FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/05/033684 [Registered on: 19/05/2021] Trial Registered Prospectively
Last Modified On: 13/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study to evaluate the safety and efficacy of Cefpodoxime Proxetil 200 mg and Clavulanic acid 125 mg versus Amoxicillin 500 mg and Clavulanic acid 125 mg in the Treatment of Patients with Upper Respiratory Tract Infections  
Scientific Title of Study   A Prospective Single center Open label Randomized Parallel group Active controlled Clinical Study to Evaluate the Efficacy and Safety of Cefpodoxime Proxetil 200 mg and Clavulanic acid 125 mg versus Amoxicillin 500 mg and Clavulanic acid 125 mg in the Treatment of Patients with Upper Respiratory Tract Infections  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumeet Jagtap  
Designation  Principal Investigator  
Affiliation  Sai Sneh Hospital and Diagnostic Center  
Address  Opposite PMT Bus depot Pune Satara Road Katraj

Pune
MAHARASHTRA
411046
India 
Phone  02026959208   
Fax    
Email  drsumeetjagtap@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumeet Jagtap  
Designation  Principal Investigator  
Affiliation  Sai Sneh Hospital and Diagnostic Center  
Address  Opposite PMT Bus depot Pune Satara Road Katraj

Pune
MAHARASHTRA
411046
India 
Phone  02026959208   
Fax    
Email  drsumeetjagtap@gmail.com  
 
Details of Contact Person
Public Query  
Name  Krishnaa S Upadhye  
Designation  Director  
Affiliation  Krescent Medical Research Pvt Ltd 
Address  B804 Harit shilp Ram Nagar Krushna Colony Rahatani Pune
-
Pune
MAHARASHTRA
411017
India 
Phone  9028293366  
Fax  -  
Email  krishnaa.upadhye@krescentmr.com  
 
Source of Monetary or Material Support  
Macleods Pharmaceuticals Ltd 
 
Primary Sponsor  
Name  Dr Summet Jagtap 
Address  Sai Sneh Hospital and Diagnostic Center Opposite PMT Bus depot Pune Satara Road Katraj Pune Maharashtra 411 046  
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
Macleods Pharmaceuticals Ltd  Research & Development III Plot No 18 Road No 09 Marol MIDC Andheri (East) Mumbai 400 093 Maharashtra, India.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumeet Jagtap  Sai Sneh Hospital and Diagnostic Center   Department of Medicine, First Floor, OPD no 01 Opposite PMT Bus depot Pune Satara Road Katraj
Pune
MAHARASHTRA 		 02026959208

drsumeetjagtap@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sai Sneh Hospital and Diagnostic Centre   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 
Comparator Agent  Amoxicillin 500 Plus Clavulanic acid 125 mg tablets  1 Tablet for two times a day approx 12 hrs apart for 10 days 
Intervention  Cefpodoxime Proxetil 200 mg Plus Clavulanic acid 125 mg tablets  1 Tablet for two times a day approx 12 hrs apart for 10 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult male or female patients aged between 18 to 65 years of age (both ages inclusive)
2. Diagnosed with URTIs with presence of at least four of the following signs and symptoms:
Sneezing
- Runny nose
- Nasal congestion
- Cough
- Fever
- Headache
- Malaise
- Chilliness
- Scratchy throat
- Sore throat
- Hoarseness
- Myalgias
- Post nasal drip
- Purulent rhinorrhea
- Difficulty in swallowing
- Women of childbearing potential must be willing to consistently use an appropriate method of contraception
3 Willingness to give their written informed consent to participate in the study
4 Willingness to comply with all aspects of the protocol
 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to active or inactive ingredients of the IP or other β-lactams (e.g., penicillins and cephalosporins) except study treatment.
2. Patients with known history of clostridium difficile-associated diarrhea
3. History of renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, serum sickness-like reaction, hemorrhage, agranulocytosis, and pancytopenia
4. History of patients with mononucleosis
5. Present chronic inflammatory ENT and respiratory tract disease
6. Obstructive anatomic lesions in the nasopharynx
7. Patients with severe or complicated course of the URTIs
8. Patients with signs of acute lower respiratory tract disease
8. Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease
9. Female patient with vaginal fungal infections or vulvovaginal infection
10. Current indication for administration of or treatment with antiviral drugs.
11. Treatment with glucocorticosteroids, immunomodulators, or antihistamines during the past 4 weeks prior to or at enrolment as well as current indication requiring these drugs during the trial.
12. Patients requiring hospitalization or parenteral antibiotic treatment.
13. Heavy smoking, alcohol abuse or known or suspected drug addiction.
14. Female patients who are pregnant or lactating or planning to become pregnant.
15. Evidence or history of clinically significant medical or surgical abnormality including clinically significant laboratory parameters that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses if the disease exacerbates during the study.
16. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Cefpodoxime plus Clavulanic acid versus Amoxicillin plus Clavulanic acid in the clinical signs and symptoms of URTI on Day 11  Day 11 
 
Secondary Outcome  
Outcome  TimePoints 
- To determine the improvement in the clinical signs and symptoms of URTI on Day 5 and Day 11
- determine the worsening in the clinical signs and symptoms of URTI on Day 5 and Day 11
- Global assessment of treatment improvement in the clinical signs and symptoms of URTI on Day 11

Safety Objective
Safety and tolerability of the investigational product
 		 Day 5 and Day 11 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/05/2021 
Date of Study Completion (India) 18/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This is a prospective, single-center, open-label, randomized, parallel-group, active-controlled clinical study to evaluate the efficacy and safety of Cefpodoxime proxetil 200 mg + Clavulanic acid 125 mg versus Amoxicillin 500 mg + Clavulanic acid 125 mg in the treatment of patients with upper respiratory tract infections

There are 5 scheduled study site visits during the entire study period; Visit 1 (Screening period/Up to 7 days), Visit 2 (Randomization/Start of study treatment with IP), Visit 3 (Treatment period/Day 5 (±2 days), Visit 4 (End of treatment [EOT]/Day 11 (±2 days) and End of study (EOS)/Telephonic safety follow-up after 3 days of last dose of IP, Individual participation of the patient in the study will last for up to 20 days

Patients will undergo screening study procedures and assessments upon signing of informed consent form (ICF). Detailed medical/surgical, prior and concomitant medication details will be asked from patients and recorded 

Upon screening assessments and procedures, a total of 60 patients will be randomized in 1:1 ratio to receive treatment from any one study treatment groups.




 
Close