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Tedizolid phosphate for Skin Infections

Phase 3
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 up to day 35
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of tedizolid phosphate to another antibiotic in children with ABSSSI.

Eligible Conditions
  • Skin Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 35
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants discontinuing from study therapy due to AEs
Percentage of participants with hematopoietic cytopenias
Percentage of participants with ≥1 adverse events (AEs)
Secondary outcome measures
Percentage of participants with clinical success

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 4: Tedizolid phosphate Birth to <28 Days NeonatesExperimental Treatment1 Intervention
Participants will receive tedizolid phosphate ≤200 mg daily dose, IV and/or oral suspension for 6 to 10 days. Exact mg/kg dose is to be determined based on results of another study covering the age range.
Group II: Cohort 3: Tedizolid phosphate 28 Days to <2 YearsExperimental Treatment1 Intervention
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Group III: Cohort 2: Tedizolid phosphate 2 to <6 YearsExperimental Treatment1 Intervention
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Group IV: Cohort 1: Tedizolid phosphate 6 to <12 YearsExperimental Treatment1 Intervention
Participants will receive tedizolid phosphate once-daily single 200-mg dose (body weight ≥50 kg) or twice-daily 2-mg/kg doses (body weight 30 kg to <50 kg); or twice-daily 2.5-mg/kg doses (body weight 3.2 kg to <30 kg), by IV and/or oral suspension for 6 to 10 days.
Group V: Cohort 3: Comparator: 28 Days to <2 YearsActive Control1 Intervention
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Group VI: Comparator: Birth to <28 Days (Term and preterm neonates)Active Control1 Intervention
Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days
Group VII: Cohort 1 Comparator: 6 to <12 YearsActive Control1 Intervention
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Group VIII: Cohort 2 Comparator: 2 to <6 YearsActive Control1 Intervention
Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tedizolid phosphate
2014
Completed Phase 4
~850

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,722 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,884 Previous Clinical Trials
5,054,286 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,776 Previous Clinical Trials
8,063,347 Total Patients Enrolled

Frequently Asked Questions

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

What are some other instances in which Tedizolid phosphate has been studied?

"At the moment, there are 2 ongoing clinical trials researching Tedizolid phosphate. 1 of these active studies is in its third phase. Most of the trials for Tedizolid phosphate take place in Sao Paulo or Tbilisi, but 87 research sites around the world are conducting these tests."

Answered by AI

Are patients currently being signed up for this clinical trial?

"Yes, this trial is currently looking for participants. The listing on clinicaltrials.gov says that the study was first posted on 1/20/2019 and last updated on 11/10/2022."

Answered by AI

To your knowledge, does a similar study exist?

"Tedizolid phosphate has been under research study since 2019 when an initial trial was conducted by Merck Sharp & Dohme Corp. In order to Phase 3 drug approval, a second 100-person study was completed with successful results. As of now, there are 2 active trials for Tedizolid phosphate in 17 countries and 45 cities."

Answered by AI

Are there any reported Tedizolid phosphate-related fatalities?

"There is some evidence to support the efficacy of Tedizolid phosphate, as this medication is in Phase 3 clinical trials. Additionally, there is extensive safety data available for this drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
2019. "A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03176134.
~16 spots leftby Apr 2025
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