Methicillin-resistant Staphylococcus Aureus Clinical Trial
— TODOSOfficial 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.
Status | Recruiting |
Enrollment | 462 |
Est. completion date | November 1, 2025 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. Age 9 years to 85 years 2. 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 3. Willing and able to complete the study protocol, study-related activities, and visits 4. 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: 1. Erythema 2. Swelling or induration 3. Local warmth 4. Purulent drainage 5. Tenderness to palpation or pain 5. Pus or drainage from wound that can be sent for clinical culture 6. Able to take oral antibiotic therapy, either in pill or suspension form 7. 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: 8. 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. 9. 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. 10. 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. Exclusion Criteria: 1. Cellulitis without abscess, drainage, or other culturable exudate. 2. Hospital inpatient 3. Hospitalization within the prior 14 days 4. Residence in a long-term skilled nursing facility 5. Requirement for hospitalization for skin infection or other condition 6. Previous enrollment in this protocol 7. Participation in another clinical trial within the previous 30 days 8. Superficial skin infection only, including 1. Impetigo 2. Ecthyma 3. Folliculitis 4. Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures 9. Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements 10. 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 11. Systolic blood pressure > 180 mm Hg 12. Systolic blood pressure (SBP) less than an age-specific critical value: 1. Age 9 to 17 years: < 90 mm Hg 2. Age = 18 years: < 90 mm Hg 13. Heart rate less than 45 beats per minute (BPM) 14. Heart rate greater than an age-specific-critical value: 1. Age 9 to 17 years: > 120 BPM 2. Age = 18 years: > 120 BPM 15. Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) less than 35.5° C (95.9° F) 16. Oral temperature (or equivalent rectal, tympanic membrane, axillary defined in Table 2) greater than age-specific critical value: 1. Age 9 to 17 years: > 38.5° C (101.3° F) 2. Age = 18 years: > 38.5° C (101.3° F) 17. Documented human or witnessed animal bite in the past 30 days at the site of infection 18. Received prior systemic antibacterial therapy with anti-staphylococcal activity within the prior 14 days who do not meet inclusion criteria 8, 9 and 10. 19. 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 20. 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 21. Infection at an anatomical site skin requiring specialized management or specialized antimicrobial therapy, including 1. Periauricular or orbital infection 2. Perirectal infection 3. Suspected deep space infection of the hand or foot 4. Genital infection 5. Mastitis 6. Bursitis 22. 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) 23. Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics 24. Hypersensitivity or history of allergic reaction to study drug 25. History of G6PD deficiency 26. 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. 27. 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. 28. Complicated skin or soft tissue infection, such as 1. Catheter or catheter site infection within 30 days of placement 2. Surgical site infection 3. Known or suspected prosthetic device infection 4. Suspected Gram-negative or anaerobic pathogen 5. Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc) 29. History of drug-induced thrombocytopenia and documented megaloblastic anemia due to folate deficiency. 30. Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis 31. History of severe underlying immunocompromising condition or immunodeficiency, for example 1. Chronic renal failure, creatinine clearance <30 ml/min 2. Renal dialysis within the past 180 days 3. 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 4. Cancer or malignancy with receipt of systemic chemotherapy in the prior 180 days 5. Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease 6. Other serious underlying disease, as determined by the treating physician or the investigator |
Country | Name | City | State |
---|---|---|---|
United States | Washington University | Saint Louis | Missouri |
United States | Olive View-UCLA Medical Center | Sylmar | California |
United States | Harbor-UCLA Medical Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | National Institute of Allergy and Infectious Diseases (NIAID), University of California, Los Angeles, Washington University School of Medicine |
United States,
Adcock 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. — View Citation
Centers 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. — View Citation
Centers 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. — View Citation
Centers 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. — View Citation
Centers 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. — View Citation
Centers 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. — View Citation
Chambers HF. The changing epidemiology of Staphylococcus aureus? Emerg Infect Dis. 2001 Mar-Apr;7(2):178-82. doi: 10.3201/eid0702.010204. — View Citation
Ellis 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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Day 2-3 (48-72 hours) | |
Secondary | 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 | Day 7 | |
Secondary | 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 | Day 37 | |
Secondary | 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. | Day 0-365 | |
Secondary | 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. | Day 0-365 | |
Secondary | 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. | Day 37 | |
Secondary | 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. | Day 180 | |
Secondary | 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. | Day 365 |
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