Trial intelligence / Profile preview

Ciprofloxacin vs Levofloxacin on QTc and Dysglycemia

NCT04456712Phase 4

Key facts

Status: Completed
Start: Jun 2018
Primary completion: Nov 2018
Countries: 1
Sponsor: Beni Suef University
Modality: Small Molecules

Drugs: ciprofloxacinlevofloxacin
Conditions: bacterial infection

Overview

Phase 4, randomised, open-label trial of ciprofloxacin and levofloxacin in bacterial infection (4 arms), sponsored by Beni Suef University. Primary endpoints: Corrected QT interval and Fasting blood glucose. Started Jun 2018; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Ciprofloxacin (Diabetic)
Ciprofloxacin 400mg IV q12h
Levofloxacin (Diabetic)
Levofloxacin 750mg IV q24h
Ciprofloxacin (Non-Diabetic)
Ciprofloxacin 400mg IV q12h
Levofloxacin (Non-Diabetic)
Levofloxacin 750mg IV q24h

Who it enrols

Adult patients (18-70 years) with or without diabetes, excluding those with prolonged QTc, heart disease history, or use of interacting drugs.

Endpoints

Primary

Corrected QT interval72 hours post-cessation
Fasting blood glucose72 hours post-cessation

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