Clinical trial NCT03176134: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Skin and Skin Structure Infections
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Number of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to approximately 35 days
measure: Number of Participants Who Discontinued Study Treatment Due to an AE
timeFrame: Up to approximately day 15
measure: Number of Participants With Hematopoietic Cytopenias
timeFrame: Up to approximately 35 days
Secondary outcomes:
measure: Percentage of Participants With Clinical Response (CR) Per Investigator Assessment
timeFrame: Up to approximately 25 days
measure: Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment
timeFrame: Up to approximately 25 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital-San Diego ( Site 0118)
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)
state: Illinois
city: Detroit
country: United States
facility: Children's Hospital of Michigan ( Site 0100)
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital ( Site 0108)
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital ( Site 0127)
state: Missouri
city: Fort Worth
country: United States
facility: Cook Children's Medical Center ( Site 0124)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital ( Site 0107)
state: Texas
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU ( Site 0123)
state: Virginia
city: Curitiba
country: Brazil
facility: Hospital Pequeno Principe ( Site 0276)
state: Parana
city: Recife
country: Brazil
facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)
state: Pernambuco
city: Natal
country: Brazil
facility: Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES
state: Rio Grande Do Norte
city: Sao Paulo
country: Brazil
facility: Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283)
city: Lom
country: Bulgaria
facility: MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)
state: Montana
city: Burgas
country: Bulgaria
facility: UMHAT Deva Maria ( Site 0333)
city: Montana
country: Bulgaria
facility: MHAT City Clinic Sv. Georgi EOOD ( Site 0334)
city: Montana
country: Bulgaria
facility: MHAT Dr. Stamen Iliev AD ( Site 0339)
city: Pleven
country: Bulgaria
facility: UMHAT Dr. Georgi Stranski EAD ( Site 0330)
city: Plovdiv
country: Bulgaria
facility: UMHAT Sv. Georgi ( Site 0332)
city: Ruse
country: Bulgaria
facility: MBAL Medica Ruse EOOD ( Site 0336)
city: Ruse
country: Bulgaria
facility: UMHAT Kanev AD ( Site 0337)
city: Sofia
country: Bulgaria
facility: UMHATEM. N.I.Pirogov. EAD ( Site 0331)
city: Batumi
country: Georgia
facility: JSC Evex Hospitals. ( Site 0601)
state: Ajaria
city: Tiblisi
country: Georgia
facility: Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600)
state: Tbilisi
city: Tbilisi
country: Georgia
facility: JSC Evex Hospital ( Site 0602)
city: Tbilisi
country: Georgia
facility: JSC Evex Hospitals ( Site 0603)
city: München
country: Germany
facility: Haunersches Kinderspital ( Site 0480)
state: Bayern
city: Guatemala
country: Guatemala
facility: Clinica Privada ( Site 0551)
city: Guatemala
country: Guatemala
facility: Private Practice Mario Melgar ( Site 0552)
city: Guatemala
country: Guatemala
facility: Private Practice Dra. Manrique ( Site 0553)
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital ( Site 0651)
city: Liepaja
country: Latvia
facility: Liepaja Regional Hospital ( Site 0652)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701)
city: Klaipeda
country: Lithuania
facility: Klaipedos Vaiku Ligonine ( Site 0700)
city: Vilnius
country: Lithuania
facility: Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Pediatria ( Site 0231)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Hospital Infantil de Mexico Federico Gomez ( Site 0227)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230)
state: Jalisco
city: Gral Escobedo
country: Mexico
facility: CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241)
state: Nuevo Leon
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427)
state: Lodzkie
city: Lomianki
country: Poland
facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431)
state: Mazowieckie
city: Novosibirsk
country: Russian Federation
facility: City Childrens Clinical Emergency Hospital ( Site 0507)
state: Novosibirskaya Oblast
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital ( Site 0511)
state: Smolenskaya Oblast
city: Kazan
country: Russian Federation
facility: Children s Republican Clinical Hospital ( Site 0512)
state: Tatarstan, Respublika
city: Pretoria
country: South Africa
facility: Emmed Research Incorporating ( Site 0377)
state: Gauteng
city: Pretoria
country: South Africa
facility: Setshaba Research Centre ( Site 0378)
state: Gauteng
city: Durban
country: South Africa
facility: Enhancing Care Foundation-DICRS ( Site 0381)
state: Kwazulu-Natal
city: Adana
country: Turkey
facility: Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)
city: Ankara
country: Turkey
facility: Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359)
city: Eskisehir
country: Turkey
facility: Osmangazi UTF ( Site 0357)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)
city: Istanbul
country: Turkey
facility: Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)
city: Izmir
country: Turkey
facility: Ege UTF ( Site 0356)
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)
state: Dnipropetrovska Oblast
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)
state: Ivano-Frankivska Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: