FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/11/028896 [Registered on: 04/11/2020] Trial Registered Prospectively
Last Modified On: 31/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the effectiveness and safety of Cefpodoxime Proxetil Tablets in Patients Having Upper Respiratory Tract Infections 
Scientific Title of Study   An Open Label, Multicentric Study to Evaluate Safety and Efficacy of Cefpodoxime Proxetil Sustained Release Tablets in the Patients Having Mild to Moderate Upper Respiratory Tract Infections 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
ICR/19/008 Version No.2.1; Dated 21/DEC/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Suyog Mehta 
Designation  Senior Vice president and Head India Clinical Research 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai-400063, Maharashtra, India.

Mumbai
MAHARASHTRA
400063
India 
Phone  02243245395  
Fax  02243244343  
Email  suyog.mehta@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maulik Doshi 
Designation  Medical Monitor 
Affiliation  Sun Pharma laboratories Limited 
Address  Sun Pharma laboratories Limited Tandalja, Vadodara-390020 Gujarat

Vadodara
GUJARAT
390020
India 
Phone  02656612829  
Fax  02652354897  
Email  maulik.doshi@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Guruprasad Palekar 
Designation  Deputy General Manager 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063

Mumbai
MAHARASHTRA
400063
India 
Phone  02243246215  
Fax  02243244343  
Email  guruprasad.palekar@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Limited 
Address  Sun Pharmaceutical Industries Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Katiyar  Apollo Specialty Hospital Pvt. Ltd.  14/138, Chunni Ganj, Kanpur-208002, Uttar Pradesh, India
Kanpur Nagar
UTTAR PRADESH 		 9889888080

skatiyarin@gmail.com 
Dr Ambanna Gowda  Citizen Hospital  #14, 2"d Main, Dispensary Road, Kalasipalya, Bangalore 560002
Bangalore
KARNATAKA 		 9845270377

Dr.ambanagowda@gmail.com 
Dr Hemant Ramsharan Gupta  Grant Govt. Medical College and Sir J.J Group of Hospital  OPD No 20, Department of Internal Medicine, old OPD building, Byculla, Mumbai-400008.
Mumbai
MAHARASHTRA 		 9870456888

drhemantgupta@hotmail.com 
Dr Ashil Dilipbhai Manavadaria  Hi-tech Multispeciality Hospital  Room No. 04 Ground floor Sector 3-D, Plot No. 1180, Gh Road, Near Gh-11/2 Bus Stand, Gandhinagar, Gujarat- 382003, India
Gandhinagar
GUJARAT 		 9428047470

drashil.man@gmail.com 
Dr Sanjiv Maheshwari  Jawahar Lal Nehru Medical college  Room No 99, OPD building, Kala Bagh, Ajmer -305001.
Ajmer
RAJASTHAN 		 9460479888

Doctor.sanjiv@gmail.com 
Dr Jay Rajesh Dave  Lotus Multispeciality Hospital  Room No. 03 Second floor, Block N, Krupa Residency, Motera Stadium Road, Motera- Sabarmati, Ahmedabad-380005, Gujarat, India
Ahmadabad
GUJARAT 		 9904043620

authenticentcentre@gmail.com 
Dr Namita Padwal  LTM Medical College & LTM General Hospital  Department of Respiratory Diseases, First Floor, College Building,Dr. Ambedkar Road, Sion, Mumbai-400022
Mumbai
MAHARASHTRA 		 9322252708

nta1960@gmail.com 
Dr Manish Jain  Maharaja Agrasen Superspeciality Hospital   Clincial Research Department, Basement, Room No 9, Maharaja Agrasen Superspeciality Hospital Central spine, Agrasen aspatal marg, sector7, Vidyadhar Nagar, Jaipur, Rajasthan. 302039
Jaipur
RAJASTHAN 		 9414414834

Doctor.maishjain2@gmail.com 
Dr Gangwani Dinesh Kumar  Priyadarshani Nursing Home  201-208, Department of medicine, M-Baria Estate, Kargil nagar road, Opp. Manvel Pada, Talav, Virar (East) Dist Palghar
Thane
MAHARASHTRA 		 9833527266

drgangwanidinesh@gmail.com 
Dr Rajesh Kumar Padhy  Sparsh Hospital and Critical Care (P), Ltd  ENT OPD, Plot No: A/407, Sahid Nagar, Bhubaneswar-751007
Khordha
ORISSA 		 9437166120

rajeshpadhy@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Citizen Hospital Inst. Ethics Committee Citizen Wellness LLP  Approved 
EC_Priyadarshini Nursing Home  Approved 
Hi-Tech Ethics Committee (HEC)  Submittted/Under Review 
IEC Grant Government Medical College & Hospital  Submittted/Under Review 
IEC_Apollo Hospital  Approved 
IEC_Jawahar lal nehru hosp  Approved 
IEC_SparshHosp  Approved 
Institutional Ethics Committee (IEC), Maharaja Agrasen Superspeciality Hospital,  Approved 
Institutional Ethics Committee for Human Research Lokmanya Tilak Medical College (IEC-HR-LTMMC), Staff and research Society  Submittted/Under Review 
Lotus Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
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  Cefpodoxime Proxetil Sustained Release Tablets 200 mg  One tablet once daily with meals for 05 to 10 Days, preferably at same time 
Intervention  Cefpodoxime Proxetil Sustained Release Tablets 400 mg  One tablet once daily with meals for 10 Days, preferably at same time 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria
Modification(s)  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient of either gender aged 12 to 65 years (both inclusive)
2. Patient with body weight ≥ 40 kg
3. Patients who are willing to provide written informed consent/assent to participate in the study. An additional written informed consent will be taken from parent/legally acceptable representative (as applicable) in case assent is taken from patient aged ≥ 12 and < 18 years
4. DISEASE SPECIFIC INCLUSION CRITERIA:
A. Diagnostic criteria for pharyngitis, tonsillitis or Pharyngotonsillitis:
I. Patient with a diagnosis of mild to moderate upper respiratory tract infection (pharyngitis, tonsillitis or Pharyngotonsillitis) based on modified Centor score (McIsaac score) ≥ 3 and positive for rapid antigen test (RADT) during the screening period.
MacIsaac score parameters-Score
a) Body Temperature ≥ 38 oC- 1
b) Absence of cough- 1
c) Swollen, Tender anterior cervical nodes- 1
d) Tonsillar exudate or swelling- 1
e) Age 3-14- 1
Age 15 – 44- 0
45 and above- -1
Cumulative Score ___________
Patients meeting the clinical criteria for pharyngitis, tonsillitis or Pharyngotonsillitis will be included in the study irrespective of the microbiological culture and antibacterial susceptibility results.
Note:
 Throat swab will be obtained from all patients at the time of screening for culture and antibacterial susceptibility testing (as per standard method). The specimen should be obtained from the posterior pharynx and/or the tonsillar pillars.
Patients with isolate(s) resistant to study medication or those who are found culture negative can be continued in the study if they show improvement clinically. Their continuation in the study will be at the discretion of the investigator.
Patients with persistence or worsening in the signs and symptoms of infection after at least 3 doses of treatment with the study medication will be considered as clinical failures and will be withdrawn from the study. Their further treatment will be at the discretion of the investigator. The investigator may withdraw patient at any time during the course of the study if the same is in the best interest of the patient.
B. Diagnostic criteria for acute bacterial sinusitis:
Patient should have a history of symptoms as mentioned below for a minimum of 7 days before screening, without improvement over the 3 days immediately before screening. The symptoms MUST NOT be of more than 4 weeks duration.
I. Clinical Criteria:
a. Symptoms
Patient with a diagnosis of acute bacterial sinusitis based on ATLEAST TWO of the following:
Maxillary tooth pain
Facial pain
Frontal headache
Purulent nasal discharge
New onset fetor oris (bad breath)
Morning cough
Nasal obstruction
b. Signs
A Patient should have ATLEAST ONE of the following signs:
Purulent secretions from sinus ostia on examination
Abnormal sinus transillumination
Pain on palpation over sinuses
Facial swelling
Generalized sign and symptoms that are consistent with a diagnosis of acute bacterial sinusitis but are otherwise nonspecific include:
Fever (temperature >38ºC/>100.4ºF)
Malaise
II. Radiological Criteria:
a. Evidence of acute bacterial sinusitis on paranasal sinus X-ray with occipitomental view (water’s view)
5. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence)
[Note: Woman with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal].
6. A female patient of non-childbearing potential such as (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal.
[Note: Post-menopausal woman will be defined as: Women not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age]
7. A male patient must agree to use adequate contraception from study entry till the last dose of the study medication
 
 
ExclusionCriteria 
Details  Subject will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1. DISEASE SPECIFIC EXCLUSION CRITERIA
1.1. Pharyngitis, Tonsillitis or Pharyngotonsillitis
1.1.1. Patient who is a known carrier (note) of Streptococcus pyogenes based on medical history of the patient
1.1.2. Patient with evidence of pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis
1.2. Acute Bacterial Sinusitis:
1.2.1. Patient with disease history consistent with allergic and other types of rhinitis
1.2.2. Patient with isolated frontal and sphenoidal disease given the different pathophysiology and etiologic pathogens
1.2.3. Patient with cystic fibrosis
1.2.4. Immunocompromised patients or patients with other medical conditions that may affect interpretation of the effect and safety of trial drug
1.2.5. Patient with history or current evidence of nasal polyposis
2. Patient with history of hypersensitivity to Cefpodoxime or other Cephalosporins, penicillin or any other β-lactam class of antibiotics or any of the excipients of the study formulation
3. Patient with history or current evidence of rheumatic or valvular heart disease or glomerulonephritis
4. Patient with evidence of infection of the deep tissues of the upper respiratory tract (e.g., epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (e.g.otitis media, or orbital/periorbital cellulitis)
5. Patient with concurrent symptoms suggestive of viral etiology including conjunctivitis, coryza and cough; diffuse adenopathy or rash suggestive of mononucleosis; rash or arthropathy suggestive of scarlet fever
6. Patient requiring hospitalization for treatment for upper respiratory tract infections
7. Patient requiring parenteral antimicrobial treatment for upper respiratory tract infections
8. Patient with any other concurrent infection that necessitates the use of additional systemic antimicrobial therapy.
9. Patient who had received antibiotic treatment for > 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented)
10. Patient with malabsorption syndrome or other gastrointestinal disease that could affect absorption of oral study medication
11. Patient with history of neoplasia or immunosuppression or on chronic immunosuppressive therapy.
12. Patient with history of HIV, Hepatitis B and HCV
13. Patient who is receiving concurrent treatment with diuretics, anticoagulants and corticosteroids
14. Patient with history of allergies e.g., hives, rashes etc.
15. Patient with significant disease(s) or disorder(s) other than the disease in consideration that in the opinion of the investigator may
15.1. put the patient at risk because of participation in the study or
15.2. interfere with the study evaluations or
15.3. cause concern regarding patient’s ability to participate in the study
16. Pregnant women or breast feeding women
17. Patient with history of substance abuse as per Diagnostic and Statistical Manual (DSM-5) criteria
18. Patient with creatinine clearance of < 30 mL/min or requirement of peritoneal or hemodialysis
19. Patient who are unable or unwilling to comply with the study procedures
20. Patient who have participated in another investigational study within the last 3 months prior to screening
21. Investigators, study personnel, sponsor representatives and their first degree relatives
Note- Carrier: Confirmed presence of the organism in their posterior pharynx, without any of the usual attendant clinical symptoms of acute pharyngitis
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants with adverse events and serious adverse events who have consumed at least one dose of the study medication  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The efficacy will be evaluated based on clinical outcome at ‘Test of Cure’ visit: Clinically Evaluable-Modified Intention to Treat (CE-mITT) and Microbiologically Evaluable- Modified Intention to Treat (ME-mITT) in Pharyngitis/Tonsillitis/Pharyngotonsillitis and CE-mITT in Acute Bacterial Sinusitis patients.  2 weeks 
The efficacy will be evaluated based on microbiological outcome at “Test of Cure” visit: Microbiologically Evaluable- Modified Intention to Treat (ME-mITT) in Pharyngitis/Tonsillitis/Pharyngotonsillitis patients.  2 weeks 
 
Target Sample Size   Total Sample Size="256"
Sample Size from India="256" 
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)   16/11/2020 
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   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a Phase IV, single arm, multicentre, open label study. The study will be conducted at multiple centres in India, having qualified Investigators. The study will be initiated only after the receipt of regulatory and ethics committee (EC) approval.

After obtaining the informed consent/ assent (as applicable), patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment. Throat swab culture will be done for pharyngitis/tonsillitis/Pharyngotonsillitis patients only. After confirming the eligibility, patients will be enrolled by allotting the enrolment number. The enrolled patient will take study medication for either 05 to 10 days (200 mg OD in patients of acute pharyngitis/tonsillitis/Pharyngotonsillitis) OR 10 days (400 mg OD in patients of acute bacterial sinusitis). This will be the treatment period. After the treatment period patient will undergo Follow-up Visit/ Test of Cure Visit/ (Day 04 – 07 after therapy completion, for Acute Pharyngitis, Tonsillitis OR Pharyngotonsillitis) and (Day 01 – 04 after therapy completion, Acute Bacterial Sinusitis). During the study, assessments will be performed as per Schedule of Assessment. 
Close