Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-03-14 @ 4:04 AM
Study NCT ID:
NCT01994993
Status:
COMPLETED
Last Update Posted:
2019-05-30
First Post:
2013-11-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibiotic Safety (SCAMP)
Sponsor:
Michael Cohen-Wolkowiez
Organization:
Study Overview
Official Title:
Antibiotic Safety in Infants With Complicated Intra-Abdominal Infections (SCAMP Trial)
Status:
COMPLETED
Status Verified Date:
2019-05
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:
SCAMP
Brief Summary:
The main purpose of this study is evaluate whether it is safe or not to use various combination of antibiotics (ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, gentamicin) in treating infants with complicated intra-abdominal infections
Detailed Description:
The most commonly used antibiotics in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. This study will provide the safety information required for labeling. In addition, the pharmacokinetics(PK) and effectiveness data will also be collected during this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HHSN275201000003I | OTHER_GRANT | NICHD | View |