#1 Clinical Trials Search in Europe

Roxithromycin

Clinical trials are investigating Roxithromycin as part of treatment strategies for hospitalized patients with acute respiratory tract infection. These studies aim to see how Roxithromycin performs in real patient care, mainly looking at survival and recovery outcomes in people with serious breathing-related illness.

Table of Contents

Trial overview

The main clinical trial listed for Roxithromycin is REMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia and other respiratory tract infection care questions.[1]

This study is authorised and is described as an interventional trial, which means researchers assign treatments and then measure patient outcomes.[1]

The condition studied is respiratory tract infection, and the trial focuses on hospitalized patients with acute illness.[1]

Study design and phase

The Roxithromycin trial is in Phase 3, which is a later stage of research that usually looks at how well a treatment works in a larger group of patients.[1]

The study is a platform trial, meaning several treatments are studied in the same research system, and treatment options can be added or compared over time.[1]

The source data list an enrollment of 3471 participants for this trial.[1]

Who the trial is for

The trial is designed for hospitalized patients with acute respiratory tract infection.[1]

The source data do not give a full list of inclusion or exclusion rules, so the exact participation criteria cannot be fully described from the available information.[1]

Because the study looks at different levels of breathing support, it appears to include patients with a range of illness severity, from low-intensity oxygen to advanced support such as invasive ventilation or ECMO.[1]

What is being measured

The main outcome is called Survival and Recovery Trajectory.[1]

This is a composite endpoint, which means it combines more than one result into one main measure.[1]

First, it looks at 90-day all-cause mortality, meaning death from any cause within 90 days after randomization.[1]

Among people who survive to day 90, the study also tracks a daily ordinal scale of illness and recovery up to 28 days.[1]

That scale includes five levels: hospitalized on ECMO or invasive mechanical ventilation, hospitalized on non-invasive ventilation or high-flow oxygen, hospitalized on low-intensity oxygen, hospitalized with no oxygen, and discharged from the index hospitalization.[1]

This means the trial is not only asking whether patients survive, but also how quickly they improve and what level of breathing help they need during recovery.[1]

Roxithromycin in the treatment list

Roxithromycin is listed as one of several study drugs in this platform trial, with an oral dose shown in the source data.[1]

The same trial also includes other treatments such as moxifloxacin, clarithromycin, erythromycin, azithromycin, levofloxacin, ceftriaxone, piperacillin with a beta-lactamase inhibitor, amoxicillin with a beta-lactamase inhibitor, hydrocortisone, dexamethasone, baricitinib, tocilizumab, imatinib, oseltamivir, and baloxavir marboxil.[1]

The source data do not say which patients receive Roxithromycin specifically, only that it is one of the interventions being studied in the platform.[1]

Key patient terms

Randomized means patients are assigned to a treatment by chance, which helps make the comparison fair.[1]

Embedded means the trial is built into routine care settings, so research can happen while patients are being treated in the hospital.[1]

Multifactorial means the study can look at more than one treatment question at the same time.[1]

Adaptive means the trial can change over time based on what the data show, which can help researchers learn more efficiently.[1]

ECMO stands for extracorporeal membrane oxygenation, a machine-based form of advanced breathing and blood support.[1]

Trial ID Phase Condition studied Status Enrollment
NCT02735707 Phase 3 Respiratory tract infection Authorised 3471

FAQ

  • What are clinical trials of Roxithromycin studying? They are studying Roxithromycin as one of several treatment options for hospitalized patients with acute respiratory tract infection. The main goal is to see how it affects survival and recovery over time.
  • Who can take part in these trials? The trial data describe hospitalized patients with acute respiratory tract infection. The exact rules for joining are not fully listed in the source data.
  • What phase is the Roxithromycin trial? The listed Roxithromycin trial is Phase 3. This means it is a later-stage study that looks at how well a treatment works in a larger group of patients.
  • What condition is being studied? The trial focuses on respiratory tract infection, especially in hospitalized patients with acute illness. This includes people who need different levels of breathing support.
  • What results are the researchers measuring? The main result is a combined measure of 90-day death rate and recovery over 28 days. Recovery is tracked by daily breathing support needs and whether the patient is still in the hospital or has been discharged.

Ongoing Clinical Trials on Roxithromycin

  • Study on the Effects of Baricitinib and Drug Combination for Adults with Severe Community-Acquired Pneumonia, Severe Influenza, or Severe and Moderate COVID-19

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium Croatia Czechia Estonia France Germany +7

Glossary

  • Acute respiratory tract infection: A sudden infection that affects the breathing passages or lungs. In this trial, it describes hospitalized patients with serious breathing-related illness.
  • Hospitalized: Being admitted to the hospital for treatment and monitoring.
  • Phase 3: A later stage of clinical research that studies how well a treatment works and continues to collect safety and outcome data in larger groups.
  • Interventional study: A study where researchers assign one or more treatments and then measure the effects.
  • Composite endpoint: A main study result that combines more than one outcome into a single measure.
  • All-cause mortality: Death from any cause, not just one specific disease.
  • Ordinal scale: A rating system that puts patient status into ordered levels, from more severe to less severe.
  • Respiratory support: Help with breathing, ranging from oxygen to more advanced support like mechanical ventilation.
  • Mechanical ventilation: A machine that helps a person breathe when their lungs cannot do enough work on their own.
  • ECMO: A form of advanced life support that moves blood through a machine to add oxygen outside the body.
  • Randomized: Patients are assigned to study treatments by chance, which helps make the comparison fair.

References