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临床试验/NCT06265389
NCT06265389已完成4 期

Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
D-dimer

研究概览

简要总结

Pentoxifylline is a xanthine-derived, commercially produced drug approved for the management of intermittent claudication in patients suffering from a chronic occlusive arterial disease of the limbs. Pentoxifylline has been documented to display anti-inflammatory and immunomodulatory effects, as well as some antithrombotic and antiviral effects. This drug has also been shown to reduce lung fibrosis in patients with COVID-19, as well as to prevent thromboembolic events. This work aims to assess the benefit of oral Pentoxifyllin supplementation, in addition to standard antibiotic and other supportive therapy, in the management of hospitalized children with community-acquired pneumonia

详细描述

This is a randomized clinical trial study that will be carried out on 100 children with Community-acquired pneumonia admitted to the Pulmonology Unit, Pediatric department.

Group 1: Pentoxifylline group, and group 2: Control group

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
2 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All children aged 2 months -18 years with community-acquired pneumonia diagnosed by signs and symptoms of CAP including; chest pain, dyspnea, tachypnea, or abnormal auscultatory findings plus focal findings on chest x-ray indicating community-acquired pneumonia

排除标准

  • Children with immunodeficiency, chronic lung disease, malignancy, congenital lung anomalies, underlying disorders impacting respiration i.e. genetic, metabolic, neuromuscular disorders, and children with CHD affecting the pulmonary blood flow.

研究组 & 干预措施

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form

Experimental

50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form at a dose of 20 mg/kg/day, as an adjunct therapy to the usual pneumonia treatment for 5 days

干预措施: Pentoxifylline Oral Tablet (Drug)

结局指标

主要结局

D-dimer

时间窗: 5 days

Duration of normalization of D-dimer

Interleukin 6

时间窗: 5 days

Duration of normalization of IL-6

Oxygen saturation

时间窗: 3 days

Duration of normalization of hypoxia

Respiratory distress

时间窗: 3 days

Duration of improvement of respiratory distress

CRP

时间窗: 5 days

Duration of normalization of CRP

LDH

时间窗: 5 days

Duration of normalization of LDH

Temperature

时间窗: 3 days

Duration of defeverness

次要结局

  • Hospital stays(14 days)
  • Pneumonia complications(14 days)

研究者

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

Rehab Zaki Elmeazawy

Doctor

Tanta University

研究点 (1)

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