A trial looking at 2 new tests to diagnose a fungal infection

This trial is looking at 2 tests to see if they can help doctors diagnose aspergillosis, a fungal infection.

Aspergillosis is a lung infection caused by aspergillus, a type of fungus. People who have a low white blood cell count after intensive chemotherapy or a stem cell transplant are at higher risk of infections, including aspergillosis. Aspergillosis can be difficult and expensive to treat, and the treatments available have serious side effects.

To diagnose aspergillosis for sure, doctors currently need to take some tissue or fluid from the lung during a bronchoscopy. This is invasive and has risks, especially in very unwell patients. Because of this, some high risk patients have treatment for aspergillosis without having a test to diagnose it, just in case they have the infection. But they may not need this treatment, so some people go through side effects for no reason.

The research team want to find out if 2 new tests can diagnose aspergillosis more quickly and easily. One is a blood sample that can be tested for parts of fungal cells that are released during an infection. The other is a breathing test that collects moisture from the lungs as you breathe out. This is called exhaled breath condensate (EBC). The moisture they collect is then tested for signs of fungal infection.

The aims of this trial are to find out

How good the new blood test is at diagnosing aspergillosis
How good the EBC test is at diagnosing aspergillosis
If diagnosing aspergillosis with these new tests means that only the people who need it will have treatment

Recruitment

Start 01/07/2005

End 01/12/2010

Phase

Other

Who can enter

You can enter this trial if you

Have acute myeloid leukaemia (AML), acute lymphocytic leukaemia (ALL) or myelodysplastic syndrome (MDS)
Are at least 18 years old

As well as that, you must fit one of the following. You

Are having intensive chemotherapy or high dose steroids, or both, or
Are having a transplant using someone else’s stem cells rather than your own (an allogeneic stem cell transplant), or
Are taking high dose steroids as part of treatment for graft versus host disease (GVHD) or
Have had (or are thought to have had) aspergillosis in the past

You cannot enter this trial if you already have a medical condition that affects your lungs.

Trial design

This trial will recruit between 150 and 200 people. Everyone taking part will have both new tests. Some people will take part more than once, because you can join the trial again after each cycle of chemotherapy.

You have the blood test twice a week if you are an in patient, or once a week if you are an out patient, for up to 8 weeks. You will have frequent blood tests as part of your routine care, so they just need to take a small amount of extra blood for the new test.

At the same time, you will do the exhaled breath condensate (EBC) test once a week for 5 weeks. For this test you need to breath out through a cold tube for 15 to 20 minutes. The cold tube makes the moisture in your breath condense so the research team can collect and test it.

If you develop a fever at any stage during the trial, you will have more tests to look for an infection. This may include blood tests, a chest X-ray, CT scan or taking a sample of fluid and cells during a bronchoscopy (a bronchial lavage). If you have an infection you will have appropriate treatment as usual.

Hospital visits

You will have a physical examination, blood tests and EBC as part of this trial. But these are all done during routine hospital visits or while you are having other tests. You won’t need to make any extra trips to the hospital as a result of taking part in this trial.

You will see the trial doctors once a week for 8 weeks, or less if your white blood cell count goes back up to normal range sooner. After that you will continue to see your own doctor.