Skip to content

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

Randomized Controlled Trial to assess role of antibiotics in the treatment of upper respiratory tract infection: a Single blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024764
Enrollment
200
Registered
2020-04-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00-J06- Acute upper respiratory infections

Interventions

Intervention1: Antibiotics: Throat swab will be sent on Day 1. Supportive treatment will be started on Day 1. Tablet Levocetrizine 5 mg PO HS for 5-7 days Tablet Levocetrizine 5mg + Montelukast 10 m

Sponsors

Department of ENT All India Institute of Medical Sciences Nagpur
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Symptoms of URTI on day three by using Jackson symptom score . 2. Symptoms of URTI at one week (days six to eight). The illness severity during each URTI episode will be assessed daily using the Wisconsin Upper Respiratory Symptom Survey (WURSS-11 scale) Timepoint: 1. Day 3 2. Day 6-8

Secondary

MeasureTime frame
1. Success: Cure 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. 3. Time of symptom disappearance 4. Incidence of suppurative complications: i) Quinsy; ii) Acute otitis media; iii) Acute sinusitis. Timepoint: 1. Day 14 2. Day 24 3. Day 90

Countries

India

Contacts

Public ContactDr Kiran Kumar Prathipati

All India Institute of Medical Sciences, Nagpur

drkprathipati@aiimsnagpur.edu.in9515657003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026