NCT06982105

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

Comparing Optimal Step-down Therapy for Children With Invasive MRSA Trimethoprim-Sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Methicillin Resistant Staphylococcus Aureus
• Osteomyelitis Acute
• Septic Arthritis
• Orbital Cellulitis
• Facial Cellulitis
• Mastoiditis
• Cervical Adenitis
• Retropharyngeal Abscess
• Peritonsillar Abscess

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-05-21
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study