RecruitingNot ApplicableInterventional

A trial comparing short course antibiotics and standard course antibiotics for the treatment of sepsis

Sepsis is a life-threatening reaction to an infection that often requires care in an intensive care unit (ICU). While antibiotics are vital to treat sepsis, taking them for too long can cause kidney or liver problems, severe bowel infections, and drug-resistant superbugs. Doctors usually give antibiotics for seven to nine days or more, but shorter courses might work just as well. The SHORTER trial is comparing a five-day antibiotic course with standard care in adults with sepsis in intensive care. A computer randomly decides the treatment length. Patients receive standard care otherwise, and hospital doctors still choose which antibiotics to prescribe. Patient safety comes first: if someone needs more antibiotics, doctors give them straight away. The trial tracks patient recovery in hospital and checks in after 90 days to see if the shorter course is equally effective.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

2,244

Start

30 Nov 2023

Estimated completion

30 Jun 2027

Sepsis

What is this study about?

Sepsis happens when the body has an extreme, life-threatening response to an infection. Instead of just fighting the germs, the immune system begins damaging the body's own tissues and organs. People with sepsis often become seriously unwell very quickly and need specialised treatment on an intensive care unit (ICU) or high dependency unit (HDU).

Antibiotics are essential for curing sepsis, but using them for longer than necessary carries real risks. Extended courses can harm important organs like the kidneys and liver, trigger severe tummy upsets, and encourage bacteria to become resistant to treatments. At present, medical guidelines do not clearly show the exact number of days someone needs antibiotics for sepsis, meaning many people receive standard courses lasting a week or longer.

The SHORTER trial aims to discover if a shorter, five-day course of antibiotics works just as well as standard care. By gathering evidence from NHS hospitals, the researchers hope to show that patients can recover safely with fewer antibiotics, avoiding unnecessary side effects and helping protect life-saving medicines for the future.

Key takeaways

Tests whether five days of antibiotics works as well as standard care (seven to nine days) for sepsis.
Aimed at adults currently being treated for sepsis in an intensive care or high dependency unit.
Doctors can restart or extend antibiotics at any time if the patient needs them.
Hospital stays do not change, and follow-up is completed by a questionnaire after 90 days.
Aims to reduce medication side effects and combat antibiotic resistance.

Who may be eligible?

This study is for adults aged 18 and older who have been admitted to an intensive care or high dependency unit with suspected or confirmed sepsis. To join, a person must have started their antibiotic treatment within the last four days and show signs that an infection is affecting their organs.

The trial is not suitable for everyone. People with weakened immune systems—such as those having chemotherapy, taking high-dose steroid tablets, or recovering from an organ transplant—cannot take part. It also excludes people with very low white blood cell counts secondary to an existing health condition.

Finally, patients who need very long antibiotic treatments for specific conditions (such as heart valve or bone infections) are excluded, as are those receiving end-of-life care or whose treatment may be withdrawn in the next 24 hours.

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.

Aged 18 or older
Currently receiving care for sepsis in an intensive care or high dependency unit
Started antibiotic treatment within the past 4 days
Not currently taking immunosuppressant medicines or having chemotherapy
Does not have a complex infection needing weeks of antibiotics (like a bone or heart infection)

Answer every question to see your result.

What does participation involve?

Because patients with sepsis are often too unwell to give consent straight away, study doctors may consult family members or follow standard emergency research rules to enrol them. A computer randomly assigns the patient to either a short five-day course of antibiotics or standard care (usually around seven to nine days). The hospital medical team chooses which specific antibiotics are used. No extra hospital visits are needed, as research staff collect all health details directly from medical records during the hospital stay. Around 90 days (three months) after joining, the patient or their family will be contacted to answer a short health questionnaire.

Potential risks and benefits

Participants might benefit from having fewer antibiotic side effects, such as lower risks of bowel infections or organ strain, though individual benefit cannot be guaranteed. The findings will help improve future NHS care for sepsis. The main risk is that five days might not be enough to clear the infection. However, the patient's doctors monitor them around the clock; if there is any sign that an infection has not cleared, the doctor will restart or lengthen the antibiotic course immediately. Taking part is completely voluntary, and a patient or their representative can withdraw at any point without it affecting standard medical care.

Locations (60)

The Whittington Hospital
Approximate
London, England
Kings College Hospital
Approximate
London, England
Princess Royal University Hospital
Approximate
Orpington, England
Ipswich Hospital
Approximate
Ipswich, England
Freeman Hospital
Approximate
Newcastle upon Tyne, England
Royal Victoria Infirmary
Unverified
Newcastle upon Tyne, England
Royal Papworth Hospital
Unverified
Cambridge, England
Sunderland Royal Hospital
Unverified
Sunderland, England
Northumbria Specialist Emergency Care Hospital
Unverified
Cramlington, England
Milton Keynes General Hospital
Unverified
Milton Keynes, England
Queens Hospital
Unverified
Romford, England
Northampton General Hospital
Unverified
Northampton, England

Common questions

Will taking part change which antibiotics are given?

No. The hospital doctors still choose the exact antibiotic medicine they believe is best. The study only guides how many days the medicine is given.

What happens if a patient gets worse after stopping antibiotics on day five?

Patient safety always comes first. If a patient shows signs of needing more treatment, their medical team will restart antibiotics without hesitation.

Do participants need to stay in hospital for 90 days?

No. The hospital stay depends entirely on how quickly the patient recovers. The 90 days refers to the total follow-up period, which ends with a simple questionnaire completed from home.

Can someone leave the trial if they change their mind?

Yes. Patients or their representatives can withdraw from the study at any time. Normal NHS treatment will continue as usual.

Who is organising and funding this research?

The trial is run by Newcastle upon Tyne Hospitals NHS Foundation Trust and funded by the National Institute for Health and Care Research (NIHR).

How to find out more

Zoe Walmsley

SHORTER.Trial@newcastle.ac.uk +44 191 208 3819 Official trial record

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