Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Soft Tissue Infections Treatment

Completed · Phase 2

Conditions studied: Methicillin-resistant Staphylococcus Aureus, Skin Infection

In brief

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.

Key facts

Study ID

NCT03637400

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

269

Starts

2018-11-26

Expected to finish

2025-06-30

Last updated by the study team

2025-12-04

Who can join

Age: 9 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Tenderness to palpation or pain
• Pus or drainage from wound that can be sent for clinical culture
• Able to take oral antibiotic therapy, either in pill or suspension form
• For women of childbearing potential, the participant agrees to use birth control for the 7 days on the study medication and 7 days after completion of study medication
• Patients who have received prior antibacterial therapy with anti-staphylococcal activity within the prior 14 days:
• Received prior systemic antibacterial therapy with anti-staphylococcal activity for a skin infection and are not on it currently, and have relapse/recurrence of skin infection.
• Received prior systemic antibacterial therapy with anti-staphylococcal activity for a skin infection (including those currently on it) without adequate source control of their skin infection and lack of response (i.e., persistence or progression of the lesion) to pre-study antibacterial therapy with on-going evidence of skin infection.
• Received prior antibiotics with anti-staphylococcal activity for non-skin infections and who developed a skin infection while on these antibiotics or shortly after completing these antibiotics.

You may not qualify if…

• 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
• Previous enrollment in this protocol
• Participation in another clinical trial within the previous 30 days
• Superficial skin infection only, including
• Impetigo
• Ecthyma
• Folliculitis
• Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
• Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements
• Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements
• Systolic blood pressure > 180 mm Hg
• Systolic blood pressure (SBP) less than an age-specific critical value:
• Age 9 to 17 years: < 90 mm Hg
• Age ≥ 18 years: < 90 mm Hg
• Heart rate less than 45 beats per minute (BPM)
• Heart rate greater than an age-specific-critical value:
• Age 9 to 17 years: > 120 BPM
• Age ≥ 18 years: > 120 BPM
• Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) less than 35.5° C (95.9° F)
• Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) greater than age-specific critical value:
• Age 9 to 17 years: > 38.5° C (101.3° F)

Where it is running

• Olive View-UCLA Medical Center — Sylmar, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Washington University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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