| CTRI Number |
CTRI/2022/06/043246 [Registered on: 14/06/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on the cause of body temperature variation |
|
Scientific Title of Study
|
Evaluation of a clinical score to differentiate between bacterial and non bacterial etiology in the first 4 days of a febrile illness in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
| No |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDhanya Dharmapalan |
| Designation |
Consultant Pediatric Infectious Diseases |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Infectious Disease
CBD Belapur, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400414
India |
| Phone |
9820274280 |
| Fax |
|
| Email |
drdhanyaroshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDhanya Dharmapalan |
| Designation |
Consultant Pediatric Infectious Diseases |
| Affiliation |
Apollo Hospitals |
| Address |
Department of Infectious disease
CBD Belapur, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400414
India |
| Phone |
9820274280 |
| Fax |
|
| Email |
drdhanyaroshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDhanya Dharmapalan |
| Designation |
Consultant Pediatric Infectious Diseases |
| Affiliation |
Apollo Hospitals |
| Address |
Department of infectious disease
CBD Belapur, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400414
India |
| Phone |
9820274280 |
| Fax |
|
| Email |
drdhanyaroshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Academy of Pediatrics, Mumbai (IAPM)
Navi Mumbai Association of Pediatrics |
|
|
Primary Sponsor
|
| Name |
Indian Academy of Pediatrics Mumbai IAPM |
| Address |
1st Floor, 92/4, GEETA BUILDING, Dr. B.AMBEDKAR ROAD, SION EAST, Mumbai Suburban Maharashtra, 400022 |
| Type of Sponsor |
Other [Independent Association] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Navi Mumbai Association of Pediatrics |
Society Reg No Maha/2063/09/ Shop No 3, Satyam Harmony,Sector 9, Koperkhairne, Thane, Navi Mumbai-400709 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 24 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Naresh Thakker |
Anand Children’s Nursing Home |
Andheri E , Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9821701207
nareshthakker@hotmail.com |
| Dr Dhanya Dharmapalan |
Apollo Hospitals |
CBD Belapur, Navi Mumbai- 400414
Thane
MAHARASHTRA |
9820274280
drdhanya_d@apollohospitals.com |
| Dr VN Yewale |
Apollo Hospitals |
CBD Belapur, Navi Mumbai- 400414
Thane
MAHARASHTRA |
9322243465
drvijay_y@apollohospitals.com |
| Dr Bakul Parekh |
Bakul Parekh Children’s Hospital and tertiary care center |
Ghatkopar E, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9821212887
bakulparekh55@gmail.com |
| Dr Pranjal Sathe Kale |
Bandra East Nursing Home |
Bandra E, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9892099023
sathekalepranjal@gmail.com |
| Dr Subhash Rao |
Child Care Clinic |
Sector 14, Vashi, Navi Mumbai
Thane
MAHARASHTRA |
9820374656
doctorsnrao@yahoo.com |
| Dr Suhas Kharche |
Colours Multispeciality Hospital for Children |
Kharghar, Navi Mumbai
Thane
MAHARASHTRA |
9623446339
drsuhaskharche@gmail.com |
| Dr Amin Kaba |
Dawood multispeciality hospital |
Nagpada, Mumbai
Mumbai
MAHARASHTRA |
9323547725
aminkaba@gmail.com |
| Dr Amruta Shirodkar |
Dr Amruta Shirodkar’s Clinic |
Bandra E, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9833126722
dramruta@yahoo.com |
| Dr Prashant Weekey |
Dr Prashant’s Children’s Clinic |
Kopar Khairne, Navi Mumbai
Thane
MAHARASHTRA |
9820098075
prashantweekey@yahoo.co.in |
| Dr Sudhir Sane |
Dr Sane’s clinic |
Thane W, Mumbai
Thane
MAHARASHTRA |
9821056673
sudhirs4@gmail.com |
| Dr Rajesh Chokhani |
Health Care for Children |
Bandra W, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9324810101
rajeshchokhani@gmail.com |
| Dr Suhas Warad |
Jack N Jill Clinic |
Seawoods, Sector 40, Navi Mumbai
Thane
MAHARASHTRA |
8850321763
drsuhasw@hotmail.com |
| Dr Mitesh Shah |
Mahavir Nursing Home |
Ghatkopar W, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9323990545
drmiteshbshah@hotmail.com |
| Dr Praveen Mody |
Mody Hospital |
Airoli Sector 2, Navi Mumbai
Thane
MAHARASHTRA |
9619057916
praveen.mody@yahoo.in |
| Dr Shanthala Murthy |
Raghunath Children Clinic |
Kharghar, Navi Mumbai
Thane
MAHARASHTRA |
9930883881
drshanthala@gmail.com |
| Dr Jeetendra Gavhane |
Rainbow Child Care |
Vashi, Sector 16, Navi Mumbai
Thane
MAHARASHTRA |
9870106094
drjeetendra@gmail.com |
| Dr Kamlakar Chaudhari |
Rainbow Kidz hospital |
Wadala E, Mumbai
Mumbai
MAHARASHTRA |
9821173170
dockvc@yahoo.com |
| Dr Satish Shahane |
Saanvi Children’Hospital |
Kharghar sector 20, Navi Mumbai
Thane
MAHARASHTRA |
9082731050
drshahane@rediffmail.com |
| Dr Mahesh Mohite |
Sai Child Care Hospital |
New Panvel, Navi Mumbai
Thane
MAHARASHTRA |
9833846688
mahesh.mohite180@gmail.com |
| Dr Aditi Shah |
Small Wonders Childrens clinic |
Santacruz W, Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9820260136
aditirj@gmail.com |
| DrAshok Tapaswi |
TAPASWI Child & Eye care clinic |
Navi Mmmbai
Thane
MAHARASHTRA |
9820748172
tapaswi.ashok@gmail.com |
| Dr Nehal Shah |
The Apollo Clinic |
Colaba, Mumbai
Mumbai
MAHARASHTRA |
9820341161
nehalshah73@gmail.com |
| Dr Asmita Patil |
Yewale’s Multispeciality Hospital for children, |
Vashi, Navi Mumbai
Thane
MAHARASHTRA |
9987684223
drasmi123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 24 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
| Institutional Ethics Committee - Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R509||Fever, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Healthy children between age of 6 months
and 18 years presenting with acute onset of
fever of short duration without exposure to
antibiotics in last two weeks |
|
| ExclusionCriteria |
| Details |
Children with following diseases
acute severe acute malnutrition, known
congenital defects or diseases, serious
situations (Behavior change, poor urine
output, respiratory distress, hemodynamic
instability, purpuric rash or gangrenous skin,
meningeal signs).
Children who have received antibiotics in the
first 48 hrs since the onset of fever.
Post vaccination fever |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate a clinical score to suspect or rule out acute bacterial infection during first 3-4 days of fever by analysis of detailed history |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the proportion of children in whom use of antibiotics is not justified.
To evaluate the utility of the tool to reduce irrational use of antibiotics among children |
14 days |
|
|
Target Sample Size
|
Total Sample Size="2115"
Sample Size from India="2115"
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)
|
30/06/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is a high prevalence of antimicrobial resistance among the bacterial isolates of blood stream infections among Indian children. Misuse of antibiotics is an important factor for accelerating the resistance mechanisms among bacteria. Presently physicians rely on their clinical skills to decide on prescribing an antibiotic and these skills vary from individual to individual. There is a clear need for a clinical scoring tool which can be conveniently utilized in the first visit of a child presenting with an acute febrile illness and which can most accurately rule out bacterial infections requiring antibiotics in the first four days of illness. For a better acceptance, this tool needs to be reliable, inexpensive, non invasive and simple for use in a resource limited setting
The data obtained regarding the characteristics of fever will be converted into a score.
This will be used to put down a provisional diagnosis of bacterial infection or no bacterial infection.
Bacterial infection is assigned lower points and higher points for other causes. Points are assigned as per the importance of relevance for differentiation. Inter-febrile period is the most important point of difference and hence assigned 3 points in favour of non-bacterial and 0 point for bacterial infection.
An independent observer will record the observations/data required to use the clinical tool without interfering with the patient management by the primary pediatrician. Therefore there are no indirect or direct benefit or risk to the patients during the study.
|