Skin- and soft-tissue Infection (SSTI) Infections and Infestations Skin- and soft-tissue Infection (SSTI)
Conditions
Interventions
The planned intervention is the switch from intravenous to oral antibiotic treatment after 48 hours, provided that clinical criteria according to a predefined checklist are fulfilled (designated as in
Sponsors
University of Bern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult (= 18 years old) with SSTI 2. Ability to understand and sign patient consent form 3. Ability to consent for data use, or to consent for oral treatment, or to consent for both 4. Not fulfilling exclusion criteria
Exclusion criteria
Exclusion criteria: 1. Received antibiotics 14 days or less prior to study inclusion 2. Necrotizing fasciitis 3. Septic shock or infection requiring intensive medicine care 4. Impetigo without erysipelas or cellulitis 5. Arthritis, Osteomyelitis, Tenosynovitis, Prosthetic Joint Infection, Foreign Body Infection 6. Mastitis 7. Non-bacterial infection or sterile skin inflammation 8. Surgical site infections 9. Skin abscess, bursitis, 10. Diabetic Foot Infection PEDIS classification 3 11. Bacteraemia with Staphylococcus aureus or Pseudomonas aeruginosa 12. Ecthyma gangraenosum 13. Gram-negative bacteria as causing organism for SSTI 14. Pregnant and lactating women can be included ONLY in the observation arm, and NOT in the intervention arm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number cured cases measured as ‘total number of treated cases’ minus ‘the number of failed cases’. Clinical failure is defined as increase in symptoms during antibiotic treatment or new course of antibiotics between end of therapy and 2 weeks after end of treatment or death or readmission for skin and soft tissue infection within 30 days of discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of intravenous treatment measured in number of doses and days of treatment assessed by reviewing patient notes. 2. The following baseline factors and parameters will be assessed at baseline and during treatment, respectively: 2.1 Host variables: Age, sex, body mass index, allergies, comorbidities (cardiovascular), renal function, diabetes mellitus, insulin dependent, immunosuppression, cancer, alcohol consumption, IVDU.* 2.2 Clinical sepsis variables: pain at the site of infection, the presence of chills, body temperature, blood pressure (diastolic and systolic), heart frequency, O2-Saturation with or without oxygen.* 2.3 Referral dynamic variables: time from onset of symptoms to first physician contact, time from first physician contact to referral.* 2.4 SSTI variables: site of infection, size, color, portal of entrance, blisters* 2.5 Laboratory values (only if available and obtained at the discretion of the treating team): Hemoglobin, leukocytes, thrombocytes, creatinine, urea, ASAT, ALAT, bilirubin, alkaline phosphatase.^ 2.6 Bacterial variables: Microorganism, minimal inhibitory concentration of antimicrobial compounds.* 2.7 Antibiotic variables: compound, dose, dosing scheme, application form, duration of treatment.* *Assessed by reviewing patient notes. ^Laboratory investigations are ordered at the discretion of the treating physician. However, laboratory results will be obtained for the study, alongside to the closest date of clinical data. 3. Clinical recovery assessed by a short telephone interview at day 30. | — |
Countries
Switzerland
Outcome results
None listed