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NCT Number: NCT06265389

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

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Key information

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tanta University

Tanta, Gharbia Governorate, 37515, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentoxifylline Oral Tablet

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.

Other names: TRENtal

Primary outcomes

  1. Respiratory distress

    Time frame: 3 days

    Duration of improvement of respiratory distress

  2. Temperature

    Time frame: 3 days

    Duration of defeverness

  3. Oxygen saturation

    Time frame: 3 days

    Duration of normalization of hypoxia

  4. CRP

    Time frame: 5 days

    Duration of normalization of CRP

  5. LDH

    Time frame: 5 days

    Duration of normalization of LDH

  6. D-dimer

    Time frame: 5 days

    Duration of normalization of D-dimer

  7. Interleukin 6

    Time frame: 5 days

    Duration of normalization of IL-6

Secondary outcomes

  1. Hospital stays

    Time frame: 14 days

    Duration of stay in hospital

  2. Pneumonia complications

    Time frame: 14 days

    Occurrence of pneumonia complications

Other outcomes

  1. Surgical intervention

    Time frame: 14 days

    Intercostal chest tube, bronchoscope, decortication, lobectomy

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.