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Oxazolidinone Antibiotic

IV Tedizolid Phosphate for Gram-Positive Infections

Phase 1
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up iv treatment: after the end of infusion, 1.5, 3, 6, 12, 24 hours after the start of infusion; oral suspension treatment: 1, 3, 5, 8, 12, and 24 hours postdose
Awards & highlights

Study Summary

This trial is testing the effects of tedizolid phosphate on different age groups of children.

Eligible Conditions
  • Gram-Positive Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~iv treatment: after the end of infusion, 1.5, 3, 6, 12, 24 hours after the start of infusion; oral suspension treatment: 1, 3, 5, 8, 12, and 24 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and iv treatment: after the end of infusion, 1.5, 3, 6, 12, 24 hours after the start of infusion; oral suspension treatment: 1, 3, 5, 8, 12, and 24 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC0-inf of tedizolid
AUC0-inf of tedizolid phosphate
AUC0-last of tedizolid
+7 more
Secondary outcome measures
Adverse Events (AEs)
Discontinuations

Trial Design

2Treatment groups
Experimental Treatment
Group I: Oral Suspension Tedizolid PhosphateExperimental Treatment1 Intervention
A single dose of tedizolid phosphate administered as an oral suspension. For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
Group II: IV Tedizolid PhosphateExperimental Treatment1 Intervention
A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered intravenously (IV). For body weight <10 kg: 3 mg/kg; for body weight 10 to <30 kg: 2.5 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral Suspension Tedizolid Phosphate
2019
Completed Phase 1
~50
IV Tedizolid Phosphate
2019
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,965 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,911 Previous Clinical Trials
5,066,617 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,796 Previous Clinical Trials
8,069,052 Total Patients Enrolled
~7 spots leftby Jun 2025
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