Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Sof… (NCT03637400) | Clinical Trial Compass
CompletedPhase 2
Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Soft Tissue Infections Treatment
United States269 participantsStarted 2018-11-26
Plain-language summary
The purpose of this study is to compare how well two different antibiotics, doxycycline (DOXY) and trimethoprim/sulfamethoxazole (TMP/SMX), work at curing uncomplicated skin and soft tissue infection (uSSTI) such as 1.Boils (pus in the skin, also known as abscesses and furuncles) or 2. Infections that appear only on the skin surface (called cellulitis and erysipelas) that have pus.
Who can participate
Age range9 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 9 years to 85 years
✓. Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 9 and older
✓. Willing and able to complete the study protocol, study-related activities, and visits
✓. Diagnosis of uSSTI, either purulent cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
✓. Erythema
✓. Swelling or induration
✓. Local warmth
✓. Purulent drainage
Exclusion criteria
✕. Cellulitis without abscess, drainage, or other culturable exudate.
✕. Hospital inpatient
✕. Hospitalization within the prior 14 days
✕. Residence in a long-term skilled nursing facility
✕. Requirement for hospitalization for skin infection or other condition
What they're measuring
1
Clinical cure at Early Clinical Response (ECR) visit
Timeframe: Day 2-3 (48-72 hours)
Trial details
NCT IDNCT03637400
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center