Doxycycline vs TMP-SMX for Skin Infections
(TODOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of two antibiotics, doxycycline and trimethoprim/sulfamethoxazole, in treating uncomplicated skin infections such as boils or pus-filled infections. The goal is to determine which antibiotic more effectively cures these infections. Individuals with pus-filled skin infections accompanied by redness, swelling, or pain lasting at least 24 hours may qualify for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain medications like warfarin, phenytoin, or methotrexate, among others. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that doxycycline is usually well-tolerated for treating bacterial infections. The FDA has approved it for skin and soft tissue infections, like those in this trial. Some side effects may include nausea and increased sensitivity to sunlight, but serious reactions are rare.
Studies indicate that trimethoprim-sulfamethoxazole (TMP-SMX) can cause skin reactions more often than some other antibiotics. These reactions can include rashes and, in rare cases, more severe issues like Stevens-Johnson syndrome, a serious skin disorder. Despite these risks, TMP-SMX is widely used and often effective for treating skin infections.
Both antibiotics have been used for many years and have known safety profiles, but potential side effects should be considered.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for skin infections, which often include antibiotics like clindamycin or cephalexin, Doxycycline and Trimethoprim-Sulfamethoxazole (TMP-SMX) offer unique benefits. Doxycycline is known for its anti-inflammatory properties, which can be particularly helpful in reducing swelling and redness associated with infections. TMP-SMX targets a broad spectrum of bacteria, making it a versatile option for various types of skin infections. Researchers are excited about these treatments because they offer potential alternatives with different mechanisms of action, which could be more effective or have fewer side effects than current options.
What evidence suggests that this trial's treatments could be effective for uncomplicated skin and soft tissue infections?
This trial will compare the effectiveness of Doxycycline and Trimethoprim-Sulfamethoxazole (TMP-SMX) in treating skin infections. A previous study found Doxycycline effective for skin and soft tissue infections (SSTIs), and the FDA has approved it for this use. Research has also shown that Doxycycline aids in wound healing, benefiting skin infections. Conversely, several studies on TMP-SMX have demonstrated its effectiveness for SSTIs, with 8 out of 10 trials confirming its efficacy. TMP-SMX also outperformed a placebo in improving skin infection outcomes. Both antibiotics have strong evidence supporting their use for skin infections, making them good options for treating these conditions.46789
Who Is on the Research Team?
Loren G Miller
Principal Investigator
The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center
Fritz Stephanie, MD, MSCI, FAAP, FIDSA, FPIDS
Principal Investigator
Washington Univeristy
Are You a Good Fit for This Trial?
This trial is for people aged 9 to 85 with uncomplicated skin and soft tissue infections like boils or cellulitis. Participants must be able to take oral antibiotics, follow the study plan, and not have been hospitalized recently. Women who can get pregnant should use birth control during and after the study. Those with severe health issues or on certain medications cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are treated with either doxycycline or trimethoprim-sulfamethoxazole for uncomplicated skin and soft tissue infections
Follow-up
Participants are monitored for clinical cure and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Doxycycline
- Trimethoprim-Sulfamethoxazole
Doxycycline is already approved in United States, European Union, Canada, Japan for the following indications:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Washington University School of Medicine
Collaborator
University of California, Los Angeles
Collaborator