Methicillin-resistant Staphylococcus AureusPhase 2TODOSNCT03637400
Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Skin and Soft Tissue Infections Treatment
A Phase 2 study testing TMP-SMX and DOXY in people with Methicillin-resistant Staphylococcus Aureus and Skin Infection, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 85 years
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus, Skin Infection
- What is being tested?
- TMP-SMX and DOXY
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Nov 2018to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 9 years to 85 years
- Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 9 and older
- Willing and able to complete the study protocol, study-related activities, and visits
- 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
Show all 16Show fewer
- Local warmth
- Purulent drainage
- Tenderness to palpation or pain
- Pus or drainage from wound that can be sent for clinical culture
- Able to take oral antibiotic therapy, either in pill or suspension form
- 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
- Patients who have received prior antibacterial therapy with anti-staphylococcal activity within the prior 14 days:
- Received prior systemic antibacterial therapy with anti-staphylococcal activity for a skin infection and are not on it currently, and have relapse/recurrence of skin infection.
- Received prior systemic antibacterial therapy with anti-staphylococcal activity for a skin infection (including those currently on it) without adequate source control of their skin infection and lack of response (i.e., persistence or progression of the lesion) to pre-study antibacterial therapy with on-going evidence of skin infection.
- Received prior antibiotics with anti-staphylococcal activity for non-skin infections and who developed a skin infection while on these antibiotics or shortly after completing these antibiotics.
Who cannot join
- Cellulitis without abscess, drainage, or other culturable exudate.
- Hospital inpatient
- Hospitalization within the prior 14 days
- Residence in a long-term skilled nursing facility
- Requirement for hospitalization for skin infection or other condition
- Previous enrollment in this protocol
Show all 58Show fewer
- Participation in another clinical trial within the previous 30 days
- Superficial skin infection only, including
- Impetigo
- Ecthyma
- Folliculitis
- Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
- Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements
- Systolic blood pressure > 180 mm Hg
- Systolic blood pressure (SBP) less than an age-specific critical value:
- Age 9 to 17 years: < 90 mm Hg
- Age ≥ 18 years: < 90 mm Hg
- Heart rate less than 45 beats per minute (BPM)
- Heart rate greater than an age-specific-critical value:
- Age 9 to 17 years: > 120 BPM
- Age ≥ 18 years: > 120 BPM
- Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) less than 35.5° C (95.9° F)
- Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) greater than age-specific critical value:
- Age 9 to 17 years: > 38.5° C (101.3° F)
- Age ≥ 18 years: > 38.5° C (101.3° F)
- Documented human or witnessed animal bite in the past 30 days at the site of infection
- Received prior systemic antibacterial therapy with anti-staphylococcal activity within the prior 14 days who do not meet inclusion criteria 8, 9 and 10.
- The following concomitant medications: warfarin, phenytoin, methotrexate, dofetilide, methanamine, amiodarone, leucovorin, pyrimethamine, acitretin, atovaquone, atovaquone/proguanil, isotretinoin, or sulfonylureas and systemically administered antibacterial agents with activity against staphylococci
- Diagnosed or suspected disseminated or severe S. aureus or GAS infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious or infections
- Infection at an anatomical site skin requiring specialized management or specialized antimicrobial therapy, including
- Periauricular or orbital infection
- Perirectal infection
- Suspected deep space infection of the hand or foot
- Genital infection
- Mastitis
- Bursitis
- Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician)
- Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics
- Hypersensitivity or history of allergic reaction to study drug
- History of G6PD deficiency
- Pregnant or lactating, or intending to become pregnant within 3 months after screening Women of childbearing potential must have a negative urine or serum pregnancy test result within 1 day prior to initiation of study drug.
- Severe or morbid obesity with a body mass index (BMI) >45 kg/m2; patients above BMI >45 can be enrolled if their weight is < 100 kg kg/m2.
- Complicated skin or soft tissue infection, such as
- Catheter or catheter site infection within 30 days of placement
- Surgical site infection
- Known or suspected prosthetic device infection
- Suspected Gram-negative or anaerobic pathogen
- Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc)
- History of drug-induced thrombocytopenia and documented megaloblastic anemia due to folate deficiency.
- Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis
- History of severe underlying immunocompromising condition or immunodeficiency, for example
- Chronic renal failure, creatinine clearance <30 ml/min
- Renal dialysis within the past 180 days
- HIV-positive with either CD4 count <200 or <4% CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months
- Cancer or malignancy with receipt of systemic chemotherapy in the prior 180 days
- Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease
- Other serious underlying disease, as determined by the treating physician or the investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Washington University
St Louis, Missouri, 63130
Olive View-UCLA Medical Center
Sylmar, California, 91342
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Treatment of Uncomplicated Skin and Soft Tissue Infections
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.
Read the detailed description
This is a phase IIb multicenter, randomized, double-blind trial in which enrolled subjects with abscess or cellulitis will be treated with either DOXY or TMP-SMX.
The overall objective is to provide a clinically relevant treatment strategy for uSSTI in children and adults in areas where CA-MRSA is prevalent. Out-patient subjects, both children and adults with abscess and/or purulent cellulitis will be enrolled into a randomized, double-blind trial in which enrolled subjects will be treated with either DOXY or TMP-SMX.
Background: Staphylococcus aureus is the most commonly identified cause of skin infections. In the last 15 years, there also has been an large increase in Staphylococcus aureus skin infection attributable to CA-MRSA (Methicillin-resistant Staphylococcus aureus) throughout the United States. However, optimal treatment remains unclear and several commonly used antibiotics such as doxycycline are commonly used but understudied. As resistance among CA-MRSA strains to commonly used antibiotics such as clindamycin continues to increase, there is a need to understand the relative safety and efficacy of alternative treatments, such as doxycycline. This clinical trial will evaluate DOXY and TMP-SMX for the outpatient management of uSSTI in two metropolitan areas, Los Angeles and St. Louis, cities with high prevalence of CA-MRSA. This trial will test important unanswered hypotheses relating to the treatment of CA-MRSA uSSTI and it will advance healthcare providers' ability to successfully manage adults and children with uSSTIs in areas where CA-MRSA is prevalent.
Methods: Out-patient subjects, both children and adults with abscess and/or purulent cellulitis will be enrolled into a randomized, double-blind trial in which enrolled subjects will be treated with either DOXY or TMP-SMX. Using a 1:1 randomized controlled trial of 462 subjects, the investigators aim to 1) compare the cure rate of DOXY to that of TMP-SMX for the treatment of patients throughout the study 2) compare rates of adverse events and of adverse events that are treatment limiting between DOXY and TMP-SMX 3) estimate relapse and recurrence of uSSTI among patients treated with DOXY and of TMP-SMX 4) estimate treatment failure among patients with uSSTI colonized with S. aureus at the anterior nares and oropharynx.
- Being tested
- TMP-SMX, DOXY
- Medical subject headings
- Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMP-SMXDrug
Also called Trimethoprim/sulfamethoxazole
TMP-SMX will be administered over a period of 7 days.
DOXYDrug
Also called Doxycycline
DOXY will be administered over a period of 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Trimethoprim/sulfamethoxazole (TMP-SMX) | Experimental | 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. Receives: Drug: TMP-SMX |
| Doxycycline (DOXY) | Experimental | 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. Receives: Drug: DOXY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure at Early Clinical Response (ECR) visit
Clinical cure is the absence of clinical failure which is defined as occurrence of any one of the following events at ECR:
- Fever (one or more temperature readings of ≥37.7°C between 48 and 72 hours);
- Spread of lesion defined as an increase in size (length, width, or area) of the redness, edema, and/or induration such that the size of the lesion is greater than the size at baseline;
- Administration of rescue antibacterial drug therapy or any non-trial antibacterial drug therapy for the treatment of SSTI prior to the ECR evaluation;
- Requires an additional unplanned surgical procedure after start of therapy;
- Death.
Measured: Day 2-3 (48-72 hours)
Secondary outcomes (7)
Clinical cure at the End of Treatment (EOT) visit
Clinical cure will be defined as complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
Measured: Day 7
Clinical cure at the One Month Follow-up (OMFU) visit
Clinical cure will be defined as complete or nearly complete resolution of baseline signs and symptoms of the primary infection such that no further treatment with antibiotics is needed
Measured: Day 37
Adverse events
An adverse event (AE) is defined as any unfavorable or undesirable effect (sign, symptom, laboratory abnormality, or condition), regardless of causal relationship to study procedures or participation that occurs in a subject while enrolled in this clinical trial. Any medical condition that is present at the time that the subject is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. The occurrence of an AE may come to the attention of study personnel during study visits and interviews of a study recipient presenting for medical care, or upon review by a study monitor.
Measured: Day 0-365
Adverse events that are treatment limiting
An adverse event (AE) is defined as any unfavorable or undesirable effect (sign, symptom, laboratory abnormality, or condition), regardless of causal relationship to study procedures or participation that occurs in a subject while enrolled in this clinical trial. Any medical condition that is present at the time that the subject is screened should be considered as baseline and not reported as an AE. However, if it deteriorates at any time during the study, it should be recorded as an AE. The occurrence of an AE may come to the attention of study personnel during study visits and interviews of a study recipient presenting for medical care, or upon review by a study monitor.
Measured: Day 0-365
Relapse/recurrent SSTI at One Month Follow-Up (OMFU)
Relapse will be defined as a return of the original infection after initial improvement prior to or at the OMFU visit. Recurrence will be defined as a return of skin infection at the original site, even if considered to be a separate occurrence, after the OMFU visit or a skin infection at a new site of infection.
Measured: Day 37
Relapse/recurrent SSTI at 6 Month Follow-Up (6MFU)
Relapse will be defined as a return of the original infection after initial improvement prior to or at the 6MFU visit. Recurrence will be defined as a return of skin infection at the original site, even if considered to be a separate occurrence, after the 6MFU visit or a skin infection at a new site of infection.
Measured: Day 180
Relapse/recurrent SSTI at 12 Month Follow-Up (12MFU)
Relapse will be defined as a return of the original infection after initial improvement prior to or at the 12MFU visit. Recurrence will be defined as a return of skin infection at the original site, even if considered to be a separate occurrence, after the 12MFU visit or a skin infection at a new site of infection.
Measured: Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start26 Nov 2018
- Primary completion12 Feb 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Washington University School of Medicine, University of California, Los Angeles
- Responsible party
- Principal investigator, loren g miller, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Loren G Miller, MD, MPH, Principal investigator, The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical CenterFritz Stephanie, MD, MSCI, FAAP, FIDSA, FPIDS, Principal investigator, Washington Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637400
- Sponsor's protocol ID
- 30284
- Acronym
- TODOS
- Status last verified
- Nov 2025
- First submitted
- 8 Aug 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chambers HF. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis. 2001 Mar-Apr;7(2):178-82. doi: 10.3201/eid0702.010204.
PubMed 11294701Gorak EJ, Yamada SM, Brown JD. Community-acquired methicillin-resistant Staphylococcus aureus in hospitalized adults and children without known risk factors. Clin Infect Dis. 1999 Oct;29(4):797-800. doi: 10.1086/520437.
PubMed 10589891Herold BC, Immergluck LC, Maranan MC, Lauderdale DS, Gaskin RE, Boyle-Vavra S, Leitch CD, Daum RS. Community-acquired methicillin-resistant Staphylococcus aureus in children with no identified predisposing risk. JAMA. 1998 Feb 25;279(8):593-8. doi: 10.1001/jama.279.8.593.
PubMed 9486753Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus skin or soft tissue infections in a state prison--Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 2001 Oct 26;50(42):919-22.
PubMed 11699844Centers for Disease Control and Prevention (CDC). Outbreaks of community-associated methicillin-resistant Staphylococcus aureus skin infections--Los Angeles County, California, 2002-2003. MMWR Morb Mortal Wkly Rep. 2003 Feb 7;52(5):88.
PubMed 12588006Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus infections in correctional facilities---Georgia, California, and Texas, 2001-2003. MMWR Morb Mortal Wkly Rep. 2003 Oct 17;52(41):992-6.
PubMed 14561958Centers for Disease Control and Prevention (CDC). Methicillin-resistant staphylococcus aureus infections among competitive sports participants--Colorado, Indiana, Pennsylvania, and Los Angeles County, 2000-2003. MMWR Morb Mortal Wkly Rep. 2003 Aug 22;52(33):793-5.
PubMed 12931079Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus skin infections among tattoo recipients--Ohio, Kentucky, and Vermont, 2004-2005. MMWR Morb Mortal Wkly Rep. 2006 Jun 23;55(24):677-9.
PubMed 16791134Adcock PM, Pastor P, Medley F, Patterson JE, Murphy TV. Methicillin-resistant Staphylococcus aureus in two child care centers. J Infect Dis. 1998 Aug;178(2):577-80. doi: 10.1086/517478.
PubMed 9697748Ellis MW, Hospenthal DR, Dooley DP, Gray PJ, Murray CK. Natural history of community-acquired methicillin-resistant Staphylococcus aureus colonization and infection in soldiers. Clin Infect Dis. 2004 Oct 1;39(7):971-9. doi: 10.1086/423965. Epub 2004 Sep 2.
PubMed 15472848
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Outcomes of Doxycycline Versus Trimethoprim-Sulfamethoxazole for Treatment of Uncomplicated Skin and Soft Tissue Infections
- ClinicalTrials.gov ID
- NCT03637400
- Acronym / sponsor ID
- TODOS / 30284
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Washington University School of Medicine, University of California, Los Angeles
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase IIb multicenter, randomized, double-blind trial in which enrolled subjects with abscess or cellulitis will be treated with either DOXY or TMP-SMX.
The overall objective is to provide a clinically relevant treatment strategy for uSSTI in children and adults in areas where CA-MRSA is prevalent. Out-patient subjects, both children and adults with abscess and/or purulent cellulitis will be enrolled into a randomized, double-blind trial in which enrolled subjects will be treated with either DOXY or TMP-SMX.
Background: Staphylococcus aureus is the most commonly identified cause of skin infections. In the last 15 years, there also has been an large increase in Staphylococcus aureus skin infection attributable to CA-MRSA (Methicillin-resistant Staphylococcus aureus) throughout the United States. However, optimal treatment remains unclear and several commonly used antibiotics such as doxycycline are commonly used but understudied. As resistance among CA-MRSA strains to commonly used antibiotics such as clindamycin continues to increase, there is a need to understand the relative safety and efficacy of alternative treatments, such as doxycycline. This clinical trial will evaluate DOXY and TMP-SMX for the outpatient management of uSSTI in two metropolitan areas, Los Angeles and St. Louis, cities with high prevalence of CA-MRSA. This trial will test important unanswered hypotheses relating to the treatment of CA-MRSA uSSTI and it will advance healthcare providers' ability to successfully manage adults and children with uSSTIs in areas where CA-MRSA is prevalent.
Methods: Out-patient subjects, both children and adults with abscess and/or purulent cellulitis will be enrolled into a randomized, double-blind trial in which enrolled subjects will be treated with either DOXY or TMP-SMX. Using a 1:1 randomized controlled trial of 462 subjects, the investigators aim to 1) compare the cure rate of DOXY to that of TMP-SMX for the treatment of patients throughout the study 2) compare rates of adverse events and of adverse events that are treatment limiting between DOXY and TMP-SMX 3) estimate relapse and recurrence of uSSTI among patients treated with DOXY and of TMP-SMX 4) estimate treatment failure among patients with uSSTI colonized with S. aureus at the anterior nares and oropharynx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trimethoprim/sulfamethoxazole (TMP-SMX) | Experimental | Drug: TMP-SMXTMP-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. |
| Doxycycline (DOXY) | Experimental | Drug: DOXYDOXY 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. |
Who may qualify
- Ages
- 9 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Age 9 years to 85 years
- Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 9 and older
- Willing and able to complete the study protocol, study-related activities, and visits
- 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:
- Pus or drainage from wound that can be sent for clinical culture
Key exclusion criteria (58 listed)
- Cellulitis without abscess, drainage, or other culturable exudate.
- Hospital inpatient
- Hospitalization within the prior 14 days
- Residence in a long-term skilled nursing facility
- Requirement for hospitalization for skin infection or other condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMP-SMXAlso: Trimethoprim/sulfamethoxazoleTMP-SMX will be administered over a period of 7 days. | Drug | Trimethoprim/sulfamethoxazole (TMP-SMX) |
| DOXYAlso: DoxycyclineDOXY will be administered over a period of 7 days. | Drug | Doxycycline (DOXY) |
Primary outcome
Clinical cure at Early Clinical Response (ECR) visit
Time frame: Day 2-3 (48-72 hours)
Clinical cure is the absence of clinical failure which is defined as occurrence of any one of the following events at ECR: * Fever (one or more temperature readings of ≥37.7°C between 48 and 72 hours); * Spread of lesion defined as an increase in size (length, width, or area) of the redness, edema, and/or induration such that the size of the lesion is greater than the size at baseline; * Administration of rescue antibacterial drug therapy or any non-trial antibacterial drug therapy for the treatment of SSTI prior to the ECR evaluation; * Requires an additional unplanned surgical procedure after start of therapy; * Death.
7 secondary outcomes
Clinical cure at the End of Treatment (EOT) visit
Time frame: Day 7
Clinical cure at the One Month Follow-up (OMFU) visit
Time frame: Day 37
Adverse events
Time frame: Day 0-365
Adverse events that are treatment limiting
Time frame: Day 0-365
Relapse/recurrent SSTI at One Month Follow-Up (OMFU)
Time frame: Day 37
Relapse/recurrent SSTI at 6 Month Follow-Up (6MFU)
Time frame: Day 180
Relapse/recurrent SSTI at 12 Month Follow-Up (12MFU)
Time frame: Day 365
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 11294701Chambers HF. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis. 2001 Mar-Apr;7(2):178-82. doi: 10.3201/eid0702.010204.
- Background: PubMed 10589891Gorak EJ, Yamada SM, Brown JD. Community-acquired methicillin-resistant Staphylococcus aureus in hospitalized adults and children without known risk factors. Clin Infect Dis. 1999 Oct;29(4):797-800. doi: 10.1086/520437.
- Background: PubMed 9486753Herold BC, Immergluck LC, Maranan MC, Lauderdale DS, Gaskin RE, Boyle-Vavra S, Leitch CD, Daum RS. Community-acquired methicillin-resistant Staphylococcus aureus in children with no identified predisposing risk. JAMA. 1998 Feb 25;279(8):593-8. doi: 10.1001/jama.279.8.593.
- Background: PubMed 11699844Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus skin or soft tissue infections in a state prison--Mississippi, 2000. MMWR Morb Mortal Wkly Rep. 2001 Oct 26;50(42):919-22.
- Background: PubMed 12588006Centers for Disease Control and Prevention (CDC). Outbreaks of community-associated methicillin-resistant Staphylococcus aureus skin infections--Los Angeles County, California, 2002-2003. MMWR Morb Mortal Wkly Rep. 2003 Feb 7;52(5):88.
- Background: PubMed 14561958Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus infections in correctional facilities---Georgia, California, and Texas, 2001-2003. MMWR Morb Mortal Wkly Rep. 2003 Oct 17;52(41):992-6.
- Background: PubMed 12931079Centers for Disease Control and Prevention (CDC). Methicillin-resistant staphylococcus aureus infections among competitive sports participants--Colorado, Indiana, Pennsylvania, and Los Angeles County, 2000-2003. MMWR Morb Mortal Wkly Rep. 2003 Aug 22;52(33):793-5.
- Background: PubMed 16791134Centers for Disease Control and Prevention (CDC). Methicillin-resistant Staphylococcus aureus skin infections among tattoo recipients--Ohio, Kentucky, and Vermont, 2004-2005. MMWR Morb Mortal Wkly Rep. 2006 Jun 23;55(24):677-9.
- Background: PubMed 9697748Adcock PM, Pastor P, Medley F, Patterson JE, Murphy TV. Methicillin-resistant Staphylococcus aureus in two child care centers. J Infect Dis. 1998 Aug;178(2):577-80. doi: 10.1086/517478.
- Background: PubMed 15472848Ellis MW, Hospenthal DR, Dooley DP, Gray PJ, Murray CK. Natural history of community-acquired methicillin-resistant Staphylococcus aureus colonization and infection in soldiers. Clin Infect Dis. 2004 Oct 1;39(7):971-9. doi: 10.1086/423965. Epub 2004 Sep 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loren G Miller, MD, MPH principal investigator
The Lundquist Institute For Biomedical Innovation at Harbor-UCLA Medical Center
Fritz Stephanie, MD, MSCI, FAAP, FIDSA, FPIDS principal investigator
Washington Univeristy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMP-SMX and DOXY in people with Methicillin-resistant Staphylococcus Aureus and Skin Infection, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 58 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure at Early Clinical Response (ECR) visit (time frame: Day 2-3 (48-72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03637400, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.