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

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

Study Overview

• Status: Completed
• Conditions: Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia
• Intervention / Treatment: Drug: Pentoxifylline Oral Tablet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 37515
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form; 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	Drug: Pentoxifylline Oral Tablet; 50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form as an adjunct therapy to the usual pneumonia treatment for 5 days and the control group includes 50 children with community-acquired pneumonia with the standard pneumonia treatment.; Other Names: TRENtal
No Intervention: 50 children with community-acquired pneumonia with the standard pneumonia treatment.; 50 children with community-acquired pneumonia with the standard pneumonia treatment as a control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature	Duration of defeverness	3 days
Respiratory distress	Duration of improvement of respiratory distress	3 days
Oxygen saturation	Duration of normalization of hypoxia	3 days
CRP	Duration of normalization of CRP	5 days
LDH	Duration of normalization of LDH	5 days
D-dimer	Duration of normalization of D-dimer	5 days
Interleukin 6	Duration of normalization of IL-6	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital stays	Duration of stay in hospital	14 days
Pneumonia complications	Occurrence of pneumonia complications	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical intervention	Intercostal chest tube, bronchoscope, decortication, lobectomy	14 days

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: February 11, 2024
• First Submitted That Met QC Criteria: February 11, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 9, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antioxidants; Protective Agents; Free Radical Scavengers; Vasodilator Agents; Phosphodiesterase Inhibitors; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: Pentoxifylline in pneumonia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No