Trimethoprim-Sulfamethoxazole for MRSA Infections

Overseen By Mary Stumpf

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Indiana University

Disqualifiers: Cancer, Immunodeficiency, Bone disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Duration will be at the discretion of the treating provider

100 Participants Needed

Trial Summary

What is the purpose of 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

Research Team

James Wood, MD

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

This trial is for children with invasive MRSA infections, showing symptoms like pain/swelling over a bone/joint or fever >38°C. They must have lab results indicating infection (like high CRP or WBC) or imaging confirming conditions such as osteomyelitis or cellulitis. Children already being treated for confirmed/suspected MRSA can join.

Inclusion Criteria

I have been diagnosed with osteoarthritis or hip necrosis.

I have been treated for a MRSA infection.

My symptoms started less than 14 days before I was admitted to the hospital.

Exclusion Criteria

I have received IV antibiotics for an infection for more than 14 days.

My MRSA infection is resistant to common antibiotics.

I have an infection in my spine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take TMP-SMX or clindamycin for the treatment of their invasive infection due to MRSA

Duration will be at the discretion of the treating provider

Follow up with the provider at the discretion of the treating provider

Follow-up

Participants are monitored for treatment success and adverse events

6 months

Regular follow-ups as per provider's discretion

Treatment Details

Interventions

• Trimethoprim-sulfamethoxazole

Trial Overview The study tests if trimethoprim-sulfamethoxazole (TMP-SMX) is effective and safe compared to clindamycin in treating children's invasive MRSA infections. Participants will take either TMP-SMX or clindamycin, monitor their symptoms, and report side effects in a diary.

Participant Groups

Group I: TMP-SMX Experimental Treatment 1 Intervention

Trimethoprim-sulfamethoxazole * 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

Group II: Clindamycin Active Control 1 Intervention

13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+