Wound Infection Clinical Trial
Official title:
A Phase 2, Open-Label, Multi-Center Study of Safety, Tolerability, and Efficacy of AFN-12520000 in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococci
The purpose of the study is to determine the safety, tolerability and effectiveness of AFN-12520000 for in the treatment of Staphylococcal infections of the skin.
This open-label Phase 2 study is designed as a proof-of-concept study to evaluate the
efficacy of a total daily dose of 400 mg of AFN-12520000 using a number of newly defined
early endpoints, conventional endpoints, and composite endpoints to determine clinical
response. Safety and tolerability will also be evaluated by conventional endpoints.
The study will enroll up to 100 patients with a clinically documented diagnosis of Acute
Bacterial Skin and Skin Structure Infections (ABSSSI) due to staphylococci. Patients meeting
eligibility criteria will be identified and evaluated in a hospital or specialized clinic.
After consent is obtained, the first dose of study medication will be administered. Daily
clinical assessments will be conducted at the hospital and/or outpatient clinic during the
first 5 days of treatment. Adverse events (AEs) and response to therapy will also be
assessed.
The study will consist of a screening period, which includes the baseline visit; a treatment
period, and an end-of-treatment (EOT) visit; and a follow-up period, which includes a
short-term (Test-of-Cure [TOC]) follow-up (STFU/TOC) visit and a long-term follow-up (LTFU)
visit.
Treatment regimens as short as 5 days (10 doses) and as long as 14 days (28 doses) will be
permitted depending on individual response to treatment. The anticipated time commitment for
patient participation in the study will be approximately 20 to 42 days from
screening/baseline to the LTFU visit. The total duration of the study will be < 12 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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