| CTRI Number |
CTRI/2025/08/092307 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Burden of Brucella among children with fever for more than 7 days |
|
Scientific Title of Study
|
Burden of Brucella Among Children children presenting with fever for more than 7 days: A comparative cross-sectional study from a tertiary care center in northern India |
| 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 Anuradha Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 19 B
Department of Paediatrics,
Maulana Azad Medical College,
2 Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9560540222 |
| Fax |
|
| Email |
dr.anuradha241096@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,
Maulana Azad Medical College,
2 Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Agarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,
Maulana Azad Medical College,
2 Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9810409625 |
| Fax |
|
| Email |
doctoranuragagarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
2, Bahadurshah Zafar Marg,New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Gupta |
Maulana Azad Medical College |
Department of Paediatrics,
Maulana Azad Medical College,
2 Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI |
09560540222
dr.anuradha241096@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Minor Ailments |
| Patients |
(1) ICD-10 Condition: A239||Brucellosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA FOR GROUP 1:
Children aged 1 to 12 years presenting with any of the following symptoms:
1. Fever lasting more than 7 days without a known cause.
2. Joint pain (intermittent or migratory pain in large or small joints, or both, with or without limitation of
movement).
3. Acute meningoencephalitis (presents with altered sensorium for more than 24 hours and at least one of the
following features: fever, seizures, or focal neurological deficit, with cerebrospinal fluid showing more than 5
cells, glucose less than 2/3 of normal, and protein more than 45 mg/dl).
4. Deep-seated abscess, such as liver abscess or splenic abscess (USG of the whole abdomen proven).
5. Fever with hepatomegaly, splenomegaly, or both.
INCLUSION CRITERIA FOR GROUP 2:
Children aged 1-12 years presenting with:
• Minor ailments. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA FOR GROUP 1:
1. Tested positive for any known cause.
EXCLUSION CRITERIA FOR GROUP 2:
• None. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with
fever +/- joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or
hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days. |
Primary outcome:
• Prevalence of IgG and IgM anti-brucellosis antibodies among children aged 1 to 12 years presenting with
fever or joint pain or acute meningoencephalitis or abdominal pain or deep-seated abscesses or
hepatomegaly or splenomegaly or hepatosplenomegaly or cough or coryza for more than 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome
Proportion of children positive for IgM & IgG antibodies against brucellosis with or without brucella-like symptoms.
Association with brucella with sociodemographic factors like contact with animals or exposure to excreta or urine of animals, & consumption of raw or unpasteurized milk & milk products.
|
Secondary Outcome
Proportion of children positive for IgM & IgG antibodies against brucellosis with or without brucella-like symptoms.
Association with brucella with sociodemographic factors like contact with animals or exposure to excreta or urine of animals, & consumption of raw or unpasteurized milk & milk products.
|
|
|
Target Sample Size
|
Total Sample Size="244"
Sample Size from India="244"
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)
|
01/09/2025 |
| 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 - NO
|
|
Brief Summary
|
Brucella is a zoonotic disease transmitted to humans through infected animals. It has considerable public health implications, especially in regions with inadequate food safety measures, hygiene standards, and veterinary care.1 It is endemic in areas such as the Mediterranean, the Middle East, Central and South America, and India. Due to its non-specific signs and symptoms, the disease often gets neglected.1 From the initial site of infection, the organisms spread via lymphatic vessels, infecting the local lymph glands. This leads to organisms spilling over into the bloodstream, resulting in bacteraemia, which disseminates throughout the body to involve various organs. The primary mode of disease acquisition among children is through contact with animals, exposure to the urine and feces of animals, and consumption of raw or unpasteurized milk or milk products. Considering the varied signs and symptoms, clinical diagnosis of childhood brucellosis is very difficult. Often, incorrect diagnoses occur, and sometimes it may not be possible to diagnose a disease due to a lack of testing facilities. The study aims to produce data that helps determine the prevalence of brucellosis among children and highlights the importance of considering it in differential diagnoses.2 |