Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT03176134
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
11 Years
Study:
NCT03176134
Study Brief:
Protocol Section:
NCT03176134