Pentoxifylline as an Adjunct Therapy in the Treatment of PneumoniaPhase 4NCT06265389
Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug
A Phase 4 study testing Pentoxifylline Oral Tablet in people with Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia
- What is being tested?
- Pentoxifylline Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Jun 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Being tested
- Pentoxifylline Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentoxifylline Oral TabletDrug
Also called TRENtal
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Pentoxifylline Oral Tablet |
| 50 children with community-acquired pneumonia with the standard pneumonia treatment. | No intervention | 50 children with community-acquired pneumonia with the standard pneumonia treatment as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory distress
Duration of improvement of respiratory distress
Measured: 3 days
Temperature
Duration of defeverness
Measured: 3 days
Oxygen saturation
Duration of normalization of hypoxia
Measured: 3 days
CRP
Duration of normalization of CRP
Measured: 5 days
LDH
Duration of normalization of LDH
Measured: 5 days
D-dimer
Duration of normalization of D-dimer
Measured: 5 days
Interleukin 6
Duration of normalization of IL-6
Measured: 5 days
Secondary outcomes (2)
Hospital stays
Duration of stay in hospital
Measured: 14 days
Pneumonia complications
Occurrence of pneumonia complications
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Mar 2024
- Primary completion31 Aug 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pentoxifylline as an Adjunct Therapy in the Treatment of PneumoniaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Zaki Elmeazawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265389
- Sponsor's protocol ID
- Pentoxifylline in pneumonia
- Status last verified
- Jun 2025
- First submitted
- 11 Feb 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elmeazawy R, AbdElsamea MZ, Barakat A, El Sharaby R, El-Moazen AMF, Hamza M, Toema O. Oral pentoxifylline as a novel adjunct to standard therapy in pediatric community-acquired pneumonia: a randomized controlled trial. Pediatr Res. 2026 May 5. doi: 10.1038/s41390-026-04997-3. Online ahead of print.
PubMed 42086944
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline as an Adjuvant Therapy in the Treatment of Pediatric Pneumonia; A New Perspective of an Old Drug
- ClinicalTrials.gov ID
- NCT06265389
- Acronym / sponsor ID
- Pentoxifylline in pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form | Experimental | Drug: Pentoxifylline Oral Tablet50 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 |
| 50 children with community-acquired pneumonia with the standard pneumonia treatment. | No intervention | –50 children with community-acquired pneumonia with the standard pneumonia treatment as a control group |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentoxifylline Oral TabletAlso: TRENtal50 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. | Drug | 50 children with community-acquired pneumonia will receive oral pentoxifylline in tablet form |
Primary outcome
Respiratory distress
Time frame: 3 days
Duration of improvement of respiratory distress
Temperature
Time frame: 3 days
Duration of defeverness
Oxygen saturation
Time frame: 3 days
Duration of normalization of hypoxia
CRP
Time frame: 5 days
Duration of normalization of CRP
LDH
Time frame: 5 days
Duration of normalization of LDH
D-dimer
Time frame: 5 days
Duration of normalization of D-dimer
Interleukin 6
Time frame: 5 days
Duration of normalization of IL-6
2 secondary outcomes
Hospital stays
Time frame: 14 days
Pneumonia complications
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Derived from this study: PubMed 42086944Elmeazawy R, AbdElsamea MZ, Barakat A, El Sharaby R, El-Moazen AMF, Hamza M, Toema O. Oral pentoxifylline as a novel adjunct to standard therapy in pediatric community-acquired pneumonia: a randomized controlled trial. Pediatr Res. 2026 May 5. doi: 10.1038/s41390-026-04997-3. Online ahead of print.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pentoxifylline Oral Tablet in people with Pentoxifylline as an Adjunct Therapy in the Treatment of Pneumonia, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory distress (time frame: 3 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.