CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
Research type
Research Study
Full title
A randomised trial to assess the use of ciprofloxacin prophylaxis to prevent bacterial infection in children treated on the induction phase of the ALLTogether1 treatment protocol
IRAS ID
1004004
Contact name
Robert Phillips
Contact email
Sponsor organisation
University College London
Eudract number
2021-000341-40
ISRCTN Number
ISRCTN21195635
Clinicaltrials.gov Identifier
Research summary
Acute Lymphoblastic Leukaemia (ALL) is one of the commonest forms of childhood cancer. It is a cancer of the infection fighting cells in the body, the white blood cells. Healthy blood cells are not produced, so they do not work properly, putting the child at increased risk of having an infection. The treatment for ALL involves chemotherapy which reduces the child's ability to fight infections.
Infection is now one of the commonest causes of death in children with ALL, and this is most likely to happen in the first five weeks of treatment which is called the induction phase.
In children with acute myeloid leukaemia or relapsed ALL, trials showed that giving a prophylactic daily, low dose of antibiotics every day can reduce the risk of infection by about a half. No similar trial has been carried out in children having their first treatment for ALL. With the opening of ALLTogether1, a new research study looking at how best to treat children with new ALL, there is a unique opportunity to work alongside the study in the UK to cost-effectively study the use of prophylactic fluoroquinolone antibiotics in this population.CiproPAL aims to assess if adding a daily, low-dose antibiotic (called ciprofloxacin) during the induction phase of the ALLTogether1 trial will reduce the risk of infection in children aged 1-17 years old.
Each child who takes part in CiproPAL will receive either the antibiotic (ciprofloxacin) or no antibiotic, this will be randomly allocated. Infections on each child will be monitored and assessed. As giving children regular antibiotics might change how well the infections respond to antibiotics in the future (“resistance”), tests will be carried out to see if the infections that make children unwell are more resistant to antibiotics, and whether the bacteria that usually live in us are more resistant to antibiotics. This will help decide whether using ciprofloxacin is beneficial.REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0752
Date of REC Opinion
25 Nov 2021
REC opinion
Further Information Favourable Opinion