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

NCT06982105 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-04

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • James Wood, MD · Indiana University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-20
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06982105 on ClinicalTrials.gov