Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05826990
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-01-30
Brief Title:
A Study to Investigate PK Safety Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI
Sponsor:
Allecra
Organization:
Allecra
Study Overview
Official Title:
Single Group Phase 2 Study to Investigate Pharmacokinetics Safety and Tolerability of Cefepime-Enmetazobactam Administered by IV Over 2 Hr in Male or Female Participants From Birth to Less Than 18 Years of Age Hospitalised With cUTI
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
This phase 2 study is part of regulatory commitments in the United States PSP and Europe PIP to evaluate cefepime-enmetazobactam in paediatric participants with cUTI to support extension of the indication for cefepime-enmetazobactam to children with cUTI
Detailed Description:
The purpose of this study is to evaluate the blood concentrations and safety of the fixed dose combination of 2 drugs cefepime with enmetazobactam administered intravenously in participants aged from birth to less than 18-years of age hospitalised with a complicated urinary tract infection
The treatment duration will be between 3 and 7 days depending on the time needed for disappearance of signs and symptoms of the infection
The participant will need to be hospitalised at least during the treatment administration period After the last administration of cefepime and enmetazobactam there will be the end of treatment visit EOT then 2 follow-up visits at 7 days Test of Cure TOC then 14 days Late Follow-up LFU after the end of treatment visit The End of study Visit EOS will be conducted via telephone call or a visit deemed necessary as per the investigator 28 days after the EOT visit The participants may be discharged from hospital at the discretion of the investigator after the end of treatment visit but will be required to return to the hospital for the 2 follow-up visits
The treatment duration will be between 3 and 7 days depending on the time needed for disappearance of signs and symptoms of the infection
The participant will need to be hospitalised at least during the treatment administration period After the last administration of cefepime and enmetazobactam there will be the end of treatment visit EOT then 2 follow-up visits at 7 days Test of Cure TOC then 14 days Late Follow-up LFU after the end of treatment visit The End of study Visit EOS will be conducted via telephone call or a visit deemed necessary as per the investigator 28 days after the EOT visit The participants may be discharged from hospital at the discretion of the investigator after the end of treatment visit but will be required to return to the hospital for the 2 follow-up visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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