Fixed Dose Combination of Cephalexin Extended Release (375 mg) and Clavulanate Potassium (125 mg) Tablets in the Treatment of Upper Respiratory Tract Infections.

Phase 3

• Conditions: Health Condition 1: null- Upper Respiratory Tract Infections (pharyngitis, tonsillitis or pharyngotonsillitis)

• Registration Number: CTRI/2015/01/005353
• 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: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

1.Subjects of either sex, aged 12 to 75 years (both inclusive), who have given written informed consent/assent including audio visual recording of consent procedure to participate in the study. An additional written informed consent will be obtained from parent/legally acceptable representative (as applicable) in case assent is taken from subjects aged <18 years.

2.Subjects with a diagnosis of acute upper respiratory tract infection (pharyngitis, tonsillitis or pharyngotonsillitis) based on the following signs and symptoms:

Sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least one of the following clinical signs:

a)pharyngeal and/or tonsillar erythema

b)pharyngeal and/or tonsillar exudates

c)cervical adenopathy

d)uvular edema

e)Fever (temperature >38ºC/ >100.4ºF)

Subjects meeting the clinical criteria for pharyngitis and/or tonsillitis will be included in the study irrespective of the microbiological culture and antibacterial susceptibility results.

Note:•Throat swab will be obtained from all subjects at the time of screening for culture and antibacterial susceptibility testing (as per standard methods). The specimen should be obtained from the posterior pharynx and/or the tonsillar pillars.

•Subjects 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.

•Subjects with persistence or worsening in the signs and symptoms of infection after at least 6 doses of treatment with the study medication will be considered as clinical failures and will be withdrawn from the study.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 a subject at any time during the course of the study if the same is in the best interest of the subject.

Exclusion Criteria

1.Subjects with history of hypersensitivity to cephalexin, other cephalosporins, penicillins, clavulanate potassium or other betalactam class of antibiotics or any of the excipients of study formulation.

excipients - Microcrystalline cellulose, Sodium starch glycolate, colloidal anhydrous silica, magnesium stearate, hypromellose, hydroxypropyl cellulose, Talc, PEG 400, titanium dioxide, indigo Carmine and colloidal anhydrous silica.

2.Subjects who are known carriers of Streptococcus pyogenes.

3.Subjects with Infection of the deep tissues of the upper respiratory tract (e.g. epiglottitis, retropharyngeal or buccal cellulitis or abscess of the retropharynx or tonsil or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (e.g. sinusitis, otitis media or orbital/periorbital cellulitis).

4.Subjects 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.

5.Subjects with history of rheumatic or valvular heart disease or glomerulonephritis.

6.Subjects requiring hospitalization or parenteral antibiotic treatment.

7.Subjects who have received antibiotic treatment for greater than or equal to 24 hours during the 72 hours prior to enrollment in the study (unless treatment failure was documented).

8.Subjects with history of neoplasia or immunosuppression or on chronic immunosuppressive therapy or diagnosis of acquired immunodeficiency syndrome (AIDS).

9.Subjects with significant disease(s) or disorder(s) other than the disease in consideration that in the opinion of the investigator may (i) put the subject at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding subjectâ??s ability to participate in the study or (iv) needs an additional anti-microbial agent

10.Pregnant or breast feeding women or women of child-bearing potential not using medically acceptable methods of contraception or women with positive urine pregnancy test (UPT) at screening.

11.Subjects unwilling or unable to comply with the study procedures

12.Subjects who have participated in another investigational study in the previous 3 months prior to enrollment in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical OutcomeTimepoint: Test of Cureâ?? visit (4 â?? 8 days after end of treatment).

Secondary Outcome Measures

Name	Time	Method
Microbiological OutcomeTimepoint: Test of Cureâ?? visit (4 â?? 8 days after end of treatment).