Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-18
SponsorIndiana University

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

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators