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
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecified
- Registration Number
- CTRI/2021/05/033684
- Lead Sponsor
- Dr Summet Jagtap
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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
- 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
1. Patients with known hypersensitivity to active or inactive ingredients of the IP or other �²-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
8. Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease
9. Female patient with vaginal fungal infections or vulvovaginal infection
10. Current indication for administration of or treatment with antiviral drugs.
11. 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.
12. Patients requiring hospitalization or parenteral antibiotic treatment.
13. Heavy smoking, alcohol abuse or known or suspected drug addiction.
14. Female patients who are pregnant or lactating or planning to become pregnant.
15. 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.
16. 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 11Timepoint: 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 <br/ ><br>- determine the worsening in the clinical signs and symptoms of URTI on Day 5 and Day 11 <br/ ><br>- Global assessment of treatment improvement in the clinical signs and symptoms of URTI on Day 11 <br/ ><br> <br/ ><br>Safety Objective <br/ ><br>Safety and tolerability of the investigational product <br/ ><br>Timepoint: Day 5 and Day 11