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Study on Stopping Antibiotics in Adults with Viral Respiratory Infections Using Tetracyclines and Other Antibiotics

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What is this study about?

This clinical trial is focused on studying the effects of stopping antibiotic treatment in adults with viral respiratory tract infections. These infections are caused by viruses such as the influenza virus, parainfluenza virus, respiratory syncytial virus (RSV), or human metapneumovirus (hMPV). The study will involve different types of antibiotics, including tetracyclines, beta-lactam antibacterials, fluoroquinolones, lincosamides, aminoglycosides, and trimethoprim and derivatives. The purpose of the study is to determine if it is safe to stop antibiotic treatment in patients who have tested positive for these viruses.

Participants in the study will be adults who are hospitalized and have a moderately severe disease. They will have already started antibiotic treatment as prescribed by their doctor. The study will compare the outcomes of those who continue with their antibiotic treatment to those who stop it. The main goal is to see if stopping antibiotics is just as safe and effective as continuing them. The study will monitor the patients’ health over a period of time to assess their recovery and any need for additional antibiotic treatment.

The study will track several outcomes, including the patients’ recovery within 120 hours after starting the study, survival rates, the length of hospital stays, and any need for further antibiotic treatment. It will also look at the rates of hospital readmissions and any new antibiotic treatments needed up to 30 days after discharge. The study aims to provide valuable information on the safety and effectiveness of discontinuing antibiotics in patients with viral respiratory infections.

1 joining the study

Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

Eligibility includes being 18 years or older, hospitalized with a moderately severe viral respiratory infection, and currently on antibiotic therapy.

2 initial assessment

A nasopharyngeal swab is taken to confirm the presence of specific respiratory viruses such as influenza, parainfluenza, RSV, or hMPV.

The severity of the disease is assessed using a CRB65 score, which evaluates confusion, respiratory rate, blood pressure, and age.

3 randomization

Participants are randomly assigned to either continue or discontinue antibiotic therapy.

The objective is to evaluate the safety and effectiveness of stopping antibiotics in patients with viral infections.

4 treatment phase

If assigned to discontinue antibiotics, monitoring for symptom improvement occurs without additional antibacterial therapy.

If assigned to continue antibiotics, the current treatment regimen is maintained as prescribed by the physician.

5 monitoring and evaluation

The primary endpoint is assessed 120 hours after randomization, focusing on survival and symptom improvement without rescue antibacterial therapy.

Secondary endpoints include in-hospital mortality, mortality at 30 days, duration of hospital stay, and any additional antibiotic therapy required.

6 follow-up

Follow-up includes monitoring for new antibiotic therapy for presumed airway infections and hospital readmissions up to 30 days after discharge.

The study aims to ensure that discontinuing antibiotics does not lead to worse outcomes compared to continuing them.

Who Can Join the Study?

  • The patient must be hospitalized.
  • The patient must be an adult, which means they are 18 years old or older.
  • The patient must have a moderately severe disease. This is measured by a score called CRB65, which should be 2 or less. This score helps doctors understand the severity of the illness.
  • The patient must have a nasopharyngeal swab that tests positive for certain viruses. These viruses include the influenza virus, parainfluenza virus, respiratory syncytial virus (RSV), or human metapneumovirus (hMPV). A nasopharyngeal swab is a test where a sample is taken from the back of the nose and throat.
  • The patient must be currently receiving antibiotic therapy that was started by a doctor in the emergency department.
  • The patient must provide signed informed consent. This means they agree to participate in the study and understand what it involves. This consent must be documented according to specific guidelines and regulations.

Who Cannot Join the Study?

  • Patients who do not have a positive test for respiratory viruses in their airway sample.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway

Other Sites

Site Name City Country Status
Vestfold Hospital Trust Tonsberg Norway
Sørlandet sykehus Kristiansand Kristiansand Norway
Vestre Viken HF Drammen Norway
St. Olavs Hospital HF Trondheim Norway
Sykehuset Oestfold HF Kalnes Graalum Norway
Smvwthrlw Tmpvqebm Hp Skien Norway
Sarmzznip Uhazctorfi Hoyrfquv Hz Stavanger Norway
Agomyymo Ucomtcunmb Hcurqgqn Lorenskog Norway
Hhfrz Bbgkky Hr Bergen Norway

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Norway Norway
Recruiting
01.12.2021

Trial locations

Antibiotic Therapy is being evaluated in this trial to determine if it is safe and effective to stop using it in adult patients who have respiratory virus infections. The study aims to see if stopping antibiotics is just as good as continuing them in terms of safety and effectiveness.

Investigated diseases:

Viral respiratory tract infection – This condition involves an infection of the respiratory tract caused by viruses. It typically affects the nose, throat, and sometimes the lungs, leading to symptoms such as coughing, sneezing, sore throat, and congestion. The infection is usually spread through droplets from coughs or sneezes of an infected person. Symptoms often appear within a few days of exposure and can vary in severity. The body’s immune system usually clears the infection over time, but symptoms can persist for several days to weeks. In some cases, complications such as secondary bacterial infections may occur.

Trial ID:
2023-509286-20-00
NCT ID:
NCT05045612
Trial Phase:
Therapeutic confirmatory (Phase III)

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