Assessment of antibiotic utilization in diabetic patients with infection: a prospective longitudinal study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- ADRs, drug interactions, appropriateness of antibiotic treatment and need for deescalation of antibiotic therapy
Study Overview
Brief Summary
A Prospective study will be conducted at the Department of Infectious Diseases that will include minimum of 366 patients with culture positive infections and diabetes. Literature review will be conducted followed by development of Case Report Form to collect relevant clinical data of the patients. The appropriateness of the prescriptions of antibiotics will be assessed and will also look for ADRs and conduct Causality and Severity assessment. Drug-Drug interactions will be identified. There will be base line data collection and follow up. Need of de-escalation of antibiotic administration will be evaluated as per guidelines.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of both genders and above 18 years of age with known case of diabetes with presence of culture positive bacterial infections are included.
Exclusion Criteria
- •Lactating or pregnant patients are excluded.
- •Terminally ill and psychiatric patients are excluded.
Outcomes
Primary Outcomes
ADRs, drug interactions, appropriateness of antibiotic treatment and need for deescalation of antibiotic therapy
Time Frame: At baseline and everyday until the date of discharge
Secondary Outcomes
No secondary outcomes reported
Investigators
Lloyd Blannie Barnes
Manipal Academy Of Higher Education