Acute Bacterial Skin and Skin Structure InfectionsPhase 3NCT03176134
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)
A Phase 3 study testing Tedizolid phosphate and Comparator in people with Acute Bacterial Skin and Skin Structure Infections, run by Merck Sharp & Dohme LLC at 58 sites in 14 countries.
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). Read more about this study
- Who is it for?
- Ages 1 day to 11 years
- Conditions the study is for
- Acute Bacterial Skin and Skin Structure Infections
- What is being tested?
- Tedizolid phosphate and Comparator
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 58 sitesin 14 countries
- Study dates
- 20 Jan 2019to 6 Jul 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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)
Trial locations and contacts
58 sites in 14 countries.
58 sites in 14 countries
Bulgaria9 sites
UMHAT Deva Maria ( Site 0333)
Burgas, 8127
MHAT Sv. Nikolay Chudotvorets EOOD ( Site 0338)
Lom, Montana, 3600
MHAT City Clinic Sv. Georgi EOOD ( Site 0334)
Montana, 3400
MHAT Dr. Stamen Iliev AD ( Site 0339)
Montana, 3400
UMHAT Dr. Georgi Stranski EAD ( Site 0330)
Pleven, 5800
UMHAT Sv. Georgi ( Site 0332)
Plovdiv, 4002
MBAL Medica Ruse EOOD ( Site 0336)
Rousse, 7000
UMHAT Kanev AD ( Site 0337)
Rousse, 7002
UMHATEM. N.I.Pirogov. EAD ( Site 0331)
Sofia, 1606
United States8 sites
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 0129)
Chicago, Illinois, 60611
Children's Hospital of Michigan ( Site 0100)
Detroit, Michigan, 48201
Cook Children's Medical Center ( Site 0124)
Fort Worth, Texas, 76104
Baylor College of Medicine - Texas Children's Hospital ( Site 0107)
Houston, Texas, 77030
Children's Hospital of Richmond at VCU ( Site 0123)
Richmond, Virginia, 23219
William Beaumont Hospital ( Site 0108)
Royal Oak, Michigan, 48073
Rady Children's Hospital-San Diego ( Site 0118)
San Diego, California, 92123
St. Louis Children's Hospital ( Site 0127)
St Louis, Missouri, 63110
Turkey (Türkiye)7 sites
Cukurova Uni Tip Fak Cocuk Saglıgı ve Hasta ABD ( Site 0353)
Adana, 01330
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0351)
Ankara, 06230
Ankara City Hospital-Infectious Disease and Clinical Microbiology ( Site 0359)
Ankara, 06800
Osmangazi UTF ( Site 0357)
Eskişehir, 26480
Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0355)
Istanbul, 34093
Sisli Hamide Etfal Egitim ve Arastirma Hastanesi ( Site 0358)
Istanbul, 34371
Ege UTF ( Site 0356)
Izmir, 35040
Mexico5 sites
Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 0239)
Aguascalientes, 20259
CHRISTUS - LATAM HUB CENTER OF EXCELLENCE AND INNOVATION S.C. ( Site 0241)
General Escobedo, Nuevo León, 64060
Hospital Civil Fray Antonio Alcalde-pediatrics infectious diseases ( Site 0230)
Guadalajara, Jalisco, 44280
Instituto Nacional de Pediatria ( Site 0231)
Mexico City, Mexico City, 04530
Hospital Infantil de Mexico Federico Gomez ( Site 0227)
Mexico City, Mexico City, 06720
Brazil4 sites
Hospital Pequeno Principe ( Site 0276)
Curitiba, Paraná, 80250-060
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCL-CENTRO DE ESTUDOS E PESQUISAS EM MOLES
Natal, Rio Grande do Norte, 59025-050
Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0277)
Recife, Pernambuco, 50070-902
Instituto D'Or de Pesquisa e Ensino (IDOR)-Hospital São Luiz Jabaquara ( Site 0283)
São Paulo, 04321-120
Georgia4 sites
JSC Evex Hospitals. ( Site 0601)
Batumi, Adjara, 6010
Tbilisi State Medical University G. Zhvania Pediatric Academic Clinic ( Site 0600)
Tbilisi, K'alak'i T'bilisi, 0159
JSC Evex Hospital ( Site 0602)
Tbilisi, 0159
JSC Evex Hospitals ( Site 0603)
Tbilisi, 0159
Guatemala3 sites
Clinica Privada ( Site 0551)
Guatemala City, 01001
Private Practice Mario Melgar ( Site 0552)
Guatemala City, 01009
Private Practice Dra. Manrique ( Site 0553)
Guatemala City, 01010
Lithuania3 sites
Hospital of Lithuanian University of Health Sciences Kaunas ( Site 0701)
Kaunas, 50161
Klaipedos Vaiku Ligonine ( Site 0700)
Klaipėda, 92140
Vaiku ligonine VsI VUL Santaros kliniku filialas ( Site 0702)
Vilnius, 08406
Poland3 sites
Wojewodzki Szpital Obserwacyjno Zakazny ( Site 0429)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030
Wojewodzki Szpital Specjalistyczny im. dr. Wladyslawa Bieganskiego ( Site 0427)
Lodz, Łódź Voivodeship, 91-347
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 0431)
Łomianki, Masovian Voivodeship, 05-092
Russia3 sites
Children s Republican Clinical Hospital ( Site 0512)
Kazan', Tatarstan, Respublika, 420138
City Childrens Clinical Emergency Hospital ( Site 0507)
Novosibirsk, Novosibirsk Oblast, 630007
Smolensk Regional Clinical Hospital ( Site 0511)
Smolensk, Smolensk Oblast, 214018
South Africa3 sites
Enhancing Care Foundation-DICRS ( Site 0381)
Durban, KwaZulu-Natal, 4013
Emmed Research Incorporating ( Site 0377)
Pretoria, Gauteng, 0084
Setshaba Research Centre ( Site 0378)
Pretoria, Gauteng, 0152
Ukraine3 sites
Dnipropetrovsk Oblast Children's Clinical Hospital ( Site 0868)
Dnipro, Dnipropetrovsk Oblast, 49100
SI Dnipropetrovsk Regional Children Clinical Hospital DOR ( Site 0863)
Dnipro, Dnipropetrovsk Oblast, 49100
Ivano-Frankivsk Regional Children Clinical Hospital ( Site 0865)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014
Latvia2 sites
Daugavpils Regional Hospital ( Site 0651)
Daugavpils, 5417
Liepaja Regional Hospital ( Site 0652)
Liepāja, 3414
About this study
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)
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).
Read the 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.
- Being tested
- Tedizolid phosphate, Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tedizolid phosphateDrug
Also called MK-1986, TR-701 FA
Tedizolid phosphate IV solution or oral suspension
ComparatorDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 35 days
Secondary outcomes (2)
Percentage of Participants With Clinical Response (CR) Per Investigator Assessment
CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \& symptoms, absence/near resolution of regional/systemic signs of infection if present at baseline (BL) \& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event (TEAE) leading to study drug discontinuation \& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \& 3 \& all cohorts together were reported, \& failure \& indeterminate responses were pooled.
Measured: Up to approximately 25 days
Percentage of Clinically Evaluable (CE) Participants With CR Per Investigator Assessment
CR was defined as clinical success, failure or indeterminate as per investigator assessment. Success was all of the following: resolution/near resolution of most disease-specific signs \& symptoms, absence/near resolution of regional/systemic signs of infection if present at BL \& no new signs, symptoms, or complications, so, no further antibiotic therapy required. Failure was any of the following: requires additional antibiotic therapy, unplanned major surgical intervention required due to study drug failure, developed osteomyelitis after BL, persistent gram+ bacteremia, treatment emergent adverse event leading to study drug discontinuation \& required additional antibiotic therapy to treat infection or death within 28 days of first infusion. Indeterminate was no efficacy data available. Per protocol, percentage of participants with CR for Cohorts 1, 2 \& 3 and all cohorts together were reported, \& failure \& indeterminate responses were pooled.
Measured: Up to approximately 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Jan 2019
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176134
- Sponsor's protocol ID
- 1986-018
- Other IDs
- MK-1986-018, 2016-003884-20, 2016
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2017
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 40233296