Status:
RECRUITING
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Lead Sponsor:
Indiana University
Conditions:
Methicillin Resistant Staphylococcus Aureus
Osteomyelitis Acute
Eligibility:
All Genders
2-18 years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 60 days to 18 years of age (inclusive) at the time of oral step down treatment
- Diagnosed by the clinical team with OAI or HNI:
- OAI- at least 1 focal finding and 1 systemic finding OR radiographic confirmation of OAI
- Focal finding- pain/swelling over a bone/joint, or restricted movement/failure to bear weight
- Systemic finding- fever \>38oC, or elevated c-reactive protein (CRP) or elevated erythrocyte sedimentation rate. (ESR) or elevated white blood cell count (WBC) or elevated WBC in synovial fluid OR
- Radiographic confirmation- findings consistent with osteomyelitis or septic arthritis - Plain radiograph, MRI, CT or ultrasound, bone scan result indicating abnormal bone, subperiosteal or bone marrow findings consistent with infection
- HNI- at least 1 focal finding and 1 systemic finding OR radiographic confirmation of HNI
- Focal finding- facial pain or redness, eye pain or proptosis, neck or throat pain or swelling, ear pain or proptosis
- Systemic finding- fever \>38oC, or elevated CRP or elevated ESR or elevated WBC OR
- Radiographic confirmation- findings consistent with facial/orbital cellulitis, cervical lymphadenitis, mastoiditis, or deep neck infection/abscess (including peritonsillar, retro- and para-pharyngeal. Plain radiograph, MRI, CT or ultrasound, bone scan result indicating abnormal findings consistent with infection
- Treated by the clinical team for confirmed MRSA or suspected MRSA infection
- Confirmed MRSA- positive culture for MRSA from a sterile body fluid (e.g., blood, abscess, bone, synovial fluid, or other surgical specimen)
- Suspected MRSA- treatment for MRSA by the clinical team without microbiologic confirmation (e.g., negative cultures)
- Currently ready or planned to be transitioned to oral antibiotic therapy by the clinical team
- OAI or HNI symptoms \< 14 days at the time of hospital admission
Exclusion
- Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days.
- Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency
- Underlying bone disease, presence of hardware /implantable device in affected bone/joint
- Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection.
- Spinal osteomyelitis
- Underlying chronic renal, gastrointestinal, liver, or heart disease that would be expected to potentially affect absorption or the metabolism of assigned drug
- Inability to take medicine by mouth, gastrostomy, jejunostomy or nasogastric tube
- Received intravenous antibiotic therapy as the treatment for OAI or HNI \>14 days.
- Inability or unwilling to consent
- Any social or medical conditions judged by the study clinician to preclude participation because it could negatively affect the participant.
- Allergy to both TMP-SMX and clindamycin
- Known MRSA isolate resistant to both TMP-SMX and clindamycin
- Patient is known to be pregnant at the time of enrollment
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06982105
Start Date
May 20 2025
End Date
June 1 2027
Last Update
June 4 2025
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202