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)

NCT ID: NCT03176134

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2023-07-06

Brief 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).

Detailed 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.

Conditions

Acute Bacterial Skin and Skin Structure Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cohort 1: Tedizolid phosphate 6 to <12 Years

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 Type: EXPERIMENTAL

Tedizolid phosphate

Intervention Type: DRUG

Tedizolid phosphate IV solution or oral suspension

Cohort 1: Comparator 6 to <12 Years

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: DRUG

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

Cohort 2: Tedizolid phosphate 2 to <6 Years

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 Type: EXPERIMENTAL

Tedizolid phosphate

Intervention Type: DRUG

Tedizolid phosphate IV solution or oral suspension

Cohort 2: Comparator 2 to <6 Years

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: DRUG

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

Cohort 3: Tedizolid phosphate 28 Days to <2 Years

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 Type: EXPERIMENTAL

Tedizolid phosphate

Intervention Type: DRUG

Tedizolid phosphate IV solution or oral suspension

Cohort 3: Comparator 28 Days to <2 Years

Participants will receive comparator IV and/or oral per local standard of care for 10 to 14 days.

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: DRUG

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

Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates

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 (NCT03217565) covering the age range.

Group Type: EXPERIMENTAL

Tedizolid phosphate

Intervention Type: DRUG

Tedizolid phosphate IV solution or oral suspension

Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates

Participants will receive comparator IV and/or oral per local standard of care for 10 to14 days.

Group Type: ACTIVE_COMPARATOR

Comparator

Intervention Type: DRUG

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

Interventions

Tedizolid phosphate

Tedizolid phosphate IV solution or oral suspension

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

MK-1986; TR-701 FA

Eligibility Criteria

Inclusion Criteria

• Has a parent/legally acceptable representative who is able to give documented informed consent
• Has acute bacterial skin and skin structure infections (ABSSSI), defined as ≥1 of the following: 1) cellulitis/erysipelas, 2) major cutaneous abscess, or 3) wound infection
• Local symptoms of ABSSSI that started within 14 days before study start
• Suspected or documented Gram-positive bacterial infection

Exclusion Criteria

• Uncomplicated skin and skin structure infection
• ABSSSI due to or associated with disallowed etiology per protocol
• Received antibacterial therapy for treatment of the current episode of ABSSSI except 1) <48 hours of antibacterial therapy with a short-acting antibacterial drug, or 2) response is considered to be failure (no improvement in signs and symptoms) after at least 48 hours of therapy
• Known bacteremia, severe sepsis, or septic shock
• Significant or life-threatening condition, disease, or organ system condition
• Recent history of opportunistic infections where the underlying cause of the infection is still active, or is suspected to be at risk of opportunistic infection with unusual pathogens
• Received or is receiving treatment for active tuberculosis within 1 month of study start
• Known or suspected severe neutropenia
• Human immunodeficiency virus (HIV) positive and has Cluster of Differentiation (CD) 4 cell count <15% (HIV testing is not required for eligibility)
• Renal impairment that requires renal filtration
• Severe hepatic impairment
• Cardiac or electrocardiogram (ECG) finding that would limit participation in the study
• Received an investigational medicinal product (not approved) within 30 days before study start
• Investigational device present or removed within 30 days before study start
• Previously treated with tedizolid phosphate
• Contraindication, including hypersensitivity to tedizolid phosphate, other oxazolidinones, or any component in the formulation
• Contraindication, including hypersensitivity to all available comparator drugs
• Wound infection and history of hypersensitivity to aztreonam adjunctive therapy or metronidazole adjunctive therapy, if adjunctive therapy is required
• Needs oral administration of methotrexate, topotecan, irinotecan, or rosuvastatin, during administration of oral study drug (administration during the follow-up period, ie, after the end of treatment (EOT) visit, is allowed, as is administration during treatment with IV drug)
• Female who is pregnant or nursing or is of childbearing potential and not abstinent; or male who is not abstinent
• Use of monoamine oxidase inhibitors, tricyclic antidepressants, buspirone, selective serotonin reuptake inhibitors, or serotonin 5-hydroxytryptamine receptor agonists (triptans)
• Identified as having used illicit drugs (urine drug screening not required for entry)

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Rady Children's Hospital-San Diego ( Site 0118)

San Diego, California, United States

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)

Chicago, Illinois, United States

Children's Hospital of Michigan ( Site 0100)

Detroit, Michigan, United States

William Beaumont Hospital ( Site 0108)

Royal Oak, Michigan, United States

St. Louis Children's Hospital ( Site 0127)

St Louis, Missouri, United States

Cook Children's Medical Center ( Site 0124)

Fort Worth, Texas, United States

Baylor College of Medicine - Texas Children's Hospital ( Site 0107)

Houston, Texas, United States

Children's Hospital of Richmond at VCU ( Site 0123)

Richmond, Virginia, United States

Hospital Pequeno Principe ( Site 0276)

Curitiba, Paraná, Brazil

Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)

Recife, Pernambuco, Brazil

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES

Natal, Rio Grande do Norte, Brazil

Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283)

São Paulo, , Brazil

MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)

Lom, Montana, Bulgaria

UMHAT Deva Maria ( Site 0333)

Burgas, , Bulgaria

MHAT City Clinic Sv. Georgi EOOD ( Site 0334)

Montana, , Bulgaria

MHAT Dr. Stamen Iliev AD ( Site 0339)

Montana, , Bulgaria

UMHAT Dr. Georgi Stranski EAD ( Site 0330)

Pleven, , Bulgaria

UMHAT Sv. Georgi ( Site 0332)

Plovdiv, , Bulgaria

MBAL Medica Ruse EOOD ( Site 0336)

Rousse, , Bulgaria

UMHAT Kanev AD ( Site 0337)

Rousse, , Bulgaria

UMHATEM. N.I.Pirogov. EAD ( Site 0331)

Sofia, , Bulgaria

JSC Evex Hospitals. ( Site 0601)

Batumi, Adjara, Georgia

Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600)

Tbilisi, K'alak'i T'bilisi, Georgia

JSC Evex Hospital ( Site 0602)

Tbilisi, , Georgia

JSC Evex Hospitals ( Site 0603)

Tbilisi, , Georgia

Haunersches Kinderspital ( Site 0480)

München, Bavaria, Germany

Clinica Privada ( Site 0551)

Guatemala City, , Guatemala

Private Practice Mario Melgar ( Site 0552)

Guatemala City, , Guatemala

Private Practice Dra. Manrique ( Site 0553)

Guatemala City, , Guatemala

Daugavpils Regional Hospital ( Site 0651)

Daugavpils, , Latvia

Liepaja Regional Hospital ( Site 0652)

Liepāja, , Latvia

Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701)

Kaunas, , Lithuania

Klaipedos Vaiku Ligonine ( Site 0700)

Klaipėda, , Lithuania

Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)

Vilnius, , Lithuania

Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230)

Guadalajara, Jalisco, Mexico

Instituto Nacional de Pediatria ( Site 0231)

Mexico City, Mexico City, Mexico

Hospital Infantil de Mexico Federico Gomez ( Site 0227)

Mexico City, Mexico City, Mexico

CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241)

General Escobedo, Nuevo León, Mexico

Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)

Aguascalientes, , Mexico

Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431)

Łomianki, Masovian Voivodeship, Poland

Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427)

Lodz, Łódź Voivodeship, Poland

City Childrens Clinical Emergency Hospital ( Site 0507)

Novosibirsk, Novosibirsk Oblast, Russia

Smolensk Regional Clinical Hospital ( Site 0511)

Smolensk, Smolensk Oblast, Russia

Children s Republican Clinical Hospital ( Site 0512)

Kazan', Tatarstan, Respublika, Russia

Emmed Research Incorporating ( Site 0377)

Pretoria, Gauteng, South Africa

Setshaba Research Centre ( Site 0378)

Pretoria, Gauteng, South Africa

Enhancing Care Foundation-DICRS ( Site 0381)

Durban, KwaZulu-Natal, South Africa

Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353)

Adana, , Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)

Ankara, , Turkey (Türkiye)

Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359)

Ankara, , Turkey (Türkiye)

Osmangazi UTF ( Site 0357)

Eskişehir, , Turkey (Türkiye)

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)

Istanbul, , Turkey (Türkiye)

Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)

Istanbul, , Turkey (Türkiye)

Ege UTF ( Site 0356)

Izmir, , Turkey (Türkiye)

Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)

Dnipro, Dnipropetrovsk Oblast, Ukraine

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)

Dnipro, Dnipropetrovsk Oblast, Ukraine

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Countries

United States; Brazil; Bulgaria; Georgia; Germany; Guatemala; Latvia; Lithuania; Mexico; Poland; Russia; South Africa; Turkey (Türkiye); Ukraine

References

Mngqibisa R, Fofanov O, Grazioso CF, Melgar Toledo M, Boddicker M, Broyde N, Koseoglu S, Romero L, Stevens M, Sears P. A Phase 3 Study of the Safety and Efficacy of Tedizolid Phosphate in Patients <12 Years of Age With Acute Bacterial Skin and Skin Structure Infections. Pediatr Infect Dis J. 2025 Jun 1;44(6):533-538. doi: 10.1097/INF.0000000000004807. Epub 2025 Apr 14.

Reference Type: RESULT

PMID: 40233296 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

https://msd.trialsummaries.com/Study/StudyDetails?id=26090&tenant=MT_MSD_9011

Plain Language Summary

Other Identifiers

MK-1986-018

Identifier Type: OTHER

Identifier Source: secondary_id

2016-003884-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1986-018

Identifier Type: -

Identifier Source: org_study_id