Trimethoprim-sulfamethoxazole versus clindamycin for children with invasive MRSA infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Children with invasive MRSA infections of bone, joints, or head and neck who are switching to oral therapy will receive either trimethoprim-sulfamethoxazole or clindamycin and be followed for treatment success and side effects. The study includes patients aged 60 days through 18 years and covers osteomyelitis, septic arthritis, orbital and facial cellulitis, and other related infections. Treatment duration and follow-up visits are determined by the treating clinical team, with safety monitoring for adverse reactions. The main outcomes are whether the oral antibiotic clears the infection and the frequency and severity of side effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Riley Hospital for Children
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: James Wood, MD — Indiana University
• Study coordinator: Mary Stumpf
• Email: mestumpf@iu.edu
• Phone: 317-274-8801

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Oral antibiotics for treating bone and joint infections in children

  This study is testing if giving oral antibiotics first can effectively and safely treat uncomplicated bone and joint infections in children and teens aged 3 months to 17 years.

  Recruiting Copenhagen University Hospital, Rigshospitalet · Copenhagen Ø · NCT06827496

• One-time IV penicillin added to standard penicillin for adults with acute tonsillitis, tonsillitis with peritonsillar phlegmon, or peritonsillar abscess

  A single dose of intravenous benzylpenicillin is given alongside standard oral penicillin to adults with acute tonsillitis, peritonsillar phlegmon, or peritonsillar abscess to see if symptoms improve.

  Recruiting Phase 4 Aarhus University Hospital · Aarhus, Central Jutland · NCT07896226

• Transoral ultrasound versus standard clinical exam to diagnose peritonsillar abscess

  This trial will test whether adding transoral ultrasound helps doctors tell which adults with suspected peritonsillar abscess need drainage.

  Recruiting at 2 sites Copenhagen University Hospital, Rigshospitalet · Copenhagen and 2 other locations · NCT07577232

• High-resolution infrared imaging to detect bone, joint and soft-tissue infections in children

  We will test whether a 10-second high-resolution infrared thermal video can help detect bone, joint, or soft-tissue infections in children up to 15 years old.

  Recruiting Sheffield Children's NHS Foundation Trust · Sheffield, South Yorkshire · NCT07388017

• Understanding complicated infections in ear, nose, and throat

  This study looks at how doctors treat complicated ear, nose, and throat infections to see if they can improve recovery times and outcomes for patients in Slovenia.

  Recruiting University Medical Centre Ljubljana · Ljubljana, Ljubljana · NCT06023550

• Oral antibiotics for treating bone and joint infections in children

  This study tests if giving only oral antibiotics can effectively treat bone and joint infections in children, compared to the usual method that starts with IV antibiotics.

  Recruiting at 9 sites Phase 4 Murdoch Childrens Research Institute · Kingswood, New South Wales and 10 other locations · NCT04538053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.