| CTRI Number |
CTRI/2020/03/023836 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive study |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL PROFILE OF MYCOPLASMA PNEUMONIA INFECTION AMONG CHILDREN WITH PNEUMONIA |
|
Scientific Title of Study
|
CLINICO EPIDEMIOLOGICAL PROFILE OF CHILDREN WITH MYCOPLASMA PNEUMONIA AMONG COMMUNITY ACQUIRED PNEUMONIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PREM SURULIRAJ A |
| Designation |
Post graduate |
| Affiliation |
Institute of child health and hospital for children |
| Address |
DEPARTMENT OF PAEDIATRICS,
M3 UNIT,
E BLOCK- SIXTH FLOOR,
Institute of child health and hospital for children,
Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9788743795 |
| Fax |
|
| Email |
seleco1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Kalpana |
| Designation |
Associate professor |
| Affiliation |
Institute of child health and hospital for children |
| Address |
Institute of child health and hospital for children,
Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9840720234 |
| Fax |
|
| Email |
drskalpana@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
PREM SURULIRAJ A |
| Designation |
Post graduate |
| Affiliation |
Institute of child health and hospital for children |
| Address |
DEPARTMENT OF PAEDIATRICS,
M3 UNIT,
E BLOCK- SIXTH FLOOR,
Institute of child health and hospital for children,
Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9788743795 |
| Fax |
|
| Email |
seleco1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of basic medical sciences, taramani, chennai. |
|
|
Primary Sponsor
|
| Name |
Institute of child health and hospital for children |
| Address |
Institute of child health and hospital for children,
Egmore,
Chennai. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| PREM SURULIRAJ A |
Institute of child health and hospital for children |
Department of paediatrics,
M3 unit,
E block- sixth floor.
Chennai
TAMIL NADU |
9788743795
seleco1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, madras medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J157||Pneumonia due to Mycoplasma pneumoniae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.All children between 2 months to 12 years of age admitting with symptoms suggestive of community acquired pneumonia as per the WHO criteria (Cough, cold, fast breathing and chest indrawing |
|
| ExclusionCriteria |
| Details |
1.Children with aspiration pneumonia with neurodevelopmental delay
2.Children with hospital acquired pneumonia( pneumonia developing 72 hrs after admission or within 7 days of discharge)
3.Children with co morbid conditions prone to cause recurrent pneumonias(congenital heart diseases, airway anomalies, cystic fibrosis,congenital or acquired immunodeficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to identify any specific clinical markers that helps in the diagnosis of mycoplasma and reduce the usage of unwarranted and empirical macrolides in community acquired pneumonia cases. |
February 2020 to february 2021 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study also aims to identify the sensitivity pattern of the mycoplasma pneumonia to macrolides. |
February 2020 to february 2021 |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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)
|
01/02/2021 |
| 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
|
The sensitivity pattern of mycoplasma pneumoniae among children with community acquired pneumonia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Children between 2 months and 12 yrs of age with bronchopneumonia fullfilling the revised WHO criteria are recruited under the study. Induced sputum specimen will be taken and analysed for the prevalence of mycoplasma among CAP based on culture. Its sensitivity pattern for macrolides will also be analysed based on PCR. |