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

Who is this study for? Patients with Methicillin-resistant Staphylococcus Aureus, Skin Infection
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 85
Healthy Volunteers: No
View:

• 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.

Locations
United States
California
Olive View-UCLA Medical Center
Recruiting
Sylmar
Harbor-UCLA Medical Center
Recruiting
Torrance
Missouri
Washington University
Recruiting
Saint Louis
Contact Information
Primary
Donna Phan Tran, MPH
dphantran@lundquist.org
310-222-3775
Time Frame
Start Date: November 26, 2018
Estimated Completion Date: November 1, 2023
Participants
Target number of participants: 462
Treatments
Experimental: Trimethoprim/sulfamethoxazole (TMP-SMX)
TMP-SMX will be dosed as follows: for adults, 160/800 mg administered as two single strength (SS) over-encapsulated tablets (equivalent to one double strength (DS) tablet) twice daily. As dosages of these medications may be lower in children with lower body weight (<40 kg), we will use weight based liquid medications for children < 40 kg (TMP/SMX dosed based on 8-10 mg/kg of TMP daily, divided into two daily doses) for those children who are under 40 kg in weight. As dosages of these medications are higher in persons with high body weight (>100 kg), we will use TMP/SMX 160/800 mg administered as four single strength (SS) over-encapsulated tablets (equivalent to two double strength (DS) tablet) twice daily.
Experimental: Doxycycline (DOXY)
DOXY will be dosed as follows: for adults, two 50 mg tabs (100 mg total) given twice daily. As dosages of these medications may be lower in children with lower body weight (<40 kg), we will use weight based liquid medications for children < 40 kg (DOXY 2.2 mg/kg twice daily) for those children who are under 40 kg in weight. The doxycycline dose will remain the same for persons with high body weight (>100 kg) and four additional placebo tabs will be given to subjects > 100 kg randomized to doxycycline.
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Washington University School of Medicine, University of California, Los Angeles
Leads: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials