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

NCT ID: NCT06265389

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-06-01

Brief Summary

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

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

Conditions

Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Pentoxifylline Oral Tablet

Intervention Type: DRUG

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

TRENtal

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Rehab Zaki Elmeazawy

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, Gharbia Governorate, Egypt

Countries

Egypt

Other Identifiers

Pentoxifylline in pneumonia

Identifier Type: -

Identifier Source: org_study_id