To Assess Efficacy and Safety of Zedocef Tablet in URTI Patients

Phase 4

Not yet recruiting

Conditions: Disease of upper respiratory tract, unspecified,

Registration Number: CTRI/2020/09/028124

Lead Sponsor: Dr Rajendra Bohra

Brief Summary: This is a prospective single center open label randomized parallel group active controlled clinical study of patients with upper respiratory tract infections. Planned Study Site: One site in India with 60 subjects enrollment period will be approx 6 months screening will be upto 7 days and treatment period will be 10 days primary objective will be To evaluate the efficacy of Cefpodoxime + Clavulanic acid versus Amoxicillin + Clavulanic acid in the clinical signs and symptoms of URTI on Day 11 and primary endpoint will be Proportion of patients with complete cure in the clinical signs and symptoms of URTI at the end of treatment in both treatments groups as assessed by 4-point scale, Safety of the IP as assessed by treatment emergent adverse events (TEAEs) and clinically significant change physical examination details, vital signs and laboratory investigations during 10 days

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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 3.
Women of childbearing potential must be willing to consistently use an appropriate method of contraception 4.
Willingness to give their written informed consent to participate in the study 5.
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 Î²-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 9.
Current symptoms mainly induced by other acute Ear-Nose-Throat (ENT) disease 10.
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.
Patients who have received any antibiotic treatment within 2-3 days prior to enrollment in the study.
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: PMS

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Cefpodoxime Clavulanic acid versus Amoxicillin 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 in both treatment groups	To determine the worsening in the clinical signs and symptoms of URTI on Day 5 and Day 11 in both treatment groups

Trial Locations

Locations (1): Mahatma Gandhi Mission Medical College And Hospital
🇮🇳
Aurangabad, MAHARASHTRA, India
Mahatma Gandhi Mission Medical College And Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Dr Rajendra Bohra
Principal investigator
919225304660
rajbohra@msn.com