NCT06982105 Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
| NCT ID | NCT06982105 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Methicillin Resistant Staphylococcus Aureus |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-05-20 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility Criteria
Inclusion Criteria: 1. 60 days to 18 years of age (inclusive) at the time of oral step down treatment 2. 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 3. 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) 4. Currently ready or planned to be transitioned to oral antibiotic therapy by the clinical team 5. OAI or HNI symptoms \< 14 days at the time of hospital admission Exclusion Criteria: 1. Enrollment in another interventional study or receipt of investigational drug as part of a research trial within the past 30 days. 2. Known cancer, acquired or primary (including sickle cell anemia or G6PD deficiency) immunodeficiency 3. Underlying bone disease, presence of hardware /implantable device in affected bone/joint 4. Infection (OAI or HNI) resulting from penetrating wounds, open fractures, major trauma, foreign body or post-operative infection. 5. Spinal osteomyelitis 6. Underlying chronic renal, gastrointestinal, liver, or heart disease that would be expected to potentially affect absorption or the metabolism of assigned drug 7. Inability to take medicine by mouth, gastrostomy, jejunostomy or nasogastric tube 8. Received intravenous antibiotic therapy as the treatment for OAI or HNI \>14 days. 9. Inability or unwilling to consent 10. Any social or medical conditions judged by the study clinician to preclude participation because it could negatively affect the participant. 11. Allergy to both TMP-SMX and clindamycin 12. Known MRSA isolate resistant to both TMP-SMX and clindamycin 13. Patient is known to be pregnant at the time of enrollment
Contact & Investigator
James Wood, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06982105 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 18 Years, studying Methicillin Resistant Staphylococcus Aureus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06982105 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06982105 currently recruiting?
Yes, NCT06982105 is actively recruiting participants. Contact the research team at mestumpf@iu.edu for enrollment information.
Where is the NCT06982105 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06982105 clinical trial?
NCT06982105 is sponsored by Indiana University. The principal investigator is James Wood, MD at Indiana University. The trial plans to enroll 100 participants.