# Short and long term outcomes of doxycycline versus TMP-SMX for SSTI treatment

> **NIH NIH U01** · LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER · 2022 · $1,002,378

## Abstract

Project Summary / Abstract
 Community-associated (CA) skin and soft tissue infections (SSTIs) pose a substantial health burden
worldwide. SSTI incidence in the U.S. has increased 50% in the past decade resulting in over 10 million visits
to healthcare providers annually. This increase is driven by the emergence of community-associated
methicillin-resistant Staphylococcus aureus (MRSA) strains, which now cause the majority of SSTIs. No other
infectious disease has seen such a dramatic rise. Of great concern is that SSTIs are complicated by high rates
of recurrence (>50% in 1 year), as well as hospitalization, severe sepsis, and even death.
 Current guidelines inadequately address the role of older, inexpensive antibiotics for SSTI treatment.
The disconnect between the high incidence of SSTIs, which exceed that of pneumonia and urinary tract
infections, and the lack of data to guide prescribing physicians is unjustifiable and can only be addressed by
high quality clinical trials. Recent studies have demonstrated that clindamycin and trimethoprim-
sulfamethoxazole (TMP-SMX) have similar efficacy and safety for uncomplicated SSTIs (uSSTIs). Both have
efficacy, when combined with incision and drainage, that exceeds that of placebo. However, clindamycin
resistance among S. aureus in the U.S. is increasing and exceeds 90% in some parts of the world. TMP-SMX
is also limited by higher rates of recurrent SSTIs compared to clindamycin and by emergence of TMP-SMX
resistance among S. aureus in populations where use of TMP-SMX is high.
 Doxycycline is the natural choice for study of uSSTI treatment. Its tolerability, low cost, and promising
preliminary data for SSTI management suggest it is efficacious and safe for uSSTI treatment. Unfortunately,
high quality comparative effectiveness data for SSTI treatment with doxycycline are lacking.
 We will perform a clinical trial of uSSTIs, targeting infections likely to be caused by CA-MRSA and
populations previously ignored in other trials of SSTIs (e.g., diabetics, obese persons). We will compare the
efficacy and safety of doxycycline versus TMP-SMX for the treatment of suppurative uSSTI in older children
and adults. We will also compare efficacy of preventing recurrent uSSTIs up to 12 months after initial treatment
and define the relationship between nasal and oropharyngeal colonization and treatment success and
recurrence. We will quantify and characterize emergent colonizing antibiotic-resistant S. aureus isolates.
Finally, we will develop a new clinical trial outcome for SSTIs using the Desirability Of Outcome Ranking
(DOOR) design for this trial. This outcome will complement our more traditional primary outcome by capturing
meaningful patient-centered outcomes. DOOR outcomes can reduce sample size of future SSTI clinical trials,
thus making future trials less expensive and more feasible. Our investigation will be critical in defining the role
of doxycycline for uSSTI treatment and lay the foundation for evidenc...

## Key facts

- **NIH application ID:** 10457315
- **Project number:** 5U01AI116400-05
- **Recipient organization:** LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
- **Principal Investigator:** LOREN G. MILLER
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,002,378
- **Award type:** 5
- **Project period:** 2018-07-16 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10457315

## Citation

> US National Institutes of Health, RePORTER application 10457315, Short and long term outcomes of doxycycline versus TMP-SMX for SSTI treatment (5U01AI116400-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10457315. Licensed CC0.

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