PEPtalk 2
Research type
Research Study
Full title
PEPtalk 2: Pilot of a randomised controlled trial to compare VZIG and aciclovir as post-exposure prophylaxis against chickenpox in children with cancer
IRAS ID
98674
Contact name
Paul Heath
Contact email
Eudract number
2013-001332-22
ISRCTN Number
ISRCTN48257441
Clinicaltrials.gov Identifier
UoB CRCTU CAS Code, XX2001
Duration of Study in the UK
1 years, 7 months, 23 days
Research summary
Treatment for cancer in children often includes the use of anti-cancer drugs called chemotherapy. Some chemotherapy drugs can reduce the production of white blood cells, which lowers a child's immunity. This means that some infections that are usually mild in healthy children can be more difficult for a child with cancer to cope with. Chickenpox is one of these infections and it can be life-threatening for a child with cancer.
It is therefore important to try to prevent children with cancer from developing chickenpox. If a child with cancer has close contact with someone who is infectious for chickenpox, they are usually offered preventative medicine. This is called post-exposure prophylaxis (PEP). There are two different types of PEP used in the UK and medical opinion is divided over which is better. So about half of children receive VZIG, an injection of chickenpox antibodies into the muscle, while the other half of children receive aciclovir, an orally administered course of antiviral medicine.
This pilot trial aims to prepare for a main Phase III trial, the aim of which will be to find out whether aciclovir is at least as good as VZIG in protecting against chickenpox in children with cancer. This pilot study will help to inform a sample size calculation; it will test the components of the larger study; and it will test how acceptable the trial procedures are to parents, patients and clinicians. A secondary aim is to establish whether these two treatments have different costs to the health service and the effects on patients’ quality of life. A health economic analysis will be performed accordingly.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/0551
Date of REC Opinion
14 May 2013
REC opinion
Favourable Opinion