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

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516385-10-00

Acronym

ML-ORI-201

Enrollment

292

Registered

2024-11-26

Start date

2023-05-02

Completion date

2025-11-07

Last updated

2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bacterial Skin and Skin Structure Infections

Brief summary

Safety assessment of ORBACTIV and KIMYRSA in pediatric populations

Detailed description

All-cause mortality assessed at the Time of Cure (ToC) visit

Interventions

DRUGAZACTAM 1 g

DRUGpoudre et solution pour usage parentéral

DRUGOritavancin

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Safety assessment of ORBACTIV and KIMYRSA in pediatric populations	—

Secondary

Measure	Time frame
All-cause mortality assessed at the Time of Cure (ToC) visit	—

Countries

Bulgaria, Greece, Latvia, Lithuania, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026