27 March 2012
Clinical trial to test success of Cystic Fibrosis lung infection treatment
Experts from Bristol and Nottingham are leading a major new
national study to investigate whether intravenous antibiotics are
effective in killing a common germ that causes dangerous
complications in cystic fibrosis (CF) patients.
The team is hoping to find out if the treatment is more
effective than traditional therapies in tackling Pseudomonas
aeruginosa, which causes a chronic destructive lung infection in CF
patients and which cannot be eradicated unless it is caught in the
Dr Simon Langton Hewer, from University Hospitals Bristol NHS
Foundation Trust, who is chief investigator of the study, said:
"It's very exciting to have a clinical trial available to CF
patients around the whole of the UK. This is the first CF trial for
many years to be run in the UK and will answer one of the important
questions affecting CF patients."
Professor Alan Smyth in the University of Nottingham's School of
Clinical Sciences, a co-investigator in the TORPEDO clinical trial,
said: "Children and adults with CF are now receiving intravenous
antibiotics for Pseudomonas more and more often, with no good
evidence that this is more effective. We want to see if intravenous
antibiotics do work better than traditional oral treatment because
oral treatment is easier to give at home and does not require a
Pseudomonas aeruginosa is a bacterium that lives in the
environment, lurking in places such as sink drains. Most CF
patients have chronic lung infection with the germ by their late
teens. Oral and nebulised (inhaled) antibiotics have mainly been
used to eradicate Pseudomonas, but are often only effective if the
infection is caught in time.
Intravenous antibiotics are being used more often to treat the
infection, however, there is no current clear scientific evidence
that intravenous treatment is better than oral treatments.
Intravenous treatment means that patients with CF need to spend up
to two weeks in hospital in addition to the medication they may
previously have been prescribed.
The new trial is funded with £1.5 million from the National
Institute for Health Research (NIHR) Health Technology Assessment
(HTA) programme and sponsored by University Hospitals Bristol NHS
So far, 41 CF centres and clinics around the UK have signed up
to the trial - coordinated from the Medicines for Children Research
Network (MCRN) Clinical Trials Unit in Liverpool - with the aim of
recruiting 280 volunteer CF patients.
Adele Whitford from Severn Beach near Bristol, whose daughter
has cystic fibrosis, said: "We decided to take part in the trial
because we want to help improve the care for cystic fibrosis
patients. As a nurse, part of my job is to provide best evidence
practice and without research being carried out you haven't got
Zoë and Steve Elliott, of Mapperley Park, Nottingham, have
two-year-old twins Alexander and Isobel who were both diagnosed
with CF shortly after they were born. They say they didn't hesitate
in getting the twins involved with the trial and hope the research
will give parents of children with CF firm evidence of whether IV
antibiotics really do offer the best treatment option.
Zoë said: "When we were invited on to the trial I was initially
really surprised that this research hadn't already been done
because in our experience IV antibiotics are generally perceived
among parents of children with CF to be the best way of eradicating
the infection. As a mum, if it's a toss-up between being at home
with a nebuliser for three months or having your child in hospital
having invasive treatment for two weeks I know what my gut instinct
tells me - it's home every time. But it would be reassuring to have
some firm evidence to allow us to make a more informed choice and
that's why this research is long overdue."
Matthew Reed, Chief Executive of the Cystic Fibrosis Trust said:
"Pseudomonas infection is a leading cause of lung damage in people
with CF so it is important to find the most effective way to
eradicate this bug and therefore help people with CF to live
longer. We commend the team at Nottingham and Bristol for their
initiative on this study and hope that suitable people with CF
throughout the UK will agree to take part in this important piece
of research. It is great to see so many UK CF centres (large and
small) involved and we would encourage centres not yet taking part
to sign up for the trial."
Patients with a new Pseudomonas aeruginosa infection which has
been identified through a routine sample from the lungs are being
invited on to the study and are given (at random) either two weeks
of intravenous antibiotics and three months of nebulised
antibiotics or three months of combined oral and nebulised
treatment. They will then be followed up for a further 15 months
through routine clinic visits to assess whether the germ has been
eradicated and stays away for at least a year.
If the trial finds that intravenous antibiotics are more
successful in treating the infection, this will form the basis of
national guidelines on standard medical practice and mean that
patients have access to a more effective treatment.
If intravenous treatment doesn't work as well as traditional
methods, it could spare patients the inconvenience of
hospitalisation, the trauma of having an intravenous cannula
inserted - a particular problem for many children suffering from CF
- and the upset of missing school or work for two weeks.
The trial is open to adults and children with CF (excluding
babies under one month old) and further information about the trial
and how to participate can be found at http://www.torpedo-cf.org.uk/index.html
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