Actively Recruiting

Phase 4
Age: 2Months - 18Years
All Genders
NCT06982105

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

Led by Indiana University · Updated on 2025-06-04

100

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 60 days and 18 years at the time of oral step-down treatment
  • Diagnosed with osteoarticular infection (OAI) or head and neck infection (HNI) confirmed by clinical signs or radiographic evidence
  • Treated by the clinical team for confirmed or suspected MRSA infection
  • Ready or planned to transition to oral antibiotic therapy
  • Symptoms of OAI or HNI less than 14 days at hospital admission
Not Eligible

You will not qualify if you...

  • Enrollment in another interventional study or receipt of investigational drug within past 30 days
  • Known cancer, immunodeficiency, sickle cell anemia, or G6PD deficiency
  • Underlying bone disease or presence of hardware/implant in affected area
  • Infection caused by penetrating wounds, open fractures, major trauma, foreign body, or post-operative infection
  • Spinal osteomyelitis
  • Chronic renal, gastrointestinal, liver, or heart disease affecting drug absorption or metabolism
  • Inability to take medicine by mouth or via feeding tubes
  • More than 14 days of intravenous antibiotic treatment for OAI or HNI
  • Inability or unwillingness to consent
  • Social or medical conditions that could negatively affect participation
  • Allergy to both TMP-SMX and clindamycin
  • Known MRSA resistant to both TMP-SMX and clindamycin
  • Known pregnancy at enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Riley Hospital for Children

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

M

Mary Stumpf

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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