The goal of this clinical trial is to learn if trimethoprim-sulfamethoxazole (TMP-SMX) works to treat invasive infections due to methicillin-resistant Staphylococcus aureus (MRSA) in children. It will also learn about the safety of TMP-SMX in the treatment of children with invasive MRSA infections. The main questions it aims to answer are:
-Is TMP-SMX effective at successfully treating children with invasive infections due to MRSA? What are the side effects of TMP-SMX in children taking it for invasive infections due to MRSA?
Researchers will compare TMP-SMX to a clindamycin (a commonly prescribed antibiotic for the treatment of MRSA in children) to see if TMP-SMX works better, worse or the same as clindamycin for children with invasive infections due to MRSA.
Participants will:
Take TMP-SMX or clindamycin for the treatment of their invasive infection due to MRSA.
Will follow up with the provider treating their invasive infection at the discretion of the treating provider.
Keep a diary of their symptoms and any side effects of the medicine
60 days to 18 years of age (inclusive) at the time of oral step down treatment
OAI- at least 1 focal finding and 1 systemic finding OR radiographic confirmation of OAI
Focal finding- pain/swelling over a bone/joint, or restricted movement/failure to bear weight
Systemic finding- fever >38oC, or elevated c-reactive protein (CRP) or elevated erythrocyte sedimentation rate. (ESR) or elevated white blood cell count (WBC) or elevated WBC in synovial fluid OR
Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days.
Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency
Underlying bone disease, presence of hardware /implantable device in affected bone/joint
Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection.
Parallel
Trimethoprim Sulfamethoxazole
Drug* For osteoarticular infections- 4-5 mg/kg/dose (based on TMP) PO every 8 hours (max dose 320mg/dose) * For head and neck infections- 5-6 mg/kg/dose (based on TMP PO every 12 hours (max dose 320mg/dose) Duration will be at the discretion of the treating provider
Number of Participants with Treatment Success
Compare number of participants with treatment success vs. failure at 6 months post hospitalization
Number of Participants with Treatment Success at 6 weeks post-hospitalization
Compare number of participants with treatment success vs. failure at 6 weeks
Number of Participants who experience an antibiotic-related adverse events (AEs)
Compare number and severity of AEs between groups graded based on common terminology criteria for adverse events v5.0
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