| CTRI Number |
CTRI/2020/10/028478 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/10/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Azithromycin in children with acute exacerbation of asthma |
|
Scientific Title of Study
|
Azithromycin as an add-on drug in children aged 5-14 years with acute exacerbation of asthma |
| Trial Acronym |
Azipeds |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kapil Bhalla |
| Designation |
Associate Professor Paediatrics medicine |
| Affiliation |
PT B.D.SHARMA PGIMS ROHTAK |
| Address |
OFFICE OF PEADIATRICS MEDICINE,WARD 14
PT B.D.SHARMA PGIMS ROHTAK
OFFICE OF PEADIATRICS MEDICINE,WARD 14
PT B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9813743565 |
| Fax |
|
| Email |
kapil_bhalla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chetna Tholia |
| Designation |
Junior Resident Peadiatrics |
| Affiliation |
PT..B.D.SHARMA PGIMS, ROHTAK |
| Address |
ROOM NO.53 , BLOCK A GANGA GIRLS HOSTEL,PT.B.D.SHARMA PGIMS ROHTAK
ROOM NO.53 , BLOCK A GANGA GIRLS HOSTEL,PT.B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9992778475 |
| Fax |
|
| Email |
chetna22tholia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetna Tholia |
| Designation |
Junior Resident Peadiatrics |
| Affiliation |
PT..B.D.SHARMA PGIMS, ROHTAK |
| Address |
ROOM NO.53 , BLOCK A, GANGA GIRLS HOSTEL. PT.B.D.SHARMA PGIMS ROHTAK
ROOM NO.53 , BLOCK A GANGA GIRLS HOSTEL,PT.B.D.SHARMA PGIMS ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9992778475 |
| Fax |
|
| Email |
chetna22tholia@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT. B.D.SHARMA PGIMS ROHTAK |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
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 Kapil Bhalla |
PT.B.D. SHARMA PGIMS ROHTAK |
Department of Paediatrics , Pt B.D.Sharma PGIMS Rohtak
Rohtak
HARYANA |
9813743565
kapil_bhalla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, (2) ICD-10 Condition: J459||Other and unspecified asthma, (3) ICD-10 Condition: J453||Mild persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Azithromycin with Standard treatment |
A randomized controlled trial study design will be used. Two hundred will be enrolled in study with hundred patients in each group. The patients will be randomized into two groups using computer generated randomization sequence. In intervention group, the patients will receive oral azithromycin ( Dose Oral 10mg /kg body weight once a day for 3 days) along with standard therapy (inhaled B2 agonist, inhaled and/or systemic corticosteroids) and in control group, patients will receive standard therapy alone |
| Comparator Agent |
Standard treatment |
A randomized controlled trial study design will be used. Two hundred will be enrolled in study with hundred patients in each group. The patients will be randomized into two groups using computer generated randomization sequence. In intervention group, the patients will receive oral azithromycin (Oral 10mg /kg body weight) along with standard therapy (inhaled B2 agonist, inhaled and/or systemic corticosteroids) and in control group, patients will receive standard therapy alone |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
children aged 5-14 years presenting with acute exacerbation of asthma |
|
| ExclusionCriteria |
| Details |
1.Children with heart ,liver ,neurological or kidney diseases.
2. Children with evidence of pneumonia
3. Children with respiratory rate more than 50, or fever more than 39 degree Celsius.
4. Children with abnormal development of airways ,congenital respiratory tract diseases
5. Children with metabolic and autoimmune diseases.
6. Children with known Q-T interval prolongation
7. Children with macrolide allergy
8. Children taking medication which prolongs Q-T interval
9. Children using oral and systemic antibiotic within 28 days of enrollment
10. Children who needs intensive care
11. Children with history of tachyarrhythmia and /or bradyarrhythmia
12. Caregivers who are not willing to give informed written consent
13. Children with recurrent chest infections
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be assessed on day 4 of initial treatment by following parameters :
Duration of respiratory symptoms to resolve i.e.
1. Difficulty in breathing
2. Fast breathing
3. Noisy breathing,
4. Chest tightness or chest pain
5. Persistent cough
6. Any adverse effect of drug like diarrohea , drug allergy , palpitation
|
day of presentation , day 4th ,day 14th
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Detection of IgM Mycoplasma pneumonia in peripheral blood sample by ELISA method in children aged 5-14 years with acuteexacerbation of asthma |
on day of addmission |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
25/10/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present study shall be conducted in Department of Pediatrics, Post Graduate Institute of Medical Sciences, Rohtak. Study participants shall be taken from Pediatrics OPD, Emergency and Pediatrics indoor wards. The study will begin only after seeking approval from institutional ethics committee (IEC). Attendants of children shall be explained about the study and written informed consent shall be taken from them. For children aged more than 7 years consent will be taken from patient also .After taking a thorough history, each participant shall undergo detailed clinical examination, then trial after randomization. A randomized controlled trial study design will be used. Two hundred will be enrolled in study with hundred patients in each group after taking into account of sample size of various previous studies and as per principle of undertaking feasibility and research possibility. Baseline ECG will be done in all patient to rule out any Q-T prolongation. The patients will be randomized into two groups using computer generated randomization sequence. In intervention group, the patients will receive oral azithromycin (Oral 10mg /kg body weight) along with standard therapy (inhaled B 2 agonist, inhaled and/or systemic corticosteroids) and in control group, patients will receive standard therapy alone. Danger signs like allergic reaction, palpitation etc will be explained to attendant of patient who are receiving azithromycin. They will be advised to report in emergency room if any danger sign develops. Both group will be compared in terms of proportion of patient relieved of respiratory symptoms on day 4 and quality of life 14 th day. In all the children Immunoglobulin M (IgM) antibodies will be serologically determined for Mycoplasma pneumoniae. The comparison among two groups will be done on the basis of response to treatment on day 4, quality of life assessment by using Mini PAQLQ score on day 14 . The patients will be assessed on 4 th day and after 2 week. The data thus obtained will be entered in the current version of Microsoft-Excel and percentage proportion will be calculated. Pearson’s chi-squared test and student t test will be applied to test the significance of the results using current version of SPSS (Statistical Package for Social Sciences) software version. P<0.05 will be considered significant.
|