CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia) (CiproPAL)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2031
  • participants needed
    1052
  • sponsor
    University College, London
Updated on 4 October 2022

Summary

CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims:

  1. To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic Leukaemia within the ALLTogether-1 Trial.
  2. To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.

Description

This is a multi-centre randomised trial of prophylactic ciprofloxacin (10mg/kg BD, enteral/IV) versus standard of care during the neutropenic period of induction (with an internal pilot study) in patients aged 1-17 years with de-novo ALL treated on ALLTogether-1. Exclusion criteria include: patients with Down syndrome (who already receive ciprofloxacin prophylaxis), contraindication to fluoroquinolones, non-consent to ALLTogether-1 or CiproPAL. AMR of colonising organisms will be assessed with stool or peri-rectal swab cultures performed at five timepoints within the first year. Longer term invasive infection AMR monitoring will include sensitivity testing of all organisms isolated in confirmed infection for the duration of ALLTogether-1.

The primary outcome is the rate of sterile site bacterial infections during induction, evaluated by intention to treat analysis. Secondary outcomes include rates of febrile episodes, febrile neutropenia, severe infection and infection-related death; rates of AMR; antibiotic exposure; secondary infections; and quinolone side effects. A model-based health economic analysis will be undertaken. Using a conservative effect estimate of 40% reduction in bacteraemia (i.e. a reduction from 15% to 9%) 1052 patients randomised 1:1 gives 85% power with a 5% 2-sided alpha.

Details
Condition Acute Lymphoblastic Leukaemia - Category
Treatment Ciprofloxacin, Antibiotic
Clinical Study IdentifierNCT04678869
SponsorUniversity College, London
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on ALLTogether-1 in the UK in the first 5 days of therapy
Written informed consent

Exclusion Criteria

Non-participants of the ALLTogether-1 trial
Patients with Down syndrome who already receive ciprofloxacin prophylaxis
Chronic active arthritis
Other contraindication to fluoroquinolones
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