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CTRI Number  CTRI/2024/12/078819 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of oral melatonin in critically ill sepsis patients 
Scientific Title of Study   Effect of enteral melatonin on invasive fungal infection and antifungal susceptibility profile in critically ill sepsis patients: A prospective randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAddetlla Sravani 
Designation  junior resident 
Affiliation  Institute of medical sciences,Banaras Hindu University 
Address  Department of Anaesthesiology,1st floor Sir Sunderlal Hospital, IMS BHU, Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  08919830486  
Fax    
Email  addetlla@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrBadri Prasad Das 
Designation  Associate Professor  
Affiliation  Institute of medical sciences, Banaras Hindu University 
Address  Department of Anaesthesiology,1st floor Sir Sunderlal Hospital, IMS BHU, Varanasi.

Varanasi
UTTAR PRADESH
221005
India 
Phone  9415214623  
Fax    
Email  badriprasad.dash5@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrMunesh kumar Gupta  
Designation  Associate professor 
Affiliation  Institute of medical sciences,Banaras Hindu University 
Address  Department of Microbiology, IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  7073060172  
Fax    
Email  guptamuneshkumar@gmail.com  
 
Source of Monetary or Material Support  
Institute of medical science,BHU,VARANASI,INDIA 221005 
 
Primary Sponsor  
Name  Addetlla Sravani 
Address  Department of Anaesthesiology, Sir Sunderlal Hospital, 1st floor, IMS BHU, Varanasi,India 221005 
Type of Sponsor  Other [] 
 
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 
DrAddetlla Sravani  Sir Sunderlal Hospital,BHU  Intensive care units,Department of Anaesthesiology, Sir Sunderlal Hospital, IMS BHU, Varanasi,221005
Varanasi
UTTAR PRADESH 		 08919830486

addetlla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Medical Sciences institutional ethics commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B377||Candidal sepsis, (2) ICD-10 Condition: B440||Invasive pulmonary aspergillosis, (3) ICD-10 Condition: B460||Pulmonary mucormycosis, (4) ICD-10 Condition: A403||Sepsis due to Streptococcus pneumoniae, (5) ICD-10 Condition: A410||Sepsis due to Staphylococcus aureus, (6) ICD-10 Condition: A413||Sepsis due to Hemophilus influenzae, (7) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms, (8) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  enteral melatonin in critically ill patients  20mg of melatonin in form of 4 doses of 5mg tablets given every 1hourly starting from 9pm through ryles tube  
Comparator Agent  placebo  20mg in form of 5mg every hourly for 4 times starting from 9pm in night  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. patients admitted to ICU within 2 days of hospital admission
2.patients with suspected risk of infections
3.patients with anticipated ICU stay of more than 5 days 
 
ExclusionCriteria 
Details  1.Patients known to be pregnant
2.Patients having allergy to study drug
3.receiving palliative care or not expected to survive more than 12 hrs
4.patients receiving any anticoagulant therapy
5.known to have received another interventional trial that might interact with study drug 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Incidence of invasive fungal infections
2.Susceptibility profile in form of MIC values of antifungal agents
 		 Day 1 of ICU admission
Day 5
Day 7
Day 10
Day 14
Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
1.total days of free antifungal therapy
2.Incidence of bacterial sepsis and septic shock
3.susceptibility profile of bacterial agents
4.ventilator free days
5.length of ICU stay
6.Outcome (sepsis and septic shock, death  		 throughout the 28days of ICU stay or till death, which ever is earlier 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 4 
Date of First Enrollment (India)   10/01/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [badriprasad.dash5@gmail.com].

  6. For how long will this data be available start date provided 26-09-2026 and end date provided 26-09-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
effect of melatonin will be studied on incidence of fungal infections 
Methodology in detail The patients admitted to ICU within 2 days of admission and will be allotted bed in an alternate manner in both the ICUs or wherever beds will be available Nursing staff who will be advised to give either of blinded drugs study drug in group A, placebo In group B as per following dose Then nursing staff will be advised to give tab melatonin 5mg around 9pm along with usual medications followed by 5mg every 1 hour 5mg+5mg+5mg total =20mg PO daily If one patient will be admitted after 12am then next day around at 9pm drug will be given but if patient admitted within 9pm to 12 am then drug will be given as early as possible within 12 am and next dose will be given as usual as other patients dose at around 9pm through ryles tube daily This process will be continued till the patient is admitted or till complication developed in the patient due to study drugs or expiry of the patient ,whichever is early. The required data variables will be collected by a blinded resident doctor
The study population will contain 2 groups 1. Group A where patients will be given the study drug melatonin 20mg in form of 4 doses of 5mg tablets every 1 hourly through ryles tube
 2. Group B where patients will be given placebo 20mg in form of 5mg every hourly for 4 times everyday through ryles tube till icu stay or death

PRIMARY OUTCOME • Incidence of invasive fungal infections fungal sepsis & septic shock. • Susceptibility profile in form of MIC values of antifungal drugs.
 SECONDARY OUTCOME • Total days free of antifungal therapy • Incidence of bacterial sepsis and septic shock . • Susceptibility profile of bacterial agents and use of antibacterial agents . • Ventilator free days. • Length of ICU stay . • vasopressor use. • Outcome sepsis and septic shock reversal, death).
The sample size is 92, taking population proportion as 89 percent a confidence level of 95 percent and a margin of error of 5 percent .Considering a dropout percentage of 10 percent, we aim for a total sample size of 120 

Participants will be followed up daily while on the ICU. Routinely collected clinical data cardiovascular, respiratory and renal physiological variables as well as haematological, biochemical parameters will be recorded on a daily basis. Microbiological blood test including bacterial culture, fungal culture, galactomannan, B 1,3 glucan results along with MIC values of the antifungal agents will be collected during the study period as per protocol till 28th day of ICU stay or death, whichever is earlier. Patients will also be followed up to ascertain survival status at 28 days post recruitment and at hospital discharge.
 
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