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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06982105
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
2 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Trimethoprim Sulfamethoxazole — DRUG
    * 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

Study Details

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

Key Dates

Start date
May 20, 2025
Status verified
Jun 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TMP-SMX
    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
  • Active Comparator: Clindamycin
    13 mg/kg/dose PO every 8 hours (max 600mg/dose) Duration will be at the discretion of the treating provider

Primary Outcome Measure

Number of Participants with Treatment Success [ Time Frame: 6 months post hospitalization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Riley Hospital for ChildrenIndianapolisIndiana46202
James B Wood, MD
[email protected]

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By research site
Riley Hospital for Children· Indianapolis, IN

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