CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
NCT ID: NCT04678869
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1052 participants
INTERVENTIONAL
2022-06-29
2031-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cirprofloxacin prophylaxis
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Ciprofloxacin
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Standard of care
standard of care
Antibiotic
Standard of care antibiotic as per local policy
Interventions
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Ciprofloxacin
prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
Antibiotic
Standard of care antibiotic as per local policy
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Patients with Down syndrome who already receive ciprofloxacin prophylaxis
* Chronic active arthritis
* Other contraindication to fluoroquinolones
1 Year
17 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University College, London
OTHER
Responsible Party
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Principal Investigators
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Robert Phillips
Role: PRINCIPAL_INVESTIGATOR
University of York
Locations
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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, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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CiproPAL (129038)
Identifier Type: -
Identifier Source: org_study_id
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