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CTRI Number  CTRI/2025/07/091769 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Profile of children with fever more than 5 days 
Scientific Title of Study   CLINICO-ETIOLOGICAL PROFILE OF CHILDREN PRESENTING WITH FEVER MORE THAN OR EQUAL TO 5 DAYS 
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 Virendra Kumar 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India 
Phone  9313985662  
Fax    
Email  drvkumar1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Virendra Kumar 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India 
Phone  9313985662  
Fax    
Email  drvkumar1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Virendra Kumar 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Pediatrics
2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI
110002
India 
Phone  9313985662  
Fax    
Email  drvkumar1@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital 2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 India 
 
Primary Sponsor  
Name  Department of Pediatrics Maulana Azad Medical College and associated Lok Nayak Hospital 
Address  2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002 India Delhi 
Type of Sponsor  Government medical college 
 
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 
Dr Virendra Kumar  Maulana Azad Medical College and associated Lok Nayak Hospital  Department of Pediatrics 2, Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi, 110002
Central
DELHI 		 09313985662

drvkumar1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  presenting with fever of more than or equal to 5 days 
 
ExclusionCriteria 
Details  children who are previously diagnosed cases of immunodeficiency, chronic systemic diseases or congenital anomalies. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of children presenting with infectious and non-infectious etiologies of acute febrile illness.  at the end of study that is 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of children with various etiologies in different age groups (less than 1 year, 1year to 3 years, & 3 years to 12 years)
2. Proportion of children discharged within 14 days
3. Proportion of children sensitive to initial empirical antibiotics
 		 at the end of the study that is 3 months 
 
Target Sample Size   Total Sample Size="134"
Sample Size from India="134" 
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   N/A 
Date of First Enrollment (India)   25/08/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Fever is defined as rectal body temperature of >38°C (100.4°F), and is a common clinical symptom in pediatric age group.(nelson) The epidemiology of fever keeps on changing with the changes in host factors, climate, immunization, and various socioeconomic factors. It is thus our attempt to know the pattern as well as highlight the various risk factors of fever, so as to take steps to improve those factors. A thorough history, examination as well as multiple investigations are to be done to know the cause of fever without localising signs. The rampant use of antibiotics have increased antibiotic resistance in the population. This study wants to highlight the clinico-etiological profile of fever in children with emphasis on environmental and epidemiological risk factors so as to lay out future directive policies for their prevention at the community level and promoting rational use of antibiotics.   

 
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