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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
4,582,236 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,888 Previous Clinical Trials
5,054,957 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,817 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals aged 75 or older being admitted into this experiment?

"As per the criteria of this medical trial, eligible participants must be within 1 Day and 24 Months old."

Answered by AI

Is there a possibility of me joining this clinical experiment?

"This study is in search of 42 infants and toddlers between the age of 24 hours to two years old. The prerequisites for participation are as follows: Being at least 1 kg, having an adequately functioning circulatory system, being actively treated with antibiotics that target gram-positive bacteria, and exhibiting no noteworthy electrocardiogram abnormalities."

Answered by AI

To what extent is patient enrollment in this trial limited?

"Affirmative. Data available on clinicaltrials.gov confirms that this research endeavour, which was initially published on February 6th 2019, is actively enrolling participants. At present, 42 individuals must be recruited from 2 distinct medical centres."

Answered by AI

Has the FDA sanctioned Tedizolid Phosphate for intravenous use?

"Given the limited clinical data suggesting its efficacy and safety, IV Tedizolid Phosphate received a score of 1."

Answered by AI

Could you provide some examples of previous experiments with IV Tedizolid Phosphate?

"Tedizolid Phosphate in a IV form was initially studied at Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353) back in 2019. Since then, 22 trials have been completed and 2 are still ongoing with the majority taking place near Saint Louis, Missouri."

Answered by AI

Has this research been conducted previously?

"Research into IV Tedizolid Phosphate has been ongoing since 2019, when Merck Sharp & Dohme Corp. sponsored its initial trial of 100 participants. Following this Phase 1 study, the drug was approved and entered Phase 3 trials across 17 countries in 45 cities. Currently there are still two active studies underway involving IV Tedizolid Phosphate."

Answered by AI

Can individuals who meet the criteria participate in this trial at present?

"Confirmed, the clinical trial is accepting enrollees. This experimental study was first posted on February 6th 2019 and has recently been updated as of November 29th 2022 according to information hosted by clinicaltrials.gov."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)
2019. "A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03217565.
~8 spots leftby Apr 2025
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