Actively Recruiting
Comparing Trimethoprim-Sulfamethoxazole and Clindamycin for Treating Children with Invasive MRSA Infections
Led by Indiana University · Updated on 2025-06-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well trimethoprim-sulfamethoxazole (TMP-SMX) works compared to clindamycin in treating invasive infections caused by methicillin-resistant Staphylococcus aureus (MRSA) in children. The study also aims to understand the safety of TMP-SMX when used for these infections. This is a Phase 4 clinical trial involving children with confirmed or suspected MRSA infections affecting bones, joints, or head and neck areas. Participants will be randomly assigned to receive either TMP-SMX or clindamycin as oral antibiotic therapy. The dosing for TMP-SMX varies depending on the infection type: 4-5 mg/kg every 8 hours for osteoarticular infections or 5-6 mg/kg every 12 hours for head and neck infections, with maximum doses specified. Clindamycin is given at 13 mg/kg every 8 hours. Treatment duration is determined by the healthcare provider. The study compares these two treatments to see which works better or if they are similar. During the trial, children will take the assigned antibiotic and keep a diary to track symptoms and any side effects. Follow-up visits will occur as decided by their healthcare provider. Researchers will measure treatment success six weeks and six months after hospitalization and monitor any antibiotic-related side effects. Participation lasts through these follow-up periods to ensure careful assessment of outcomes and safety.
CONDITIONS
Brief Title
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 60 days and 18 years at the time of oral antibiotic treatment
- Diagnosed with osteoarticular infection (OAI) or head and neck infection (HNI) confirmed by clinical findings or imaging
- Confirmed or suspected MRSA infection treated by the clinical team
- Ready or planned to start oral antibiotic therapy
- Symptoms of OAI or HNI less than 14 days at hospital admission
You will not qualify if you...
- Enrolled in another interventional study or received investigational drug in past 30 days
- Known cancer or immunodeficiency including sickle cell anemia or G6PD deficiency
- Underlying bone disease or implantable device in affected bone or joint
- Infection resulting from penetrating wounds, fractures, trauma, foreign body, or post-operative infection
- Spinal osteomyelitis
- Chronic renal, gastrointestinal, liver, or heart disease affecting drug absorption or metabolism
- Unable to take medicine by mouth or feeding tube
- Received intravenous antibiotics for OAI or HNI for more than 14 days
- Unable or unwilling to consent
- Social or medical conditions that may 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At the discretion of the treating provider
Participants receive oral antibiotic treatment with either trimethoprim-sulfamethoxazole or clindamycin as prescribed by their provider.
Visits as scheduled by the clinical team during treatment
Duration - Up to 6 months post hospitalization
Participants are monitored for treatment success and antibiotic-related adverse events after completing treatment.
Follow-up visits at 6 weeks and 6 months post hospitalization
Trial Site Locations
Total: 1 location
1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
M
Mary Stumpf
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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