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
|
|
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
|
|
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 (TEAEs) and clinically significant change physical examination details, vital signs and laboratory investigations during 10 days |