Doxycycline vs TMP-SMX for Skin Infections
(TODOS Trial)
Trial Summary
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.
What data supports the effectiveness of the drug Doxycycline for skin infections?
A study found that doxycycline was effective for treating skin and soft tissue infections, with a clinical failure rate of 9% in the trimethoprim-sulfamethoxazole group, but no significant difference in failure rates between the two drugs. Doxycycline is also widely used for other bacterial infections, which supports its effectiveness.12345
Is Doxycycline or TMP-SMX generally safe for treating skin infections?
Doxycycline is known for its excellent safety profile and is widely used for various infections. However, Trimethoprim-Sulfamethoxazole (TMP-SMX) can have adverse effects, especially in people with kidney or heart issues, and may cause serious side effects like hyperkalemia (high potassium levels in the blood).12346
How does the drug Doxycycline differ from other treatments for skin infections?
Doxycycline is unique for its intracellular mechanism of action, excellent safety profile, and low cost, making it a widely used antibiotic for various infections, including skin infections. Unlike TMP-SMX, which has a higher clinical failure rate in some cases, doxycycline is effective against methicillin-resistant Staphylococcus aureus (MRSA) and is often used when other options are limited.13478
What is the purpose of this trial?
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.
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
Eligibility Criteria
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
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
Treatment Details
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