Doxycycline vs TMP-SMX for Skin Infections
(TODOS Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byFritz Stephanie, MD, MSCI, FAAP, FIDSA, FPIDS

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

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

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

I had staph antibiotics recently due to a skin infection that either came back or didn't fully heal.

I am between 9 and 85 years old.

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Exclusion Criteria

Heart rate less than 45 beats per minute (BPM)

I have not been hospitalized in the last 2 weeks.

Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) less than 35.5° C (95.9° F)

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Treatment Details

Interventions

Doxycycline (Antibiotic)
Trimethoprim-Sulfamethoxazole (Antibiotic)

Trial OverviewThe trial compares two antibiotics: doxycycline (DOXY) and trimethoprim-sulfamethoxazole (TMP/SMX), to see which one better treats simple skin infections that show signs like redness, swelling, warmth, pus drainage, or pain.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Trimethoprim/sulfamethoxazole (TMP-SMX)Experimental Treatment1 Intervention

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.

Group II: Doxycycline (DOXY)Experimental Treatment1 Intervention

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.

Doxycycline is already approved in Canada, Japan for the following indications: