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临床试验/NCT05219877
NCT05219877已完成1 期

Comparison of the Effectiveness of Preurodynamic Single Dose of Levofloxacin With Posturodynamic Levofloxacin for Three Days on the Incidence of Urinary Tract Infections

Indonesia University1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2022年2月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
134
试验地点
1
主要终点
Number of Participant With Urinary Tract Infection

研究概览

简要总结

This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.

详细描述

This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination. This study uses a randomized single-blind trial design to compare the proportion of posturodynamic UTI in the group receiving preurodynamic single-dose levofloxacin with the group receiving three days - once daily of Levofloxacin posturodynamic. The target population is patients who undergo urodynamic examination at the RSUPN dr. Cipto Mangunkusumo, Siloam ASRI Hospital, and Persahabatan Hospital during the given time.

of the study. The total sample size in this study was determined based on a two-proportion analytical sample calculation formula with type 1 error of 5% and type 2 error of 80%. On the fourth posturodynamic day, urinalysis and urine culture were performed to determine the diagnosis of UTI. To analyze the association between UTI and the treatment group, the chi-square test was used. Results were considered statistically significant if p < 0.05.

The expected results are data on the comparison of the incidence of UTI after urodynamic examination in the group given a single dose of levofloxacin and levofloxacin for three days post-examination.

The incidence of UTI in the group receiving a single preurodynamic dose of levofloxacin compared to the group receiving levofloxacin for three days posturodynamics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

This study uses a single-blinded design because the outcome assessed in this study is urinalysis which is the objective outcome. The urinalysis evaluator is blinded to the drug regimen obtained by the research subjects.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male/female patients > 18 years who have indications for urodynamics
  • Willing to participate in research

排除标准

  • Allergy to levofloxacin
  • History of taking antibiotics in 1 month • Pregnant
  • Uncontrolled DM
  • Use a urinary catheter
  • Having a UTI before urodynamics, based on clinical symptoms and urine examination results
  • Refuse to participate in research

研究组 & 干预措施

Pre-urodynamic Levofloxacin

Experimental

Levofloxacin 500 mg single dosage 1 hour before the urodynamic examination

干预措施: Pre-urodynamic Levofloxacin (Drug)

Post-urodynamic Levofloxacin

Active Comparator

Levofloxacin 500 mg will be given for 3 days, once daily, post-urodynamic examination

干预措施: Post-urodynamic Levofloxacin (Drug)

结局指标

主要结局

Number of Participant With Urinary Tract Infection

时间窗: 4 days after urodynamic

Urinary tract infection is defined based on the result of urinalysis in which one of the following condition present : leukocyes \> 5 / high power field, bacteria positive, nitrite positive, and/or positive leukocyte esterase

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

dr. Harrina Erlianti Rahadjo, Sp.U(K), PhD

Prof. dr., Sp.U(K), PhD

Indonesia University

研究点 (1)

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