"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial looking at teicoplanin to treat infection in children's long lines (SC 1999 01)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at different ways of using teicoplanin to treat infections in children’s long lines.
This trial is for children from 2 months old and young people. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.
You may have a long line as part of your treatment for cancer or blood disorder. The advantage of a long line is that you can have chemotherapy through it and blood samples taken, without having injections or needles.
The line can stay in place for many months. But there is a risk that it may become infected with bacteria. We all have bacteria on our skin and this is usually harmless. When a person has a long line, the bacteria can enter it and get into the blood stream. This can cause an infection called septicaemia and you become very unwell as a result.
Teicoplanin is an
- Teicoplanin as a bolus injection, or
- Teicoplanin treatment over a longer period of time
The results of the 2 groups will be compared to find out which is the best way to treat septicaemia.
Who can enter
You can enter this trial if you
- Are having chemotherapy for cancer OR
- Are having treatment for one of the following non cancerous conditions - aplastic anaemia, Fanconi’s anaemia, Langerhans' Cell Histiocytosis (LCH) or myelodysplasia
- Have a long line that is expected to stay in place for at least 2 months
- Have a single or double lumen long line (a double lumen line means that it has 2 tubes or routes within the line)
- Are aged at least 2 months old
You cannot enter this trial if you
- Have had an infection in your long line with a bacteria called coagulase-negative staphylococci within the last 3 months
- Have a triple lumen long line (this means that there are 3 tubes or routes within the line)
- Cannot have a full dose of teicoplanin due to kidney problems
This trial aims to recruit between 200 to 340 children across the UK. If you take part, you join the trial about a week after having your long line put in.
There are two treatment groups in this trial. The trial is randomised. This means that you are put into the different treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
If you are in group 1 and you develop an infection, you have an injection of teicoplanin into your long line that is flushed straight into the blood stream. This will take about 5 minutes and it is called a bolus injection. At the moment, this is the standard way of using teicoplanin.
If you are in group 2 and you develop an infection, you have treatment with teicoplanin over a longer period of time. For your first dose of teicoplanin, you will have this as an infusion through your line (and into the blood stream) over a couple of hours.
For further doses of antibiotics, you either have teicoplanin
- As an infusion through the line over a couple of hours
- As an injection which is left in the line for several hours, before flushing it into the blood stream, this is called ‘locking the antibiotic into the line
Your doctor will decide which way you should have your antibiotics - as an infusion or locking the antibiotic into the line. This decision will depend on your individual circumstances.
Both groups will have teicoplanin every 12 hours for the first 3 doses, then every day for 7 days.
For the purposes of this trial, the doctors will collect information about your infection and its treatment for about 2 months. Your tests and treatment for cancer or blood disorder will continue as normal, whether you take part in this trial or not.
You will be in hospital on and off for some months, depending on your individual circumstances. You will not have extra hospital visits as a result of taking part in this trial.
If you have a bolus injection (group 1) or have teicoplanin locked into your line (some children in group 2), you may be able to have this at home. Arrangements will be made for a nurse to visit your home to give the antibiotics.
If you have an infusion (some children in group 2), you have this while you are an inpatient in hospital.
The side effects of teicoplanin are usually mild. The commonest side effect is a rash, which happens shortly after having the drug. Your doctor can easily treat this, if it happens. There are more serious side effects, which are less common. Your doctor will explain these to you in detail.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr A. McCarthy
Dr M. Millar
Professor B Pizer
Children's Cancer and Leukaemia Group (CCLG)
NIHR Clinical Research Network: Cancer