Clinical Study to evaluate the safety and efficacy of Cefpodoxime Proxetil 200 mg and Clavulanic acid 125 mg versus Amoxicillin 500 mg and Clavulanic acid 125 mg in the Treatment of Patients with Upper Respiratory Tract Infections

Completed

• Conditions: Acute upper respiratory infection,unspecified,

• Registration Number: CTRI/2021/05/033684
• Lead Sponsor: Dr Summet Jagtap

Brief Summary

This is 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

There are 5 scheduled study site visits during the entire study period; Visit 1 (Screening period/Up to 7 days), Visit 2 (Randomization/Start of study treatment with IP), Visit 3 (Treatment period/Day 5 (±2 days), Visit 4 (End of treatment [EOT]/Day 11 (±2 days) and End of study (EOS)/Telephonic safety follow-up after 3 days of last dose of IP, Individual participation of the patient in the study will last for up to 20 days

Patients will undergo screening study procedures and assessments upon signing of informed consent form (ICF). Detailed medical/surgical, prior and concomitant medication details will be asked from patients and recorded

Upon screening assessments and procedures, a total of 60 patients will be randomized in 1:1 ratio to receive treatment from any one study treatment groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-24
• Study Completion: 2021-08-18
• Last Update Posted: 2022-04-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.
• Chilliness.
• Scratchy throat.
• Sore throat.
• Hoarseness.
• Post nasal drip.
• Purulent rhinorrhea.
• Difficulty in swallowing.
• Women of childbearing potential must be willing to consistently use an appropriate method of contraception 3 Willingness to give their written informed consent to participate in the study 4 Willingness to comply with all aspects of the protocol.

Exclusion Criteria

• Patients with known hypersensitivity to active or inactive ingredients of the IP or other β-lactams (e.g., penicillins and cephalosporins) except study treatment.
• 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 8.
• Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease 9.
• 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.
• Patients requiring hospitalization or parenteral antibiotic treatment.
• Female patients who are pregnant or lactating or planning to become pregnant.
• 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.
• Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Cefpodoxime plus Clavulanic acid versus Amoxicillin plus Clavulanic acid in the clinical signs and symptoms of URTI on Day 11	Day 11

Secondary Outcome Measures

Name	Time	Method
- To determine the improvement in the clinical signs and symptoms of URTI on Day 5 and Day 11	- determine the worsening in the clinical signs and symptoms of URTI on Day 5 and Day 11

Trial Locations

Locations (1)

Sai Sneh Hospital and Diagnostic Center; 🇮🇳 Pune, MAHARASHTRA, India

Sai Sneh Hospital and Diagnostic Center

🇮🇳Pune, MAHARASHTRA, India

Dr Sumeet Jagtap

Principal investigator

02026959208

drsumeetjagtap@gmail.com