Trial to assess role of antibiotics in the treatment of upper respiratory tract infectio
- 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
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
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
Name Time Method 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
Name Time Method 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