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CTRI Number  CTRI/2020/09/028124 [Registered on: 29/09/2020] Trial Registered Prospectively
Last Modified On: 23/09/2020
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Assess Efficacy and Safety of Zedocef Tablet in URTI Patients 
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 + Clavulanic acid 125 mg versus Amoxicillin 500 mg + Clavulanic acid 125 mg in the Treatment of patients with Upper Respiratory Tract Infections. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-013-CeCl-2019_Version1.0_Dated_12 Dec2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajendra Bohra 
Designation  Principal Investigator 
Affiliation  Mahatma Gandhi Mission Medical College And Hospital 
Address  Department of ENT Mahatma Gandhi Mission Medical College And Hospital N6 CIDCO Auranagabad 431003 Maharashtra India
N6 CIDCO Auranagabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  9225304660  
Fax    
Email  rajbohra@msn.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajendra Bohra 
Designation  Principal Investigator 
Affiliation  Mahatma Gandhi Mission Medical College And Hospital 
Address  Department of ENT Mahatma Gandhi Mission Medical College And Hospital N6 CIDCO Auranagabad 431003 Maharashtra India
N6 CIDCO Auranagabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  9225304660  
Fax    
Email  rajbohra@msn.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajendra Bohra 
Designation  Principal Investigator 
Affiliation  Mahatma Gandhi Mission Medical College And Hospital 
Address  Department of ENT Mahatma Gandhi Mission Medical College And Hospital N6 CIDCO Auranagabad 431003 Maharashtra India
N6 CIDCO Auranagabad
Aurangabad
MAHARASHTRA
431003
India 
Phone  9225304660  
Fax    
Email  rajbohra@msn.com  
 
Source of Monetary or Material Support  
MACLEODS PHARMACEUTICALS LTD 
 
Primary Sponsor  
Name  Dr Rajendra Bohra 
Address  Department of ENT Mahatma Gandhi Mission Medical College And Hospital N-6 CIDCO, Auranagabad-431003, Maharashtra, India.  
Type of Sponsor  Other [Self] 
 
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 Rajendra Bohra  Mahatma Gandhi Mission Medical College And Hospital   Department of ENT Mahatma Gandhi Mission Medical College And Hospital N6 CIDCO Auranagabad 431003 Maharashtra India
Aurangabad
MAHARASHTRA 
919225304660

rajbohra@msn.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Missions Ethics Committee For Research On Human Subjects MGM ECRHS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Tab Clavam  Amoxicillin 500 Plus Clavulanic acid 125 mg Tablets_Twice daily after meal (Approx 12 hr apart) Orally for 10 days 
Intervention  Zedocef CV  Cefpodoxime Proxetil 200mg + Clavulanic acid 125 mg Tab_Twice daily after meal (Approx 12 hr apart) Orally 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
3. Women of childbearing potential must be willing to consistently use an appropriate method of contraception
4. Willingness to give their written informed consent to participate in the study
5. 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
9. Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease
10. Female patient with vaginal fungal infections or vulvovaginal infection
11. Current indication for administration of or treatment with antiviral drugs.
12. 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.
13. Patients requiring hospitalization or parenteral antibiotic treatment.
14. Patients who have received any antibiotic treatment within 2-3 days prior to enrollment in the study.
15. Heavy smoking, alcohol abuse or known or suspected drug addiction.
16. Female patients who are pregnant or lactating or planning to become pregnant.
17. 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.
18. 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   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Cefpodoxime Clavulanic acid versus Amoxicillin 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 in both treatment groups
To determine the worsening in the clinical signs and symptoms of URTI on Day 5 and Day 11 in both treatment groups
Global assessment of treatment improvement in the clinical signs and symptoms of URTI on Day 11 in both treatment groups
To estimate the CRP level on Day 11 in both treatment groups
 
Day 5 and Day 11 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   08/10/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

This is a prospective single center open label randomized parallel group active controlled clinical study of patients with upper respiratory tract infections. Planned Study Site: One site in India with 60 subjects enrollment period will be approx 6 months screening will be upto 7 days and treatment period will be 10 days  primary objective will be To evaluate the efficacy of Cefpodoxime + Clavulanic acid versus Amoxicillin + Clavulanic acid in the clinical signs and symptoms of URTI on Day 11 and primary endpoint will be Proportion of patients with complete cure in the clinical signs and symptoms of URTI at the end of treatment in both treatments groups as assessed by 4-point scale, Safety of the IP as assessed by treatment emergent adverse events (TEAEsand clinically significant change physical examination details, vital signs and laboratory investigations during 10 days 


 
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