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 (CiproPAL)

Research summary

CiproPAL is a randomised,open-label trial in paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on the existing ALLTogether-1 study (EudraCT 2018-001795-38,REC ref 20/LO/0848,Sponsor: Karolinska University) in the UK. The two main aims of the CiproPAL trial are: 1. To assess the efficacy of ciprofloxacin prophylaxis in reducing infections during the induction phase of the ALLTogether1 Trial. 2. To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance,both in terms of invasive infections and colonising organisms. Patients will be randomised (1:1) to one of two arms; the interventional arm will receive prophylactic ciprofloxacin (10mg/kg twice a day,enteral or intravenously) from randomisation to the end of induction. Those randomised to the control arm will receive no additional treatment during induction and will receive the standard of care as per local policy. The trial aims to recruit 1052 patients across 20 sites over 42 months. Patients will be actively followed up for 12 months,with ongoing longer-term follow-up for a minimum of 5 years,until the end of trial is declared. The end of trial will be declared when the last CiproPAL patient has completed the follow-up for ALLTogether1 (this is estimated to be December 2031).

Principal Investigator

Dr Amrana Qureshi

Contact us

Email: Paedhaem.oncresearch@ouh.nhs.uk

IRAS number

1004004