What side effects are associated with this type of intervention?

Common treatments for Skin and Soft Tissue Infections (SSTIs) include antibiotics such as beta-lactams, clindamycin, and doxycycline. Beta-lactams can cause side effects like gastrointestinal upset, allergic reactions, and, rarely, hematologic abnormalities. Clindamycin is associated with gastrointestinal disturbances, including diarrhea and a risk of Clostridioides difficile infection. Doxycycline can cause photosensitivity, gastrointestinal upset, and esophageal irritation. These side effects should be considered when selecting an appropriate antibiotic regimen.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Skin and Soft Tissue Infections (SSTIs) include several antibiotics designed to combat resistant pathogens. Notable examples include linezolid (Zyvox), which is effective against methicillin-resistant Staphylococcus aureus (MRSA), and daptomycin (Cubicin), which is used for complicated SSTIs caused by Gram-positive bacteria. Additionally, ceftaroline (Teflaro) has been approved for its efficacy against MRSA and other resistant strains. These drugs align with the precision medicine approach studied in the INSPIRE trial, which aims to optimize antibiotic use based on the likelihood of resistant infections.

What other types of research exist?

Promising alternatives to CPOE Smart Prompts for SSTI patients include algorithm-based smartphone apps for risk assessment, smart device-based applications for serial wound imaging and management, and advanced remote monitoring systems like the Confirm Rx™ insertable cardiac monitor with SharpSense™ technology. These technologies offer real-time data collection, improved diagnostic accuracy, and remote monitoring capabilities, which can enhance infection management and treatment outcomes.

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INSPIRE Stewardship Bundle for Skin and Soft Tissue Infections

N/A

Waitlist Available

Led By Susan Huang, MD, MPH

Research Sponsored by Harvard Pilgrim Health Care

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a computer system that helps doctors choose the right antibiotics for adults with skin infections by predicting if the infection will resist common treatments.

Who is the study for?

The INSPIRE trial is for HCA Healthcare hospitals using MEDITECH electronic health records, admitting non-critically ill adults with skin and soft tissue infections. It's not about individual patients but the hospital practices.

What is being tested?

This study compares routine care against a new 'Stewardship Bundle' that uses smart software prompts to guide antibiotic use, aiming to improve treatment by predicting resistant infections in real-time.

What are the potential side effects?

Since this trial focuses on hospital procedures rather than direct patient interventions, it doesn't involve typical medication side effects. However, changes in practice could impact patient recovery times and infection management.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Empiric Extended-Spectrum Antibacterial Days of Therapy (Empiric ES-DOT)

Secondary study objectives

Antipseudomonal Antibiotic Days of Therapy per Empiric Day

Other study objectives

Empiric and Total Antibiotic Costs

Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period

Incidence of Hospital-Onset C. difficile

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Arm 2: INSPIRE Stewardship BundleActive Control1 Intervention

Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for skin/soft tissue infection in the first 3 days of hospitalization.

Group II: Arm 1: Routine CareActive Control1 Intervention

Continuation of routine antibiotic stewardship strategies.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Skin and Soft Tissue Infections (SSTIs) are antibiotics, which work by targeting and killing bacteria or inhibiting their growth. Beta-lactams (e.g., penicillins, cephalosporins) disrupt bacterial cell wall synthesis, leading to cell lysis. Macrolides (e.g., erythromycin) inhibit protein synthesis by binding to bacterial ribosomes. Tetracyclines (e.g., doxycycline) also inhibit protein synthesis but by preventing the attachment of aminoacyl-tRNA to the ribosome. For resistant pathogens, such as MRSA, antibiotics like vancomycin (which inhibits cell wall synthesis) and linezolid (which inhibits protein synthesis) are used. Understanding these mechanisms is crucial for SSTI patients because it helps in selecting the most effective antibiotic, especially in the context of antibiotic resistance, ensuring better treatment outcomes and reducing the risk of complications.

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