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)

NCT03176134 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 1986-018MK-1986-0182016-003884-20
• Study Type: interventional
• Target: 100
• Locations: 14 countries
• Sites: 58

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).

Conditions

Acute Bacterial Skin and Skin Structure Infections

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experienced an Adverse Event (AE)

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported.

  Up to approximately 35 days

• Number of Participants Who Discontinued Study Treatment Due to an AE

  An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Number of participants who experienced an AE were reported. The number of participants who discontinued study treatment due to an AE were reported.

  Up to approximately day 15

• Number of Participants With Hematopoietic Cytopenias

  Hematopoietic cytopenia is a condition where there is a lower-than-normal amount of one or multiple kinds of blood cells. A standardized Medical Dictionary for Regulatory Activities (MedDRA) query for hematopoietic cytopenia was conducted. The number of participants with a hematopoietic cytopenia were reported.

  Up to approximately 35 days

Secondary Outcomes (2)

• Percentage of Participants With Clinical Response (CR) Per Investigator Assessment

  Up to approximately 25 days

• Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment

  Up to approximately 25 days

Study Arms (8)

Cohort 1: Tedizolid phosphate 6 to <12 Years

EXPERIMENTAL

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.

Drug: Tedizolid phosphate

Cohort 1: Comparator 6 to <12 Years

ACTIVE COMPARATOR

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

Drug: Comparator

Cohort 2: Tedizolid phosphate 2 to <6 Years

EXPERIMENTAL

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.

Drug: Tedizolid phosphate

Cohort 2: Comparator 2 to <6 Years

ACTIVE COMPARATOR

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

Drug: Comparator

Cohort 3: Tedizolid phosphate 28 Days to <2 Years

EXPERIMENTAL

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.

Drug: Tedizolid phosphate

Cohort 3: Comparator 28 Days to <2 Years

ACTIVE COMPARATOR

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

Drug: Comparator

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

EXPERIMENTAL

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.

Drug: Tedizolid phosphate

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

ACTIVE COMPARATOR

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

Drug: Comparator

Interventions

Tedizolid phosphate DRUG

Tedizolid phosphate IV solution or oral suspension

Also known as: MK-1986, TR-701 FA

Cohort 1: Tedizolid phosphate 6 to <12 Years; Cohort 2: Tedizolid phosphate 2 to <6 Years; Cohort 3: Tedizolid phosphate 28 Days to <2 Years; Cohort 4: Tedizolid phosphate Birth to <28 Days Term and Preterm Neonates

Comparator 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 1: Comparator 6 to <12 Years; Cohort 2: Comparator 2 to <6 Years; Cohort 3: Comparator 28 Days to <2 Years; Cohort 4: Comparator Birth to <28 Days Term and Preterm Neonates

Eligibility Criteria

• Age: 1 Day - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (58)

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

San Diego, California, 92123, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Children's Hospital of Michigan ( Site 0100)

Detroit, Michigan, 48201, United States

Location

William Beaumont Hospital ( Site 0108)

Royal Oak, Michigan, 48073, United States

Location

St. Louis Children's Hospital ( Site 0127)

St Louis, Missouri, 63110, United States

Location

Cook Children's Medical Center ( Site 0124)

Fort Worth, Texas, 76104, United States

Location

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

Houston, Texas, 77030, United States

Location

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

Richmond, Virginia, 23219, United States

Location

Hospital Pequeno Principe ( Site 0276)

Curitiba, Paraná, 80250-060, Brazil

Location

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

Recife, Pernambuco, 50070-902, Brazil

Location

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

Natal, Rio Grande do Norte, 59025-050, Brazil

Location

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

São Paulo, 04321-120, Brazil

Location

MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)

Lom, Montana, 3600, Bulgaria

Location

UMHAT Deva Maria ( Site 0333)

Burgas, 8127, Bulgaria

Location

MHAT City Clinic Sv. Georgi EOOD ( Site 0334)

Montana, 3400, Bulgaria

Location

MHAT Dr. Stamen Iliev AD ( Site 0339)

Montana, 3400, Bulgaria

Location

UMHAT Dr. Georgi Stranski EAD ( Site 0330)

Pleven, 5800, Bulgaria

Location

UMHAT Sv. Georgi ( Site 0332)

Plovdiv, 4002, Bulgaria

Location

MBAL Medica Ruse EOOD ( Site 0336)

Rousse, 7000, Bulgaria

Location

UMHAT Kanev AD ( Site 0337)

Rousse, 7002, Bulgaria

Location

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

Sofia, 1606, Bulgaria

Location

JSC Evex Hospitals. ( Site 0601)

Batumi, Adjara, 6010, Georgia

Location

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

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

Location

JSC Evex Hospital ( Site 0602)

Tbilisi, 0159, Georgia

Location

JSC Evex Hospitals ( Site 0603)

Tbilisi, 0159, Georgia

Location

Haunersches Kinderspital ( Site 0480)

München, Bavaria, 80337, Germany

Location

Clinica Privada ( Site 0551)

Guatemala City, 01001, Guatemala

Location

Private Practice Mario Melgar ( Site 0552)

Guatemala City, 01009, Guatemala

Location

Private Practice Dra. Manrique ( Site 0553)

Guatemala City, 01010, Guatemala

Location

Daugavpils Regional Hospital ( Site 0651)

Daugavpils, 5417, Latvia

Location

Liepaja Regional Hospital ( Site 0652)

Liepāja, 3414, Latvia

Location

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

Kaunas, 50161, Lithuania

Location

Klaipedos Vaiku Ligonine ( Site 0700)

Klaipėda, 92140, Lithuania

Location

Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)

Vilnius, 08406, Lithuania

Location

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

Guadalajara, Jalisco, 44280, Mexico

Location

Instituto Nacional de Pediatria ( Site 0231)

Mexico City, Mexico City, 04530, Mexico

Location

Hospital Infantil de Mexico Federico Gomez ( Site 0227)

Mexico City, Mexico City, 06720, Mexico

Location

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

General Escobedo, Nuevo León, 64060, Mexico

Location

Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)

Aguascalientes, 20259, Mexico

Location

Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030, Poland

Location

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

Łomianki, Masovian Voivodeship, 05-092, Poland

Location

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

Lodz, Łódź Voivodeship, 91-347, Poland

Location

City Childrens Clinical Emergency Hospital ( Site 0507)

Novosibirsk, Novosibirsk Oblast, 630007, Russia

Location

Smolensk Regional Clinical Hospital ( Site 0511)

Smolensk, Smolensk Oblast, 214018, Russia

Location

Children s Republican Clinical Hospital ( Site 0512)

Kazan', Tatarstan, Respublika, 420138, Russia

Location

Emmed Research Incorporating ( Site 0377)

Pretoria, Gauteng, 0084, South Africa

Location

Setshaba Research Centre ( Site 0378)

Pretoria, Gauteng, 0152, South Africa

Location

Enhancing Care Foundation-DICRS ( Site 0381)

Durban, KwaZulu-Natal, 4013, South Africa

Location

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

Adana, 01330, Turkey (Türkiye)

Location

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)

Ankara, 06230, Turkey (Türkiye)

Location

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

Ankara, 06800, Turkey (Türkiye)

Location

Osmangazi UTF ( Site 0357)

Eskişehir, 26480, Turkey (Türkiye)

Location

Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)

Istanbul, 34093, Turkey (Türkiye)

Location

Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)

Istanbul, 34371, Turkey (Türkiye)

Location

Ege UTF ( Site 0356)

Izmir, 35040, Turkey (Türkiye)

Location

Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)

Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

Location

SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)

Dnipro, Dnipropetrovsk Oblast, 49100, Ukraine

Location

Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 40233296 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Interventions

tedizolid phosphate

Results Point of Contact

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

ClinicalTrialsDisclosure@msd.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
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: January 20, 2019
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: July 31, 2025
• Results First Posted: July 3, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ME (5); GU (3); RU (3); DE (1); BU (9); PL (3); ZA (3); US (8); GE (4); BR (4); TU (7); UA (3); LI (3); LA (2)