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Trial to assess role of antibiotics in the treatment of upper respiratory tract infectio

Not Applicable
Conditions
Health Condition 1: J00-J06- Acute upper respiratory infections
Registration Number
CTRI/2020/04/024764
Lead Sponsor
Department of ENT All India Institute of Medical Sciences Nagpur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.The patient presenting with symptoms of URTI:

Runny nose

Nasal congestion

Headache

Low-grade fever

Facial pressure

Sneezing

The patient presenting with cough, with or without sputum, lasting for less than 2 weeks

History of fever

Cervical lymphadenopathy

Sore throat

2.The patient whose throat swab shows positive culture for pathogenic bacteria

3.Patients willing to participate in the study and ready for follow-up.

4.Patients who are in agreement with the terms of the informed consent

Exclusion Criteria

1)The patient who have taken antibiotic treatment for the present illness

2)Patients less than 18 years of age

3)Patients more than 60 years of age

4)The patient presenting with complication

5)The patient with other generalized illness

6) Known hypersensitivity to the contents of the drugs

7)Pregnancy or Lactation

8)Use of any antibiotic drug within the last 15 days

9)Other conditions considered by the investigator as reasonable for non-eligibility

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Symptoms of URTI on day three by using Jackson symptom score . <br/ ><br>2. Symptoms of URTI at one week (days six to eight). <br/ ><br> The illness severity during each URTI episode will be assessed daily using the Wisconsin Upper Respiratory Symptom Survey (WURSS-11 scale) <br/ ><br>Timepoint: 1. Day 3 <br/ ><br>2. Day 6-8
Secondary Outcome Measures
NameTimeMethod
1. Success: Cure <br/ ><br>2. Failure: No change in, or worsening of baseline signs and symptoms requiring modification of treatment, i.e. addition of or switch to another systemic antibacterial therapy or drug. Unknown or missing values were considered as failure. <br/ ><br>3. Time of symptom disappearance <br/ ><br>4. Incidence of suppurative complications: <br/ ><br>i) Quinsy; <br/ ><br>ii) Acute otitis media; <br/ ><br>iii) Acute sinusitis. <br/ ><br>Timepoint: 1. Day 14 <br/ ><br>2. Day 24 <br/ ><br>3. Day 90
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