A study to evaluate the effectiveness and safety of Cefpodoxime Proxetil Tablets in Patients Having Upper Respiratory Tract Infections

Phase 4

• Conditions: Health Condition 1: J069- Acute upper respiratory infection,unspecified

• Registration Number: CTRI/2020/11/028896
• Lead Sponsor: Sun Pharmaceutical Industries Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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 ââ?¬â?? 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:

ïÆ?Ë? 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 >38�ºC/ >100.4�ºF)

Malaise

II. Radiological Criteria:

a. Evidence of acute bacterial sinusitis o

Exclusion Criteria

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 �²-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 patientââ?¬•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. Pati

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with adverse events and serious adverse events who have consumed at least one dose of the study medicationTimepoint: 2 weeks

Secondary Outcome Measures

Name	Time	Method
The efficacy will be evaluated based on clinical outcome at ââ?¬Ë?Test of Cureââ?¬â?¢ 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.Timepoint: 2 weeks;The efficacy will be evaluated based on microbiological outcome at ââ?¬Å?Test of Cureââ?¬? visit: Microbiologically Evaluable- Modified Intention to Treat (ME-mITT) in Pharyngitis/Tonsillitis/Pharyngotonsillitis patients.Timepoint: 2 weeks