| CTRI Number |
CTRI/2019/07/020174 [Registered on: 15/07/2019] Trial Registered Prospectively |
| Last Modified On: |
12/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ORAL MEDICATION IS AS EFFECTIVE AS INJECTABLE MEDICATION IN TREATMENT OF PNEUMONIA |
|
Scientific Title of Study
|
COMPARISON OF EFFICACY OF ORAL AMOXICILLIN VERSUS PARENTERAL CEPHALOSPORIN IN TREATMENT OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA A PROSPECTIVE SINGLE BLINDED PARALLEL DESIGN,RANDOMIZED CONTROL TRIAL IN A TERTIARY CARE HOSPITAL OF METROPOLITAN CITY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUSHANT S MANE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI |
| Address |
DEPARTMENT OF PAEDIATRICS GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9820864049 |
| Fax |
|
| Email |
drsush2006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VAIJNATH T SATHE |
| Designation |
JUNIOR RESIDENT III DEPARTMENT OF PAEDIATRICS |
| Affiliation |
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI |
| Address |
DEPARTMENT OF PAEDIATRICS 1ST FLOOR BALARAM BUILDING GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI
ROOM NO 224 300 RESIDENT HOSTEL GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7720905484 |
| Fax |
|
| Email |
vtsathe1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VAIJNATH T SATHE |
| Designation |
JUNIOR RESIDENT III DEPARTMENT OF PAEDIATRICS |
| Affiliation |
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI |
| Address |
DEPARTMENT OF PAEDIATRICS 1ST FLOOR BALARAM BUILDING GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI
ROOM NO 224 300 RESIDENT HOSTEL GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7720905484 |
| Fax |
|
| Email |
vtsathe1@gmail.com |
|
|
Source of Monetary or Material Support
|
| GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITAL MUMBAI |
|
|
Primary Sponsor
|
| Name |
DR SUSHANT S MANE |
| Address |
DEPARTMENT OF PAEDIATRICS GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI 400008 |
| Type of Sponsor |
Other [SELF] |
|
|
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 VAIJNATH T SATHE |
GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI |
DEPARTMENT OF PAEDIATRIC 1ST FLOOR BALARAM BUILDING WARD 38 AND 39 GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI 400008
Mumbai
MAHARASHTRA |
7720905484
vtsathe1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
INJECTABLE 3rd GENERATION CEPHALOSPORIN |
100 MG/KG/DAY BD FOR 7 TO 10 DAYS |
| Intervention |
ORAL AMOXICILLIN
|
100 MG/KG/DAY TDS 7 TO 10 DAYS
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ALL CHILD IN THE AGE GROUP OF 6 MONTHS TO 12 YEARS ADMITTED IN PAEDIATRIC WARD AND CLINICALLY DIAGNOSED AS UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IRRESPECTIVE OF ETIOLOGY. |
|
| ExclusionCriteria |
| Details |
1. LESS THAN 6 MONTHS OF AGE.
2. CHILD ADMITTED IN PAEDIATRIC INTENSIVE CARE UNIT.
3. CHILD WITH UNDERLYING IMMUNODEFICIENCY INCLUDING ACQUIRED AND CONGENITAL CAUSES.
4. CHILD WITH CO-MORBID CONDITIONS LIKE DENGUE, MEASLES ETC.
5. CHILD WITH UNDERLYING HEREDITARY DISORDER LIKE CYSTIC FIBROSIS, SICKLE CELL DISEASE, DISORDERS OF CILIA ETC.
6. CHILD WITH UNDERLYING ANATOMICAL DISORDER LIKE PULMONARY SEQUESTRATION, LOBAR PNEUMONIA, GASTROESOPHAGEAL REFLUX DISORDER, TRACHEOESOPHAGEAL FISTULA AND BRONCHOPULMONARY DYSPLASIA. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COMPARISON OF EFFICACY OF ORAL AMOXICILIN VERSUS PARENTERAL CEPHALOSPORIN IN CASE OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IN CHILDREN IN TERMS OF DAY OF DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTIC, DURATION OF HOSPITAL STAY |
18 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPARISON OF EFFICACY OF ORAL AMOXICILIN VERSUS PARENTERAL CEPHALOSPORIN IN CASE OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA IN CHILDREN IN TERMS OF DAY OF DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTIC, DURATION OF HOSPITAL STAY |
18 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| 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="4"
Days="15" |
|
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
|
THIS STUDY IS PROSPECTIVE, SINGLE BLINDED, PARALLEL DESIGN, RANDOMIZED CONTROL TRIAL COMPARING THE EFFICACY OF ORAL AMOXICILLIN VERSUS PARENTERAL CEPHALOSPORIN IN TREATMENT OF UNCOMPLICATED COMMUNITY ACQUIRED PNEUMONIA CONDUCTED IN TERTIARY CARE HOSPITAL GRANT GMC AND JJ HOSPTAL, MUMBAI IN PAEDIATRIC WARD OVER THE DURATION OF 18 MONTHS. PRIMARY OUTCOME MEASURES IN TERMS OF DAY DEFERVENSCENCE OF FEVER, DAY OF SETTLEMENT OF RESPIRATORY DISTRESS, DAY OF SUBSIDENCE OF COUGH, DURATION OF ANTIBIOTICS AND DURATION OF HOSPITAL STAY. |