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Clinical Trials/NCT07361185
NCT07361185
Terminated
Not Applicable

A Sticker Reminder Intervention to Promote Intravenous-to-Oral Fluoroquinolone Switching: A Cluster-Randomized Controlled Trial

Mahidol University0 sites168 target enrollmentStarted: July 1, 2020Last updated:

Overview

Phase
Not Applicable
Status
Terminated
Enrollment
168

Overview

Brief Summary

A single-center, cluster-randomized controlled trial was conducted to determine the effect of Sticker reminder intervention on IV-to-PO switching of fluoquinolone.

Detailed Description

A single-center, cluster-randomized controlled trial was conducted across 44 general wards at Siriraj Hospital, Thailand, from July 2020 to December 2024. The study population consisted of adult patients who received at least one dose of intravenous fluoroquinolones. Wards were randomized in a 1:1 ratio to either the sticker reminder intervention or standard care. In the intervention group, a reminder sticker was applied to patients' vital signs sheets when predefined IV-to-oral switching criteria were met. The primary outcome was the proportion of intravenous-to-oral fluoroquinolone switching in the intention-to-treat (ITT) and modified intention-to-treat (mITT) populations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients (aged ≥ 18 years)
  • Diagnosis of any infection
  • Receiving at least one dose of intravenous fluoroquinolones (ciprofloxacin, levofloxacin, or moxifloxacin)

Exclusion Criteria

  • Inability to tolerate oral medications (e.g., due to severe nausea/vomiting, malabsorption, active gastrointestinal bleeding, or severe diarrhea);
  • Being in an immunodeficiency state (e.g., neutropenia \[absolute neutrophil count ≤ 500 cells/mm3\], symptomatic HIV/AIDS, history of bone marrow or organ transplantation, leukemia, or current use of immunosuppressive agents); or
  • Having severe infections requiring exclusive intravenous antimicrobial therapy (e.g., infective endocarditis, meningitis, encephalitis, brain abscess, or prosthetic device infections).

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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