Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-30 @ 7:48 AM
Study NCT ID:
NCT05599295
Status:
COMPLETED
Last Update Posted:
2025-11-25
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety of Intravenous Oritavancin for the Treatment of Children With Skin Infections
Sponsor:
Melinta Therapeutics, LLC
Organization:
Study Overview
Official Title:
A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous Oritavancin for the Treatment of Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections
Status:
COMPLETED
Status Verified Date:
2025-11
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 protocol describes a randomized, open-label study to evaluate the safety and tolerability of 2 formulations of single-dose intravenous (IV) oritavancin diphosphate (Orbactiv and Kimyrsa) for the treatment of pediatric participants with acute bacterial skin and skin structure infections (ABSSSIs).
This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).
The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.
This study involves 2 oritavancin products, Orbactiv and Kimyrsa. Oritavancin is the active drug substance in both Orbactiv and Kimyrsa. This study protocol distinguishes the differences between Orbactiv and Kimyrsa by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data and information and guidance that is not specific to Orbactiv or Kimyrsa (that is, applies to both).
The study involves pharmacokinetic sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to participants and their caregivers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-516385-10-00 | CTIS | None | View |