A Single Center, Prospective Clinical Trial of Intravenous Ertapenem in the Treatment of Hurley Stage II or III Hidradenitis Suppurativa

NCT05255575 | Withdrawn FDA Drug

• 1 other identifier: IRB11628
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 treatment of choice.13 In 2016, Join-Lambert et al investigated the use of intravenous (IV) ertapenem in 30 patients with severe, refractory HS.14 One gram of ertapenem daily for 6 weeks followed by consolidation antibiotics for 6 months demonstrated promising results in severe, recalcitrant HS.14 These patients reported significant improvements in pain, purulent drainage, and a decrease in handicap score.14 Additionally, this technique is less invasive than surgical excision.

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

• HiSCR

  1\. To determine the role of ertapenem in achieving Hidradenitis Suppurativa clinical response (HiSCR) at 6 weeks. HiSCR is defined as HS clinical response of ≥ 50% reduction from baseline in AN (total abscess and inflammatory nodule) count with no increase in abscess or in draining fistula counts.

  6 weeks

Secondary Outcomes (5)

• DLQI

  6 weeks

• WPAI-SHP

  6 weeks

• Labs

  6 weeks

• HS-LASI

  6 weeks

• Ultrasound

  6 weeks

Study Arms (1)

ertapenem treatment

Drug: Ertapenem

Interventions

Ertapenem DRUG

Patients will receive ertapenem therapy.

ertapenem treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HS patients

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Department of Dermatology, Henry Ford Medical Center, 3031 West Grand Boulevard,

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Ertapenem

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 24, 2022
• Study Start: March 1, 2018
• Primary Completion: July 7, 2019
• Study Completion: August 7, 2019
• Last Updated: February 24, 2022

Record last verified: 2022-02

Locations

US (1)