Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678869
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2020-12-05
Brief Title:
CiproPAL Ciprofloxacin Prophylaxis in Acute Leukaemia
Sponsor:
University College London
Organization:
University College London
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CiproPAL
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 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
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
Detailed Description:
This is a multi-centre randomised trial of prophylactic ciprofloxacin 10mgkg BD enteralIV 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 ie a reduction from 15 to 9 1052 patients randomised 11 gives 85 power with a 5 2-sided alpha
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 ie a reduction from 15 to 9 1052 patients randomised 11 gives 85 power with a 5 2-sided alpha
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None