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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03964493
Eligibility Criteria:
Inclusion Criteria:
* Subjects may be included in the study if they meet all of the following inclusion criteria:
* Males or females, 18 years of age or older;
* ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:
* Cellulitis/erysipelas;
* Wound infection;
* Major cutaneous abscess;
* Lesion with a minimum surface area of 75 cm2;
* Capable of giving signed informed consent.
Exclusion Criteria:
* Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
* History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;
* ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;
* Prior administration of systemic antibacterial therapy within 96 hours before randomization;
* ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;
* ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;
* Evidence of significant hepatic, hematologic, or immunologic disease;
* History or evidence of severe renal disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03964493
Study Brief:
Protocol Section:
NCT03964493