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CTRI Number  CTRI/2024/08/072499 [Registered on: 14/08/2024] Trial Registered Prospectively
Last Modified On: 09/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety and effectiveness of add on drug pentoxifylline in patients suffering from community acquired pneumonia 
Scientific Title of Study   Evaluation of efficacy and safety of adjuvant Pentoxifylline therapy in adults with community acquired pneumonia: An Open label, Randomized-controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DHRITI SUNDAR DAS 
Designation  ASSOCIATE PROFESSOR, DEPT OF GENERAL MEDICINE 
Affiliation  AIIMS BHUBANESWAR 
Address  ROOM NO 339,3rd FLOOR,DEPT OF GENERAL MEDICINE, ACADEMIC BLOCK,AIIMS BHUBANESWAR, BHUBANESWAR

Khordha
ORISSA
751019
India 
Phone  8011605711  
Fax    
Email  genmed_dhriti@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DR DHRITI SUNDAR DAS 
Designation  ASSOCIATE PROFESSOR, DEPT OF GENERAL MEDICINE 
Affiliation  AIIMS BHUBANESWAR 
Address  ROOM NO 339,3rd FLOOR,DEPT OF GENERAL MEDICINE, ACADEMIC BLOCK,AIIMS BHUBANESWAR, BHUBANESWAR


ORISSA
751019
India 
Phone  8011605711  
Fax    
Email  genmed_dhriti@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  DR DHRITI SUNDAR DAS 
Designation  ASSOCIATE PROFESSOR, DEPT OF GENERAL MEDICINE 
Affiliation  AIIMS BHUBANESWAR 
Address  ROOM NO 339,3rd FLOOR,DEPT OF GENERAL MEDICINE, ACADEMIC BLOCK,AIIMS BHUBANESWAR, BHUBANESWAR


ORISSA
751019
India 
Phone  8011605711  
Fax    
Email  genmed_dhriti@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
DEPT OF GENERAL MEDICINE,AIIMS BHUBANESWAR,SIJUA,PATRAPADA,BHUBANESWAR,ORISSA,INDIA-751019 
 
Primary Sponsor  
Name  SARANDEV A T V 
Address  ROOM No 411,4TH FLOOR,PG1A,HOSTEL COMPLEX,AIIMS BHUBANESWAR,SIJUA,PATRAPADA,BHUBANESWAR,ORISSA,INDIA-751019 
Type of Sponsor  Other [SELF FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SARANDEV AT V  AIIMS BHUBANESWAR  WARD D6,E6 AND F6 ,DEPARTMENT OF GENERAL MEDICINE
Khordha
ORISSA 		 9961893719

sarandevbhargavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR,Level 3 Academic block,AIIMS Bhubaneswar (At Sijua),Bhubaneswar 751019,Odisha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J189||Pneumonia, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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 randomization given for 5 days or till clinical stability criteria is attained whichever is less along with standard treatment. In all cases, study drug will be stopped after 5 days. 
Comparator Agent  STANDARD TREATMENT ALONE  The standard of care the patients will receive will be according to the ATS(American Thoracic Society)/IDSA(Infectious Disease Society of America ) 2019 guidelines on community acquired pneumonia, which is also mentioned in Harrison latest edition. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.

 		 Over 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
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. 		 Over the period of study 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   23/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

·       Severe CAP has a complicated and diverse aetiology. Although antibiotics are essential for battling the infectious agent, lung damage and the emergence of systemic consequences are mostly dependent on the concomitant hyperinflammatory response. Pentoxifylline has the potential to mitigate the cytokine storm linked to severe CAP by regulating the inflammatory response by inhibiting proinflammatory cytokines such as tumor necrosis factor-alpha (TNF-α). This modulation has the potential to improve oxygenation, reduce lung injury, and eventually improve clinical results. This study aims to evaluate the efficacy and safety of PENTOXIFYLLINE as an adjuvant in hospitalized adults with CAP.

 
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