CompletedNot ApplicableInterventional

Inhale work package 3 – rapid versus standard testing to diagnose lung infections in intensive care, including COVID-19 observational sub-study

People in intensive care units (ICU) are at high risk of catching chest infections like pneumonia. Finding out which germ is causing the illness usually takes two to three days in a hospital laboratory. While waiting, doctors must treat patients quickly with general antibiotics. This means many patients receive medicines they do not need, which can cause side effects and lead to antibiotic resistance. The INHALE study tests a rapid testing machine called the Biofire FilmArray. It checks spit and phlegm samples from the lungs and gives results in about eight hours. Researchers want to see if quick results help doctors choose the most effective, targeted treatment straight away. Every participant still receives all standard hospital care, and their samples are still sent to the main laboratory, ensuring their treatment remains safe and thorough.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

University College London

Enrolment target

552

Start

01 Jul 2019

Estimated completion

31 Oct 2021

Pneumonia

What is this study about?

When someone is severely ill in an intensive care unit (ICU), their lungs are very vulnerable. Chest infections like hospital-acquired pneumonia can develop quickly and become life-threatening. Doctors must act straight away, so they immediately start patients on broad-spectrum antibiotics to fight a wide range of bacteria. At the same time, they send a sample of phlegm (mucus from the airways) to the hospital laboratory to identify the exact germ.

The problem is that standard laboratory tests take two to three days to grow and identify the bacteria. During this waiting time, around two out of three patients receive antibiotics that they might not actually need. Overusing antibiotics can cause unpleasant side effects and teaches bacteria how to survive treatments. This creates 'drug-resistant' bugs, which is a major health concern for the NHS and hospitals worldwide.

The INHALE trial is looking at whether a rapid diagnostic machine can solve this problem. The machine tests phlegm right away and provides results within eight hours. This lets doctors know much sooner which germ is present and which specific antibiotic will work best. The study also looks at how this rapid test can help care for intensive care patients with COVID-19 who develop secondary chest infections.

Taking part does not replace standard care. Every patient still has their phlegm sent for normal lab testing as well. This gives the medical team the speed of the new machine alongside the safety and backup of traditional testing.

Key takeaways

Tests a rapid machine that identifies pneumonia germs in eight hours rather than two to three days.
Aims to help doctors prescribe the right antibiotics faster and avoid unnecessary medication.
Designed for adults and children being treated in intensive care units.
Does not test new drugs; standard NHS antibiotics and laboratory testing continue as normal.
Participation requires no extra procedures beyond collecting routine phlegm samples.

Who may be eligible?

This study is for patients being treated in an intensive care unit (ICU) or critical care unit (CCU) who have been in hospital for at least 48 hours. They must have a suspected chest infection, such as hospital-acquired pneumonia, that needs new or changed antibiotic treatment. Patients can be breathing on their own or using a mechanical ventilator.

To be included, the patient must be able to provide enough phlegm or airway fluid for both normal hospital lab tests and the new rapid test. Only a very small amount of fluid is needed for the machine.

People cannot take part if they are already taking part in another clinical trial testing a new medical treatment, if they have an agreed directive to withhold life-sustaining care, if they are not expected to survive the next 48 hours, or if they are in the care of the prison service.

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.

Currently staying in an intensive care unit (ICU) or critical care unit (CCU)
Has been in the hospital for more than 48 hours
Has a suspected severe chest infection or pneumonia needing antibiotics
Able to provide a phlegm or airway fluid sample
Not receiving end-of-life care and expected to survive beyond the next 48 hours

Answer every question to see your result.

What does participation involve?

Because participants are already being treated in intensive care, taking part does not require any extra clinic visits or travel. As part of normal care, doctors and nurses collect a small sample of phlegm from the patient's breathing tubes or chest. For this study, a tiny extra drop of that fluid is placed into the rapid testing machine on the ward.

Results from the machine are reviewed within eight hours. Doctors can then adjust the patient's antibiotics according to expert hospital guidelines. The patient's care continues as normal, and the standard laboratory tests are run alongside the rapid test. Medical staff monitor the patient's recovery throughout their hospital stay. Once the patient recovers or leaves intensive care, basic health information from their hospital charts is collected anonymously to evaluate how well the test worked.

Potential risks and benefits

There is no guarantee of personal benefit, but having faster test results may help the medical team choose the best antibiotic for the patient much sooner, potentially reducing unnecessary medication. The study also helps the NHS learn how to treat pneumonia more safely and prevent antibiotic resistance in the future. The physical risks are very low because no experimental medicines are being given, and phlegm samples are already taken as part of standard care. The rapid machine tests for the most common germs, but it could miss a rare one; however, because all samples are also sent to the standard laboratory, any rare bacteria will still be spotted within a few days. Participation is entirely voluntary, and families or patients can choose to stop taking part at any time without altering their standard NHS medical care.

Locations (13)

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

University College London Hospitals NHS Foundation Trust
Unverified
London, England
Aintree Hospital
Unverified
Liverpool, England
Chelsea and Westminster Hospital NHS Foundation Trust
Unverified
London, England
Russells Hall Hospital
Unverified
Dudley, England
Great Ormond Street Hospital
Unverified
London, England
James Paget University Hospitals Nhs Foundation Trust
Unverified
Great Yarmouth, England
Royal Free Hospital
Unverified
London, England
Royal Liverpool University Hospital
Unverified
Liverpool, England
Staffordshire and Stoke on Trent Partnership NHS Trust
Unverified
Stoke on Trent, England
BUPA Cromwell Hospital
Unverified
London, England
Birmingham Children's Hospital
Unverified
Birmingham, England
Watford General Hospital
Unverified
Watford, England

Common questions

Will taking part cause any extra pain or discomfort?

No. The study uses a tiny amount of phlegm that the nursing team is already collecting as part of normal intensive care. No extra needles or painful procedures are needed.

Is the patient being given an experimental drug?

No. The trial is only testing a diagnostic machine. All medicines given are approved NHS antibiotics prescribed by the patient's regular doctor.

What happens if the rapid machine misses a germ?

The machine looks for the most common causes of pneumonia. Because every sample is still sent to the standard hospital lab, any rare bacteria that the machine misses will be caught by the regular lab test within two to three days.

Can someone take part if they are unconscious?

Yes. In intensive care, patients are often too unwell to give consent themselves. In these cases, researchers consult family members or follow strict legal and ethical guidelines to act in the patient's best interests.

Can a patient leave the study if they change their mind?

Yes. Taking part is completely voluntary. The patient or their family can withdraw from the study at any time, and it will not affect the quality of their normal hospital care.

How to find out more

Vicky Enne

inhale.study@uea.ac.uk 442076792000 Official trial record

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