CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

NCT04678869 | Active Not Recruiting DMC

• 1 other identifier: CiproPAL (129038)
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 14

Brief Summary

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

1. 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. 2.To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.

Conditions

Acute Lymphoblastic Leukaemia - Category

Keywords

antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• rate of sterile site bacterial infections during 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 Outcomes (7)

• 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

  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

  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)

  Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)

• rates of antibiotic exposure

  during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)

Study Arms (2)

Cirprofloxacin prophylaxis

EXPERIMENTAL

prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)

Drug: Ciprofloxacin

Standard of care

ACTIVE COMPARATOR

standard of care

Drug: Antibiotic

Interventions

Ciprofloxacin DRUG

prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)

Cirprofloxacin prophylaxis

Antibiotic DRUG

Standard of care antibiotic as per local policy

Standard of care

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (14)

Royal Aberdeen Children's Hospital

Aberdeen, United Kingdom

Location

Bristol Royal Hospital for Children

Bristol, United Kingdom

Location

Addenbrookes Hospital

Cambridge, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

Leicester Royal Infirmary

Leicester, United Kingdom

Location

Alder Hey Children's Hospital

Liverpool, United Kingdom

Location

Great Ormond Street Hospital

London, United Kingdom

Location

Univeristy College Hospital London

London, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

Nottingham Children's Hospital

Nottingham, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

MeSH Terms

Interventions

Ciprofloxacin; Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Robert Phillips

  University of York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 22, 2020
• Study Start: June 29, 2022
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Access Criteria: See UCL CTC website

Locations

GB (14)