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NCT04678869 Clinical Trial

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

Acute Lymphoblastic Leukaemia - Category Clinical Trial

— CiproPAL  

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04678869
Other study ID # CiproPAL (129038)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 29, 2022
Est. completion date December 31, 2031

Study information
Verified date March 2024
Source University College, London
Contact Stephanie Argue
Phone 02076799860
Email ctc.cipropal@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1052
Est. completion date December 31, 2031
Est. primary completion date December 1, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Acute Lymphoblastic Leukaemia - Category
  • Leukemia
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• Ciprofloxacin
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
• Antibiotic
Standard of care antibiotic as per local policy

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

Sponsors (2)
Lead Sponsor Collaborator
University College, London National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 rates of febrile episodes rates of febrile episodes during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Secondary rates of febrile neutropenia rates of febrile neutropenia during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Secondary rates of severe infection and infection-related death 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)
Secondary rates of AMR (antimicrobial resistance) rates of AMR Until the end of trial approx 10 years (from randomisation until the end of trial declaration in 2031)
Secondary rates of antibiotic exposure rates of antibiotic exposure during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Secondary rates of secondary infections rates of secondary infections during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Secondary quinolone side effects quinolone side effects during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)