Omadacycline Oral Tablet for Mycobacterium abscessus Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mycobacterium abscessus Infection+7 More
Omadacycline Oral Tablet - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if omadacycline is better than placebo at treating NTM pulmonary disease caused by MABc.

Eligible Conditions
  • Mycobacterium abscessus Infection
  • Nontuberculous Mycobacteria
  • Nontuberculous Mycobacterial Pulmonary Infection
  • Mycobacterium Abscessus Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mycobacterium abscessus Infection

Study Objectives

8 Primary · 11 Secondary · Reporting Duration: Day 1 to Day 84/EOT

Day 84
Change from baseline in Clinical Global Impression - Improvement (CGI-I)
Change from baseline in Clinical Global Impression - Severity of Illness (CGI-S)
Change from baseline in Patient Clinical Impression of Change (PGI-C)
Change from baseline in Patient Clinical Impression of Severity (PGI-S)
Change from baseline in Patient-Reported Outcomes Measurement Information System Short Form v1.0 - Fatigue 7a Daily (PROMIS-7a)
Change from baseline in global score and individual domain scores of the St. George Respiratory Questionnaire (SGRQ)
Change from baseline in the total score of the Quality of Life - Bronchiectasis (QOL-B) questionnaire
Changes from baseline in electrocardiogram (ECG)
Changes from baseline in laboratory tests
Changes from baseline in vital signs
Clinical Response on NTM Symptom Assessment Scale at Day 84
Clinically significant (CS) electrocardiogram (ECG) findings
Clinically significant (CS) vital signs
Clinically significant (CS), outside normal range laboratory tests
Decrease in quantitative sputum culture at Day 84
Patients reporting no new symptoms with a severity worse than mild on the NTM Symptom Assessment Questionnaire
Reported adverse events (AEs)
Time to first negative sputum culture
Time to growth in liquid medium only

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Mycobacterium abscessus Infection

Trial Design

2 Treatment Groups

Omadacycline 300 mg PO
1 of 2
Placebo PO
1 of 2
Experimental Treatment
Non-Treatment Group

75 Total Participants · 2 Treatment Groups

Primary Treatment: Omadacycline Oral Tablet · Has Placebo Group · Phase 2

Omadacycline 300 mg PO
Drug
Experimental Group · 1 Intervention: Omadacycline Oral Tablet · Intervention Types: Drug
Placebo PO
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 84/eot

Who is running the clinical trial?

Paratek Pharmaceuticals IncLead Sponsor
14 Previous Clinical Trials
3,729 Total Patients Enrolled
Gail Berman, MDStudy ChairParatek Pharmaceuticals Inc

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The individual has at least 2 of the following symptoms of an NTM infection present at screening and baseline: chronic cough, coughing up blood (hemoptysis), wheezing, chest pain, frequent throat clearing, phlegm or sputum production, shortness of breath, fatigue, fever, night sweats, poor appetite, and/or weight loss.
At least 1 positive pulmonary culture for MABc in the last 6 months.
The investigator believes that the subject does not need guideline-directed antibiotic therapy for treatment of MABc within the next 3 months and that delaying treatment for the subject to participate in a placebo-controlled clinical trial is reasonable and clinically acceptable.
been confirmed? Yes, a diagnosis of Nontuberculous Mycobacterial pulmonary disease caused by MABc has been confirmed.
for inclusion in study In the past three months, a CT scan of the chest was taken of someone who may have been infected with MABc.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.