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NCT03176134 Clinical Trial

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)

Acute Bacterial Skin and Skin Structure Infections Clinical Trial

Official title:
A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03176134
Other study ID # 1986-018
Secondary ID MK-1986-0182016-
Status Completed
Phase Phase 3
First received
Last updated
Start date January 20, 2019
Est. completion date July 6, 2023

Study information
Verified date July 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and skin structure infections (ABSSSI).

Description:

Participants will be randomized (3:1) to receive tedizolid phosphate at a weight-based dose ≤200 mg/day, intravenous (IV) and/or oral suspension for 6 to 10 days, or comparator IV and/or oral per local standard of care for 10 to 14 days. The switch from IV to oral administration can be made at any time based on 1) no worsening of the primary skin lesion, 2) last temperature <37.7 °C, and 3) primary acute bacterial skin and skin structure infection (ABSSSI) site has not worsened and at least 1 site has improved from Baseline. The potential 4-day treatment extension will be based on clinical need as judged by the investigator, considering the following criteria: 1) ≥40% reduction in primary lesion size, 2) reduction in pain, and 3) no new signs and symptoms and no complications attributable to ABSSSI compared with Baseline.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tedizolid phosphate
Tedizolid phosphate IV solution or oral suspension
• Comparator
Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care
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Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Brazil,  Bulgaria,  Georgia,  Germany,  Guatemala,  Latvia,  Lithuania,  Mexico,  Poland,  Russian Federation,  South Africa,  Turkey,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants with =1 adverse events (AEs) An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an adverse event. The percentage of participants with one or more AEs will be reported. Up to Day 35
Primary Percentage of participants discontinuing from study therapy due to AEs An AE is any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants discontinued from the study due to an AE will be reported. Up to Day 35
Primary Percentage of participants with hematopoietic cytopenias A standardized MedDRA query for hematopoietic cytopenia will be conducted. The percentage of participants with a hematopoietic cytopenia will be reported. Up to Day 35
Secondary Percentage of participants with clinical success The investigator's assessment of clinical response will be conducted at the Test of Cure (TOC) visit, approximately 25 days after the first infusion. Clinical success is defined as 1) resolution or near-resolution of most signs and symptoms, 2) absence or near-resolution of signs of infection, and 3) no new signs, symptoms, or complications attributable to the infections (no further antibiotic therapy required for the primary lesion). The percentage of participants with clinical success will be reported. Day 25
See also
  Status Clinical Trial Phase
Terminated NCT01734694 - Safety and Efficacy of Strategy to Prevent Drug-Induced Nephrotoxicity in High-Risk Patients Phase 4
Completed NCT02961764 - Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 4
Completed NCT02570490 - Oral Sodium Fusidate (CEM-102) Versus Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT00949130 - Comparative Study of NXL103 Versus Linezolid in Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 2
Completed NCT03137173 - Ceftobiprole in the Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections Phase 3
Completed NCT03405064 - Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Phase 3

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