Recruiting

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

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

6 criteria

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 trial?

3 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Amoxicillin – Amoxicillin is typically administered orally in the form of tablets or liquid suspension. It is a well-established antibiotic in medical literature, commonly used to treat bacterial infections. In the context of viral respiratory tract infections, its use is being evaluated to determine if discontinuing it is safe when a viral infection is confirmed. Amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It belongs to the class of penicillin antibiotics.

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.