An interventional study of Ciprofloxacin and Antibiotic in Acute Lymphoblastic Leukaemia - Category, sponsored by University College, London. Active, not recruiting at 14 sites in United Kingdom. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-03-05.
Sponsored by University College, London · Not applicable, Interventional, and Supportive care
CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims:
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.
University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Drug: Ciprofloxacin
standard of care
Drug: Antibiotic
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Standard of care antibiotic as per local policy
rate of sterile site bacterial infections during induction
rate of sterile site bacterial infections during induction
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of febrile episodes
rates of febrile episodes
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of febrile neutropenia
rates of febrile neutropenia
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of severe infection and infection-related death
severe infection rates and deaths from infection
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of AMR (antimicrobial resistance)
rates of AMR
Time frame: Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
rates of antibiotic exposure
rates of antibiotic exposure
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
rates of secondary infections
rates of secondary infections
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
quinolone side effects
quinolone side effects
Time frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Plan to share: Yes — Requests for de-identified data should be made in writing to the relevant trials group lead at the CR UK and UCL Cancer Trials Centre (https://www.ctc.ucl.ac.uk/DataSampleSharing.aspx)
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University College, London