FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019590 [Registered on: 10/06/2019] Trial Registered Prospectively
Last Modified On: 05/11/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Cefdetorin Pivoxil in Childhood respiratory tract infections  
Scientific Title of Study   Effectiveness and Safety of Cefditoren Pivoxil in Childhood Acute Respiratory Tract Infection: A Prospective, Open Label, Single Arm, Unicentric, Phase IV (Post Marketing) Study In India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MC/CEF/D/19-00, Version/Date, 01 / 17th April 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Apurba Ghosh 
Designation  Director 
Affiliation  Institute of Child Health 
Address  Project Room 113, 11, Dr. Biresh Guha Street, Kolkata-

Kolkata
WEST BENGAL
700017
India 
Phone  919830052887  
Fax    
Email  apurbaghosh@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research  
Address  Medclin Research Pvt. Ltd ACROPOLIS, Unit No.10/5, 10th floor, 1858/1, Rajdanga Main Road,

Kolkata
WEST BENGAL
700107
India 
Phone    
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research  
Address  Medclin Research Pvt. Ltd ACROPOLIS, Unit No.10/5, 10th floor, 1858/1, Rajdanga Main Road,

Kolkata
WEST BENGAL
700107
India 
Phone    
Fax    
Email  monjorimr@gmail.com  
 
Source of Monetary or Material Support  
Sponsor (Zuventus Healthcare Ltd.) Office No. 5119, 5th floor, D wing, Oberoi Garden Estates, Chandivli, Andheri (E) Mumbai – 400072 
 
Primary Sponsor  
Name  Zuventus Healthcare Ltd 
Address  Office No. 5119, 5th floor, D wing, Oberoi Garden Estates, Chandivli, Andheri (E) Mumbai  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Apurba Ghosh  Institute of Child Health  Project Room No. 113, 11, Dr. Biresh Guha Street, Kolkata-700017
Kolkata
WEST BENGAL 		 9830052887

apurbaghosh@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Institute of Child Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cefditoren Pivoxil 100mg/5ml  Cefditoren pivoxil 100mg/5ml oral suspension Each enrolled subject will be administered the study drug 3 mg/kg/dose for 10 days to be consumed three times a day, after meals Drug to be administered orally thrice daily for 10 days 
Comparator Agent  Not Applicable as the study is single arm  Not Applicable as the study is single arm 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Children between the age of 1-5 years of both gender, with a clinical diagnosis of acute respiratory tract infection suggestive of a bacterial etiology in the opinion of the investigator and can be managed with oral antibiotic therapy
2. Written informed consent from the parent/guardian
 
 
ExclusionCriteria 
Details  1. Presence of active convulsions, child is unconscious or lethargic, not feeding or vomiting continuously.
2. Presence of chest in-drawing or stridor in a calm child
3. Presence of severe febrile disease complicated severe malnutrition.
4. Use of antibiotics for any other indication in the three weeks prior to enrollment
5. Evidence of any severe bacterial infection requiring parenteral antibiotics.
6. Presence of any severe comorbidities such as haematological or oncological, immunodeficiency, congenital heart disease, neuromuscular impairment, development disorder, including downs syndrome, bronchopulmonary dysplasia, cystic fibrosis, primary ciliary dyskinesia, poorly controlled asthma or other severe chronic lung diseases, which in the opinion of the Investigator renders the subject unfit to participate in the trial.
7. History of known allergy to cefditoren pivoxil or any cephalosporins, penicillins.
8. Participating or planning to participate in another trial that might affect the current study
9. Any reason why, in the opinion of the investigator, the subject should not participate (e.g. not able to comply with study procedures)
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to evaluate the clinical cure rate of Cefditoren Pivoxil in acute respiratory tract infections  Clinical Cure Rate:
Number and proportion of children with clinical cure at end of study visit (Day 11) defined as the disappearance of clinical signs and symptoms observed at baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective of the study is to evaluate the clinical response rate and clinical failure rate of Cefditoren Pivoxil in acute respiratory tract infections and to evaluate the microbiological cure rate in those subjects who had a positive Polymerase Chain Reaction (PCR) for the causative pathogens (Streptococcus pneumoniae, moraxella catarrhalis and Haemophilus influenza) at baseline.  Clinical Response Rate:
Number and proportion of children with clinical improvement at Day 7
Microbiological Cure Rate:
Number and proportion of children who have a negative PCR at the end of the study (day 11) amongst those who had a positive PCR for causative pathogens (Streptococcus pneumoniae, moraxella catarrhalis and Haemophilus influenza) at baseline
Clinical Failure Rate:
Number and proportion of children with unchanged or worsened symptoms at day 7  
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/06/2019 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   The findings of this study may be published in a scientific journal or presented at a scientific meeting with prior permission from the sponsor. The sponsor and the CRO, reserves the right to review all manuscripts prior to submission for publication or any paper before it is presented. Authorship will be determined by mutual agreement between the sponsor in conjunction with the CRO and the Principal investigator(s).  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This clinical trial aims to evaluate the effectiveness and safety of Cefditoren by assessing the percentage of subjects with acute respiratory infections who achieve clinical as well as bacteriological cure after a 10 day course. Clinical cure will be estimated for all enrolled subjects, bacteriological cure will assessed only for those subjects who have had a positive PCR for causative pathogens of hemophilus influenzae, streptococcus pneumoniae and moraxella catarrhalis at baseline.

 
Close