← Back to Search

Antibiotic

ALIS + Background Regimen (Azithromycin + Ethambutol) for Nontuberculous Mycobacterial Infections (ARISE Trial)

Phase 3
Waitlist Available
Research Sponsored by Insmed Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 7
Awards & highlights

ARISE Trial Summary

This trial is testing the reliability, validity, and responsiveness of a patient-reported outcome (PRO) endpoint.

Eligible Conditions
  • Nontuberculous Mycobacterial Infections

ARISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Test-Retest Reliability Reported as the Estimate of Score Among Participants Reporting no Change on Fatigue PGI-S Applied to PROMIS F-SF 7a Between Screening and Baseline
Assessment of Test-Retest Reliability Reported as the Estimate of Score Among Participants Reporting no Change on Respiratory PGI-S Applied to QOL-B Respiratory Domain Between Screening and Baseline
Psychometric Cross-Sectional Validation of PRO: Patient-Reported Outcome Measurement Information System - Fatigue-Short Form 7a (PROMIS F-SF 7a)
+4 more
Secondary outcome measures
Change from Baseline in Fatigue Symptom Score at Month 7
Change from Baseline in Respiratory Symptom Score at Month 7
Number of Participants Who Experience an Adverse Event (AEs)
+6 more

ARISE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ALIS + Background Regimen (Azithromycin + Ethambutol)Active Control3 Interventions
Participants will be administered 590 mg of ALIS (amikacin liposome inhalation suspension) once daily. Participants will also be administered the background regimen of azithromycin 250 mg and ethambutol 15 mg/kg tablets orally, once daily.
Group II: ELC + Background Regimen (Azithromycin + Ethambutol)Placebo Group3 Interventions
Participants will be administered ELC (empty liposome control), a matching placebo to ALIS, once daily. Participants will also be administered the background regimen of azithromycin 250 mg and ethambutol 15 mg/kg tablets orally, once daily.

Find a Location

Who is running the clinical trial?

Insmed IncorporatedLead Sponsor
42 Previous Clinical Trials
7,103 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What infections does the ALIS + Azithromycin + Ethambutol cocktail help to clear up?

"ALIS in combination with azithromycin and ethambutol can be used to treat neonatal sepsis, as well as intraabdominal infections where patients have not achieved negative sputum cultures after 6 months of multidrug background regimen therapy."

Answered by AI

Has this combination of ALIS, Azithromycin, and Ethambutol been cleared by the FDA?

"There is a moderate amount of safety data available for the ALIS + Azithromycin + Ethambutol combination, as this is a Phase 3 trial."

Answered by AI

Could you please tell me how many different locations are being used to manage this trial?

"70 clinical trial sites are actively recruiting patients for this study, with locations in cities such as Denver, Celebration and Omaha. To reduce the burden of travel, please select the enrolling location nearest to you."

Answered by AI

Are there any other completed or current research projects that use the combination of ALIS + Azithromycin + Ethambutol?

"The efficacy of ALIS + Azithromycin + Ethambutol was first trialed in 2013 at the Clinique universitaire Saint-Luc. There have been a total of 289 completed clinical trials since then. Currently, there are 72 live studies being conducted; many of these in Denver, Colorado."

Answered by AI

How many subjects can join this clinical research?

"Unfortunately, this study is no longer recruiting patients. Although, if you're seeking other medical trials to participate in, there are presently 820 trials actively looking for patients with mycobacterium abscessus infection and 72 trials for ALIS + Azithromycin + Ethambutol actively enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
2020. "Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677543.
~23 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top