Recruiting PHASE4 Infectious Disease

New treatment option for Infectious Disease

Official title Antibiotic Therapy in Viral Airway Infections

ClinicalTrials.gov ID: NCT05045612

What this study is testing

What it's testing
Antimicrobial resistance is one of the most urgent health threats of our time, and Norwegian hospitals were required to reduce the use of broad-spectrum antibiotics with 30% by the end of 2020. In the current proposal, the investigators aim to assess the efficacy and safety of early discontinuation of antibiotic therapy in adult patients infected with respiratory viruses.
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Hospitalized
  • Adults 18 year or older
  • Moderately severe disease (CRB65 ≤ 2 at time of inclusion)
  • Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)
  • On antibiotic therapy as instituted by the receiving physician from the emergency department

You likely can't join if

  • Requiring ICU admission at screening
  • Requiring high-flow oxygen therapy or non-invasive ventilation at screening
  • Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial...
  • Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression...
  • SARS-CoV-2 positive
  • Bacteremia
See the full eligibility criteria
Who can join
  • Hospitalized
  • Adults 18 year or older
  • Moderately severe disease (CRB65 ≤ 2 at time of inclusion)
  • Nasopharyngeal swab positive for influenza virus, parainfluenza virus, respiratory syncytial virus (RSV) or human metapneumovirus (hMPV)
  • On antibiotic therapy as instituted by the receiving physician from the emergency department
  • Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations.
What rules you out
  • Requiring ICU admission at screening
  • Requiring high-flow oxygen therapy or non-invasive ventilation at screening
  • Signs of severe pneumonia (abscesses, massive pleural effusion, a well-defined lobar infiltrate on chest X-ray strongly suggestive of bacterial etiology)
  • Not immunocompetent (i.e. on active chemotherapy, corticosteroid therapy equaling ≥ 20 mg prednisolone daily for ≥ 4 weeks, chronic immunosuppression due to solid organ transplant)
  • SARS-CoV-2 positive
  • Bacteremia
  • Urine antigen test positive for legionella
  • Any other infection necessitating antibiotic treatment
  • Antibiotic use for assumed airway infection within the last 24 hours before admission to hospital
  • Time from initiation of antibiotic therapy to screening \>48 hours

The study team makes the final eligibility decision.

Where it's taking place

  • Bergen, Norway
  • Drammen, Norway
  • Gjettum, Norway
  • Grålum, Norway
  • Kristiansand, Norway
  • Lørenskog, Norway
  • Oslo, Norway
  • Skien, Norway
  • Stavanger, Norway
  • Tromsø, Norway
  • Trondheim, Norway
  • Tønsberg, Norway

Compensation & support

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Bergen, Norway; Drammen, Norway; Gjettum, Norway; Grålum, Norway; Kristiansand, Norway; Lørenskog, Norway and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.