hospital patients aged 18 and older with confirmed *Staphylococcus aureus* in their blood.
- Treatments include flucloxacillin, cefazolin, and clindamycin given by drip or capsule.
- Participants are monitored for six months to ensure the infection does not return.
- Taking part is voluntary and will not change the quality of your regular NHS care.
Who may be eligible?
This study is open to adults aged 18 and over who have been admitted to hospital and diagnosed with a *Staphylococcus aureus* infection in their bloodstream. Both men and women may take part.
Because this infection requires immediate hospital care, your care team will confirm the presence of the bacteria through laboratory blood tests before discussing the trial with you.
You may not be able to join if you have known severe allergies to the study antibiotics (such as penicillin or cephalosporin antibiotics) or if you have other medical conditions that make these medicines unsuitable. Your hospital doctors will review your medical history to make sure taking part is safe for you.
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.
- I am aged 18 or older.
- I am currently in hospital with a confirmed Staph blood infection.
- I can receive antibiotics by drip or swallow capsules.
- I do not have a known severe allergy to the study antibiotics.
What does participation involve?
If you join the SAFE study, you will receive antibiotic treatment while you are in the hospital. Depending on which treatment group you are placed in, you will receive antibiotics through an intravenous drip into a vein (such as flucloxacillin or cefazolin) or as capsules to swallow (such as clindamycin).
During your stay, the medical team will carry out regular health checks and blood tests to monitor your recovery and see how well the medicine is working. After you leave the hospital, the study team will keep in touch with you for up to 180 days (about six months). They will check your symptoms, ask about your general health, and ensure the infection has not returned.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is Staphylococcus aureus bacteremia?
It is a serious medical condition where *Staphylococcus aureus* bacteria enter the bloodstream, commonly referred to as blood poisoning.
Are the study antibiotics experimental?
No. The medicines being studied (flucloxacillin, cefazolin, and clindamycin) are standard, approved antibiotics already widely used in hospitals.
How will I take the study medicine?
Depending on your assigned group, you will receive the antibiotics either through a drip into your vein or as capsules to swallow.
How long will I be in the study?
You will receive treatment during your hospital stay and will then be followed up for about 180 days (six months) to make sure you stay well.
What happens if I decide not to take part?
Joining is completely your choice. If you decide not to join, your doctors will give you standard antibiotic care as normal.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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