ORAL MEDICATION IS AS EFFECTIVE AS INJECTABLE MEDICATION IN TREATMENT OF PNEUMONIA

Phase 2/3

Not yet recruiting

• Conditions: Pneumonia, unspecified organism,

• Registration Number: CTRI/2019/07/020174
• Lead Sponsor: DR SUSHANT S MANE

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-15
• Last Update Posted: 2019-12-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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.

Exclusion Criteria

• LESS THAN 6 MONTHS OF AGE.
• CHILD ADMITTED IN PAEDIATRIC INTENSIVE CARE UNIT.
• CHILD WITH UNDERLYING IMMUNODEFICIENCY INCLUDING ACQUIRED AND CONGENITAL CAUSES.
• CHILD WITH CO-MORBID CONDITIONS LIKE DENGUE, MEASLES ETC.
• CHILD WITH UNDERLYING HEREDITARY DISORDER LIKE CYSTIC FIBROSIS, SICKLE CELL DISEASE, DISORDERS OF CILIA ETC.
• CHILD WITH UNDERLYING ANATOMICAL DISORDER LIKE PULMONARY SEQUESTRATION, LOBAR PNEUMONIA, GASTROESOPHAGEAL REFLUX DISORDER, TRACHEOESOPHAGEAL FISTULA AND BRONCHOPULMONARY DYSPLASIA.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI; 🇮🇳 Mumbai, MAHARASHTRA, India

GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ GROUP OF HOSPITALS MUMBAI

🇮🇳Mumbai, MAHARASHTRA, India

DR VAIJNATH T SATHE

Principal investigator

7720905484

vtsathe1@gmail.com