| CTRI Number |
CTRI/2024/04/065187 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To understand the outcomes of treating children with antibiotic and without antibiotic in uncomplicated upper respiratory tract infection. |
|
Scientific Title of Study
|
A study to evaluate and compare the outcome of no antibiotic use versus immediate antibiotic use in children with uncomplicated upper respiratory tract infection- A randomised control study. |
| 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 Jagdish Singh |
| Designation |
Senior professor, paediatrics |
| Affiliation |
SMS medical college, jaipur |
| Address |
Unit 5, department of pediatrics, J.K.LON Hospital, S.M.S Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928355561 |
| Fax |
|
| Email |
singh.jagdish.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagdish Singh |
| Designation |
Senior professor, paediatrics |
| Affiliation |
SMS medical college, jaipur |
| Address |
Unit 5, department of pediatrics, J.K.LON Hospital, S.M.S Medical College, Jaipur.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928355561 |
| Fax |
|
| Email |
singh.jagdish.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmiprasad |
| Designation |
Junior resident, pediatrics |
| Affiliation |
SMS medical college, Jaipur |
| Address |
Department of pediatrics, S.P.I.N.C.H , SMS medical college, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9880066140 |
| Fax |
|
| Email |
laxmiprasadjaguar29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics,S.P.I.N.C.H, SMS medical college, Jaipur |
|
|
Primary Sponsor
|
| Name |
Sms medical college |
| Address |
S.P.I.N.C.H, Gangawal park, adarsh nagar, jaipur |
| 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 Laxmiprasad |
S.M.S Medical college |
Department of pediatrics, Medical unit 5, Sir Padampat Institute of Neonatal and Child Health
Jaipur
RAJASTHAN |
9880066140
laxmiprasadjaguar29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S.M.S Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
antibiotic group(Amoxyclav or azithromycin) |
giving antibiotic(amoxyclav 30 mg/kg/dose three times a day) through oral route for 5-7 days on day 1 to children with upper respiratory infection and followed up after 48 hours, 7 days and 14 days. |
| Comparator Agent |
no antibiotic group |
no antibiotic given to children with upper respiratory tract infections as per standard treatment guidelines. children will be follwed up after 48hours, 7 days and 14 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.presenting at pediatric outdoor with signs and symptoms of upper respiratory tract infection
2. duration of illness less than 3 days
3. provided written consent |
|
| ExclusionCriteria |
| Details |
1.diagnosis of tuberculosis, pneumonia, ARDS
2. any complicated respiratory tract infection requiring admission to indoor department.
3. chronic respiratory illness.
4.reactive airway disease.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
duration of symptoms of upper 1.respiratory tract infection as calculated to the point when symptoms disappear
2.severity of infection as assessed by scoring on a 7 point linkert scale |
Outcome will be assessed after 48 hours, 7 days and 14 days of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. use of antibiotics during entire coarse of illness
2. parental satisfaction assessed on a 6 point linkert scale |
5-15 days |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="0"
Months="6"
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
|
Majority of upper respiratory tract infection are of viral origin and are often self limiting. Antibiotic prescription in URTI’s are inappropriately very high.Therefore the purpose of the study is to reduce the irrational use of antibiotic in URTI’s in children in india. |