About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Trimethoprim Sulfamethoxazole