Status:
RECRUITING
CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Acute Lymphoblastic Leukaemia - Category
Eligibility:
All Genders
1-17 years
Phase:
NA
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. To assess the efficacy of ciprofloxacin prop...
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 pati...
Eligibility Criteria
Inclusion
- 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
- Non-participants of the ALLTogether-1 trial
- Patients with Down syndrome who already receive ciprofloxacin prophylaxis
- Chronic active arthritis
- Other contraindication to fluoroquinolones
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
1052 Patients enrolled
Trial Details
Trial ID
NCT04678869
Start Date
June 29 2022
End Date
December 31 2031
Last Update
March 8 2024
Active Locations (14)
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1
Royal Aberdeen Children's Hospital
Aberdeen, United Kingdom
2
Bristol Royal Hospital for Children
Bristol, United Kingdom
3
Addenbrookes Hospital
Cambridge, United Kingdom
4
Leeds General Infirmary
Leeds, United Kingdom