| CTRI Number |
CTRI/2024/09/074086 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Antimicrobial adverse effects seen in less than 18 years old children suffering from lower respiratory tract infection and their prescribing pattern in OPD/IPD |
|
Scientific Title of Study
|
Antimicrobial prescribing pattern associated adverse drug reaction in lower respiratory tract infection in pediatric age group of less than 18 years presenting at Rama Medical College Hospital and Research Centre ,Kanpur |
| 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. Syed Shadman Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Rama Medical College Mandhana |
| Address |
Department Of Pharmacology And Therapeutics,Rama Medical College Mandhana Kanpur Uttar Pradesh India
Room no. 2156 Department of Pharmacology , Rama Medical College Mandhana Kanpur Uttar Pradesh India
Kanpur Nagar
UTTAR PRADESH
209217
India |
| Phone |
9835080198 |
| Fax |
|
| Email |
shadman2371@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Syed Shadman Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Rama Medical College Mandhana |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College Mandhana Kanpur Uttar Pradesh India
Department of Pharmacology and Therapeutics , Rama Medical College Mandhana Kanpur Uttar Pradesh India
UTTAR PRADESH
209217
India |
| Phone |
9835080198 |
| Fax |
|
| Email |
shadman2371@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malika Trivedi |
| Designation |
Junior Resident |
| Affiliation |
Rama Medical College Mandhana |
| Address |
Department Of Pharmacology and Therapeutics,Rama Medical College Mandhana Kanpur Uttar Pradesh India
330,Vikas Nagar Kanpur Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
9839927927 |
| Fax |
|
| Email |
docmalik@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology and Pediatrics |
|
|
Primary Sponsor
|
| Name |
Rama Medical college ,hospital and research centre |
| Address |
Mandhana ,kanpur Uttarpradesh |
| Type of Sponsor |
Private 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 Syed Shadman Ahmad |
RAMA MEDICAL COLLEGE & HOSPITAL |
ROOM NO. 1, DEPARTMENT OF PEDIATRICS UNIT 1
Kanpur Nagar
UTTAR PRADESH |
9835080198
shadman2371@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee Rama Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J219||Acute bronchiolitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
ANYinfant / child with one or more of the folloing :
H/O Fever
H/O Cough
H/O Wheeze
H/O Shortness of breath
H/O Hoarseness of voice
H/O Adventitious sounds |
|
| ExclusionCriteria |
| Details |
Child/Infant with significant hepatic and renal dysfunction
Child /infant with congenital anomalies
Child /infant with major illnesses like epilepsy ,intelectual disability , tuberculoma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effects of antimicrobials pediatric age group less than 18 years in respiratory tract infection |
0 weeks, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE |
DAY 0, 4th WEEK, 8th WEEK, 12 th WEEK |
|
|
Target Sample Size
|
Total Sample Size="131"
Sample Size from India="131"
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)
|
20/09/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
PATIENTS ADMITTED IN IPD WITH DIAGNOSIS OF LRTI WILL BE TAKEN ON CHARACTERISTICS SUCH AS AGE ,SEX, BODY WEIGHT, CASES WITH PREVIOUS DRUG HISTORY, DURATION OF HOSPITALIZATION WILL BE NOTED ALL PATIENTS WITH LRTI’S WILL BE MONITORED FOR ADR’s IN WARD DURING HOSPITAL STAY DAILY TILL DISCHARGE AND FOLLOW UP ON 5th - 7th DAY , SERIOUS CASES CAN BE MONITORED UP TILL 14 th DAY AFTER DISCHARGE WHEN A SUSPECTED ADR IS ENCOUNTERED , DATA OF THE DRUG AND REACTION WILL BE DOCUMENTED IN A SUITABLY DESIGNED ADR DOCUMENTATION FORM OR PROFORMA THAT INCLUDED THE DRUG NAME ,DOSAGE,ROUTE AND FREQUENCY OF CONSUMPTION ALONG WITH DETAILS OF ADR |