CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia) (CiproPAL)

March 3, 2026 updated by: University College, London

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia): A Randomised Trial to Assess the Use of Ciprofloxacin Prophylaxis to Prevent Bacterial Infection in Children Treated on the Induction Phase of the ALLTogether-1 Treatment Protocol

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom
        • Royal Aberdeen Children's Hospital
      • Bristol, United Kingdom
        • Bristol Royal Hospital for Children
      • Cambridge, United Kingdom
        • Addenbrookes Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Leicester, United Kingdom
        • Leicester Royal Infirmary
      • Liverpool, United Kingdom
        • Alder Hey Children's Hospital
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • Univeristy College Hospital London
      • Manchester, United Kingdom
        • Royal Manchester Children's Hospital
      • Newcastle, United Kingdom
        • Royal Victoria Infirmary
      • Nottingham, United Kingdom
        • Nottingham Children's Hospital
      • Oxford, United Kingdom
        • John Radcliffe Hospital
      • Sheffield, United Kingdom
        • Sheffield Children's Hospital
      • Southampton, United Kingdom
        • Southampton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Description

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, up to 14 days is acceptable.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cirprofloxacin prophylaxis
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Drug: Ciprofloxacin
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Active Comparator: Standard of care
standard of care
Drug: Antibiotic
Standard of care antibiotic as per local policy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
rate of sterile site bacterial infections during induction
during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 episodes
during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
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 febrile neutropenia
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
Time Frame: during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
severe infection rates and deaths from infection
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)
Time Frame: Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
rates of AMR
Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
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 antibiotic exposure
during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
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)
rates of secondary infections
during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
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)
quinolone side effects
during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: Robert Phillips, University of York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2022

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 5, 2020

First Submitted That Met QC Criteria

December 16, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CiproPAL (129038)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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)

IPD Sharing Access Criteria

See UCL CTC website

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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