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:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-24 @ 11:51 AM
NCT ID:
NCT02750761
Eligibility Criteria:
Inclusion Criteria:
* Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity;
* Weight \>5th percentile and \<95th percentile based on age;
* Stable condition as determined from medical history, physical examination, minimally 5-lead electrocardiogram (ECG), vital signs, and clinical laboratory evaluations;
* Females must be premenarchal, abstinent, or practicing an effective method of birth control;
Exclusion Criteria:
* History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the study results;
* Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease;
* History of drug allergy or hypersensitivity to oxazolidinones;
* Pregnant or breast feeding;
* Significant blood loss within 60 days prior to study start;
* Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study.
* Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug.
* Oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.
* Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
11 Years
Study:
NCT02750761
Study Brief:
Protocol Section:
NCT02750761