Status:
WITHDRAWN
A Single Center, Prospective Clinical Trial of Intravenous Ertapenem in the Treatment of Hurley Stage II or III Hidradenitis Suppurativa
Lead Sponsor:
Henry Ford Health System
Conditions:
Hidradenitis Suppurativa
Eligibility:
All Genders
18+ years
Brief Summary
: Treatment of chronic, recalcitrant HS presents significant challenges and frustration to both the patient and the provider. In chronic, recalcitrant HS, wide surgical excision is considered the trea...
Detailed Description
Hidradenitis suppurativa (HS) is a chronic, socially and cosmetically debilitating disease characterized by recurrent abscesses, draining sinus tracts, and scarring with a predilection for intertrigin...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Diagnosis of Hurley Stage II or III HS
- Be otherwise healthy with no history of renal impairment
- Participant must be able to understand the requirements of the study and risks involved
- Participant must be able to sign a consent form
- Baseline abscess and inflammatory nodule count (AN count) of 3 or more and draining fistula count of 20 or fewer
- Unresponsive or intolerant to oral antibiotics for HS treatment as determined by the caregiver
- Patient must be unstable with worsening inflammatory manifestations of HS
- Diagnosis of HS for at least 6 mo (180 day) before baseline that involves at least 2 distinct anatomical areas (ex: left and right axillae)
Exclusion
- Any reason the investigator feels the patient should not participate in the study.
- If a patient misses ≥ 2 consecutive study visits, the patient will be excluded from further participation in this trial.
- History of an allergy to an antibiotic in the penicillin class.
- If the investigator feels that a different therapeutic option would be more beneficial to the patient
- Any other skin disease or condition (e.g. infectious or non-infectious) that may interfere with assessment of HS.
- History of any medical condition, in the opinion of the investigator, that would put the subject at risk by participating in this study.
- Subjects who have received biologic medications must wait 3 weeks or 21 days prior to enrollment in this research study.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05255575
Start Date
March 1 2018
End Date
August 7 2019
Last Update
February 24 2022
Active Locations (1)
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1
Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,
Detroit, Michigan, United States, 48202