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

Phase 2
Conditions
Health Condition 1: J189- Pneumonia, unspecified organism
Registration Number
CTRI/2024/08/072499
Lead Sponsor
SARANDEV A T V
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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. <br/ ><br> <br/ ><br>Timepoint: Over 7 days
Secondary Outcome Measures
NameTimeMethod
To evaluate the change in inflammatory markers in terms of change in serum CRP and TNF alpha level between the groups. <br/ ><br>To evaluate the length of hospital stay (LOS) between the groups. <br/ ><br>To evaluate the time to individual vital sign stability between the groups. <br/ ><br>To determine the adverse effects in both the groups.Timepoint: Over the period of study
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