Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)

NCT02276482 | Completed Phase 3 Results DMC FDA Drug

• 4 other identifiers: 1986-012TR701-1222014-004023-40MK-1986-012
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the safety of intravenous (IV) and/or oral 6-day 200 mg tedizolid phosphate with 10-day comparator in participants 12 to \<18 years with cSSTI.

Conditions

Skin Diseases, Infectious; Skin Diseases, Bacterial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events on Tedizolid Phosphate and Comparator Drugs

  An adverse event (AE) refers to a treatment-emergent adverse event (TE-AE). A TE-AE is any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug.

  Up to 40 days (including 30-day follow-up)

Secondary Outcomes (5)

• Number of Participants With Investigator's Assessment Indicating Clinical Success at Test of Cure (TOC) Visit (Intent to Treat Analysis Set)

  TOC Visit: 18-25 days after first drug infusion

• Number of Participants With Investigator's Assessment Indicating Clinical Success at TOC Visit (Clinically Evaluable-Test of Cure [CE-TOC] Analysis Set)

  TOC Visit: 18-25 days after first drug infusion

• Number of Participants With Early Clinical Responses Measured by Lesion Reduction

  48-72 hr after first drug infusion

• Number of Participants With Investigator's Assessment Indicating Clinical Success at End of Therapy (EOT) Visit (Intent to Treat Analysis Set)

  EOT Visit: up to 13 days after first drug infusion

• Number of Participants With Investigator's Assessment Indicating Clinical Success at EOT Visit (Clinically Evaluable-End of Therapy [CE-EOT] Analysis Set)

  EOT Visit: up to 13 days after first drug infusion

Other Outcomes (3)

• Change From Baseline in Lesion Size

  Baseline and TOC visit (18 to 25 days after infusion)

• Peak Plasma Concentration (Cmax) of Tedizolid

  Day 1 at 5-80 minutes (min) and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9

• Area Under the Plasma Concentration Versus Time Curve Time 0 to 24 Hours (AUC0-24h) of Tedizolid

  Day 1 at 5-80 min and 4-12 hrs post-infusion or 2 samples collected between 4-12 hrs after oral dose, at least 60 min apart; at 48-72 hrs: within 60 min prior to administration and 4-12 hrs after administration; and anytime between Day 7 and 9

Study Arms (2)

Tedizolid Phosphate

EXPERIMENTAL

Tedizolid Phosphate IV and/or oral 200 mg once per day for 6 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

Drug: Tedizolid Phophate; Drug: Aztreonam; Drug: Metronidazole

Antibiotic comparator drug

ACTIVE COMPARATOR

IV and/or oral antibiotic comparator drug for 10 days. Participants with gram-negative wound infection may receive aztreonam (IV) and/or metronidazole (IV or oral).

Drug: Antibiotic comparator; Drug: Aztreonam; Drug: Metronidazole

Interventions

Tedizolid Phophate DRUG

Tedizolid Phophate 200 mg, IV and/or oral for 6 days

Also known as: TR701-122, MK-1986, SIVEXTRO®

Tedizolid Phosphate

Antibiotic comparator DRUG

Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.

Also known as: Vancomycin: Vancocin, Firvanq, Lyphocin; Linezolid: Zyvox; Clindamycin: Cleocin; Flucloxacillin: Floxapen, Flopen, Staphylex; Cefazolin: Ancef, Kefzol; Cephalexin: Keflex, Zartan, Panixine, Biocef

Antibiotic comparator drug

Aztreonam DRUG

In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.

Also known as: Azactam, Cayston

Antibiotic comparator drug; Tedizolid Phosphate

Metronidazole DRUG

Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.

Also known as: Flagyl, Metro

Antibiotic comparator drug; Tedizolid Phosphate

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females 12 years to \<18 years
• Adequate venous access for IV administration of study drug for at least 24 hours (for participants receiving IV medication) and collection of protocol-specified blood samples
• Local symptoms must have started within 7 days before Study Day -1
• cSSTI meeting at least 1 of the clinical syndrome definitions.
• Suspected or documented Gram-positive infection from baseline Gram stain or culture.
• Parent/legally authorized representative (LAR) able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children who in the Investigator's judgment are capable of understanding the nature of the study

You may not qualify if:

• Uncomplicated minor skin and skin structure infections such as pustules, folliculitis, furuncles, minor abscesses (small volume of suppuration not surrounded by cellulitis/erysipelas), impetiginous lesions, superficial or limited cellulitis/erysipelas, and minor wound associated foreign body reactions (eg, stitch abscesses)
• Known bacteremia, severe sepsis or septic shock
• Recent history of opportunistic infections where the underlying cause of these infections is still active (eg, leukemia, transplant, acquired immunodeficiency syndrome)
• Hypersensitivity to tedizolid phosphate or any component in the formulation
• Hypersensitivity to all of the comparator drugs; hypersensitivity to a comparator drug does not preclude participation if an alternative comparator can be used
• For participants with wound infections: history of hypersensitivity to ceftazidime, aztreonam, or any component of the aztreonam formulation, if aztreonam adjunctive therapy is required; history of hypersensitivity to metronidazole or any component of the formulation, if metronidazole adjunctive therapy is required
• Needs oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug.
• Uses monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors and serotonin 5 hydroxytryptamine receptor agonists (triptans) within 14 days prior to study drug administration

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead

Related Publications (1)

• Bradley JS, Antadze T, Ninov B, Tayob MS, Broyde N, Butterton JR, Chou MZ, De Anda CS, Kim JY, Sears PS. Safety and Efficacy of Oral and/or Intravenous Tedizolid Phosphate From a Randomized Phase 3 Trial in Adolescents With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2021 Mar 1;40(3):238-244. doi: 10.1097/INF.0000000000003010.

  PMID: 33395210 DERIVED

MeSH Terms

Conditions

Skin Diseases, Infectious; Skin Diseases, Bacterial

Interventions

tedizolid phosphate; Vancomycin; Cefazolin; Cephalexin; Aztreonam; Metronidazole

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Monobactams; Heterocyclic Compounds, 1-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme, Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: October 28, 2014
• Study Start: March 25, 2015
• Primary Completion: September 17, 2018
• Study Completion: September 17, 2018
• Last Updated: August 7, 2019
• Results First Posted: August 7, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share