In short
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.
Key points
- Clinical trial data for Roxithromycin show one large Phase 3 study in hospitalized patients with acute respiratory tract infection. The trial is part of a broad platform study that tests several treatments in the same research setting. Roxithromycin is one of the treatment options being compared. The main focus is survival and recovery, including death within 90 days and daily illness status over 28 days. The study includes a large number of participants, with enrollment listed as 3471.
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.
This study is authorised and is described as an interventional trial, which means researchers assign treatments and then measure patient outcomes.
The condition studied is respiratory tract infection, and the trial focuses on hospitalized patients with acute illness.
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.
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.
The source data list an enrollment of 3471 participants for this trial.
Who the trial is for
The trial is designed for hospitalized patients with acute respiratory tract infection.
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.
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.
What is being measured
The main outcome is called Survival and Recovery Trajectory.
This is a composite endpoint, which means it combines more than one result into one main measure.
First, it looks at 90-day all-cause mortality, meaning death from any cause within 90 days after randomization.
Among people who survive to day 90, the study also tracks a daily ordinal scale of illness and recovery up to 28 days.
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.
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.
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.
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.
The source data do not say which patients receive Roxithromycin specifically, only that it is one of the interventions being studied in the platform.
Key patient terms
Randomized means patients are assigned to a treatment by chance, which helps make the comparison fair.
Embedded means the trial is built into routine care settings, so research can happen while patients are being treated in the hospital.
Multifactorial means the study can look at more than one treatment question at the same time.
Adaptive means the trial can change over time based on what the data show, which can help researchers learn more efficiently.
ECMO stands for extracorporeal membrane oxygenation, a machine-based form of advanced breathing and blood support.