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Antibiotic

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

Phase 2

Recruiting

Led By Loren G Miller, MD

Research Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 9 years to 85 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 2-3 (48-72 hours)

Awards & highlights

TODOS Trial Summary

This trial will compare DOXY to TMP/SMX in terms of safety and efficacy for the treatment of uSSTI.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Possible side effects of DOXY include sun sensitivity, stomach upset, teeth discoloration in children; TMP/SMX may cause rash, nausea, blood disorders or kidney issues. Allergic reactions are also a risk with both drugs.

TODOS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 9 and 85 years old.

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I have a skin infection with redness, swelling, warmth, or pus.

TODOS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 2-3 (48-72 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 2-3 (48-72 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 2-3 (48-72 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical cure at Early Clinical Response (ECR) visit

Secondary outcome measures

Adverse events

Adverse events that are treatment limiting

Clinical cure at the End of Treatment (EOT) visit

+4 more

TODOS Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor

101 Previous Clinical Trials

45,839 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)NIH

3,269 Previous Clinical Trials

5,481,007 Total Patients Enrolled

1 Trials studying MRSA

65 Patients Enrolled for MRSA

Washington University School of MedicineOTHER

1,935 Previous Clinical Trials

2,299,345 Total Patients Enrolled

1 Trials studying MRSA

33 Patients Enrolled for MRSA

Media Library

MRSA Research Study Groups: Trimethoprim/sulfamethoxazole (TMP-SMX), Doxycycline (DOXY)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which patients would be a good match for this type of treatment?

"462 patients that suffer from skin diseases, both infectious and non-infectious, between the ages of 9 to 85 years old are being enrolled in this study. There are a few requirements that participants must meet which include: the ability to commit to the protocol, related activities, and visits; erythema, swelling or induration; purulent drainage; tenderness to palpation or pain; pus or drainage from wound for clinical culture."

Answered by AI

Has the FDA given their okay to DOXY?

"While Phase 2 trials don't have efficacy data, DOXY's safety was supported by some clinical evidence, giving it a score of 2."

Answered by AI

How many individuals can join this clinical trial at its maximum capacity?

"That is correct. The table on clinicaltrials.gov says that the study, which was first advertised on November 26th 2018, is still recruiting patients. They are looking for 462 individuals who are willing to participate at 3 different trial locations."

Answered by AI

Does this study have an age limit of 85 years or younger?

"To be qualified for this particular clinical trial, applicants must fall between the ages of 9 and 85. Out of the 915 total studies, 230 are for people under 18 years old and 685 are for those over 65."

Answered by AI

Are there any precedents for using DOXY in clinical trials?

"DOXY was first studied a decade ago at McMaster Children's Hospital. There have been a total of 238 completed trials to date. Currently, there are 53 live clinical trials being conducted; many in Sylmar, California."

Answered by AI

Are patients able to join this clinical trial at this time?

"This trial, as seen on clinicaltrials.gov, is open for recruitment. The first posting was on November 26th 2018 with the most recent update happening July 1st 2021."

Answered by AI