CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Omadacycline Injection [Nuzyra] +1 moredrug
Likely dose
Omadacycline Injection [Nuzyra] 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05217537
NCT05217537Phase 1Completed
CompareCT.gov

A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections

Paratek Pharmaceuticals Inc·interventional·Posted Feb 1, 2022·Updated Mar 9, 2026

In Brief

A Phase 1 clinical trial evaluating Omadacycline Injection [Nuzyra] and Omadacycline Oral Tablet for Bacterial Infections. Completed, enrolled 23 participants across 9 sites.

Detailed Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedFeb 1, 2022
Enrollment StartApr 6, 2022
Primary CompletionFeb 27, 2025
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 4.4 years ago

Interventions

Omadacycline Injection [Nuzyra]drug

Single dose of 100 mg omadacycline IV in 100 mL of normal saline

Omadacycline Oral Tabletdrug

Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)