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Safety and effectiveness of add on drug pentoxifylline in patients suffering from community acquired pneumonia

Evaluation of efficacy and safety of adjuvant Pentoxifylline therapy in adults with community acquired pneumonia: An Open label, Randomized-controlled trial. - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072499
Enrollment
60
Registered
2024-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J189- Pneumonia, unspecified organism

Interventions

Intervention1: PENTOXIFYLLINE SUPPLEMENTATION ALONG WITH STANDARD TREATMENT: In the experimental group, pentoxifylline will be given in the dose of 400 mg twice daily enterally within 24 hours of rand

Sponsors

SARANDEV A T V
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)At least one acute clinical sign compatible with pneumonia (dyspnea, cough, purulent sputum, crackles) 2)Infiltrate on chest X-ray or CT scan suggestive of pneumonia 3)Diagnosis of CAP at or during the 48 hours post-hospital admission. 4)Informed consent signed by the patient, his/her legally authorized representative.

Exclusion criteria

Exclusion criteria: 1)Patient on invasive mechanical ventilation. 2)Patients with creatinine clearance less than 30 ml per minute 3)Patient on vasopressors at the time of inclusion 4)Any contraindications to the study drug 5)Patient requiring corticosteroids (except for nebulized corticosteroids) for any reason. 6)Patient treated with antibiotics for more than 7 days prior to admission. 7)Suspicion of aspiration or heath care associated pneumonia. 8)Active tuberculosis 9)On immunosuppressive therapy or malignancy 10)Pregnancy or lactating women

Design outcomes

Primary

MeasureTime frame
Time to overall clinical stability (TCS) defined as temperature less than or equall to 37·8 degree celsius, heart rate below 100 beats per minute, respiratory rate below 24 breaths per minute, arterial oxygen saturation of 90 percentage or higher on room air, systolic blood pressure of 90 mm Hg or higher, and baseline mental status. TCS is defined as the first day after the starting of study drug all the 5 vital signs fulfill the above criteria on same day and eating and mental status are stable. Timepoint: Over 7 days

Secondary

MeasureTime frame
To evaluate the change in inflammatory markers in terms of change in serum CRP and TNF alpha level between the groups. To evaluate the length of hospital stay (LOS) between the groups. To evaluate the time to individual vital sign stability between the groups. To determine the adverse effects in both the groups.Timepoint: Over the period of study

Countries

India

Contacts

Public ContactDR DHRITI SUNDAR DAS

AIIMS BHUBANESWAR

genmed_dhriti@aiimsbhubaneswar.edu.in8011605711

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026