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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Months - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06982105
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Indiana University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

James Wood, MD
Principal Investigator Affiliation Indiana University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute, Septic Arthritis, Orbital Cellulitis, Facial Cellulitis, Mastoiditis, Cervical Adenitis, Retropharyngeal Abscess, Peritonsillar Abscess
Arms & Interventions

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

Interventions

Drug: - 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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Riley Hospital for Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital for Children

Indianapolis, Indiana, 46202

Site Contact

James B Wood, MD

[email protected]

317-274-8801