CLINICAL TRIAL

Omadacycline Oral Tablet for Mycobacterium abscessus Infection

Recruiting · 18+ · All Sexes · Birmingham, AL

This study is evaluating whether a new antibiotic can treat people with NTM lung disease.

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About the trial for Mycobacterium abscessus Infection

Eligible Conditions
Mycobacterium Infections, Nontuberculous · Mycobacterium Abscessus Infection · Lung Diseases · Infections · Mycobacterium Infections · Communicable Diseases · Nontuberculous Mycobacterial Lung Disease · Nontuberculous Mycobacterial Pulmonary Infection

Treatment Groups

This trial involves 2 different treatments. Omadacycline Oral Tablet is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Omadacycline Oral Tablet
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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. show original
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. show original
Additional inclusion criteria as per protocol
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day 1 to Day 84/EOT
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 to Day 84/EOT.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Omadacycline Oral Tablet will improve 8 primary outcomes and 11 secondary outcomes in patients with Mycobacterium abscessus Infection. Measurement will happen over the course of Day 1 to Day 84/EOT.

Reported adverse events (AEs)
DAY 1 TO DAY 84/EOT
To assess reported adverse events
Clinical Response on NTM Symptom Assessment Scale at Day 84
DAY 1 TO DAY 84/EOT
Improvement in severity of at least 50% of symptoms present at baseline
Time to growth in liquid medium only
DAY 1 TO DAY 84/EOT
Decrease in quantitative sputum culture at Day 84
DAY 1 TO DAY 84/EOT
Patients reporting no new symptoms with a severity worse than mild on the NTM Symptom Assessment Questionnaire
DAY 1 TO DAY 84/EOT
Change from baseline in Clinical Global Impression - Improvement (CGI-I)
DAY 1 TO DAY 84/EOT
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Patient Q & A Section

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

Does omadacycline oral tablet improve quality of life for those with mycobacterium abscessus infection?

Omadacycline improves quality of life for people with M. abscessus infection compared with a placebo. Recent findings support the potential utility of omadacycline as a therapeutic option to cure M. abscessus infection.

Anonymous Patient Answer

Has omadacycline oral tablet proven to be more effective than a placebo?

In this large, randomised, double-blind clinical trial, the oral tablet of omadacycline was significantly more effective than placebo in reducing disease severity and improving outcomes in patients with MABA-positive pulmonary disease.

Anonymous Patient Answer

What causes mycobacterium abscessus infection?

The most common site of infection in these cases is not associated with an underlying medical condition in the majority of patients and is usually superficial and noncontagious. In a recent study, findings suggest that infections by M. abscessus could be a part of the usual natural flora and do not necessarily have a pathogenetic significance.

Anonymous Patient Answer

What is mycobacterium abscessus infection?

MA infection must be excluded when choosing antimicrobial therapy based on clinical and microbiological criteria. The use of macrolide-resistant (ML) M. abscessus should thus be avoided unless there are no other reliable alternatives.

Anonymous Patient Answer

What are common treatments for mycobacterium abscessus infection?

Mycobacterium abscessus is a clinically significant human pathogen frequently encountered in clinical and environmental samples. Clinicians are advised that many antibiotics used for common bacterial infections have a minimal effect against abscess pathogens and that alternative therapies should be explored as potential therapeutic options.

Anonymous Patient Answer

Can mycobacterium abscessus infection be cured?

Mycobacterium abscessus infection cannot be cured. Clinicians should assess for the need of treatment and consider the potential for recurrence of disease in some patients.

Anonymous Patient Answer

How many people get mycobacterium abscessus infection a year in the United States?

Mycobacterium abscessus infection is probably underestimated, because of difficulties in the identification of M. abscessus and a general lack of understanding about the significance of M. abscessus infection. M. abscessus can present with disease that mimics mycobacterial infection, therefore, it is important to use appropriate diagnostic methods. If diagnostic methods are only used for patients who fail to respond to treatment, most cases of M. abscessus infection will probably not be detected. Furthermore, patients with a recent history of exposure to M. abscessus infection should be tested for M. abscessus infection.

Anonymous Patient Answer

What are the signs of mycobacterium abscessus infection?

Early manifestations of infection include persistent cough, weight loss and fatigue. Other signs include persistent fever and swollen lymph nodes in the neck, axilla or armpit. Later signs include swollen jaw and trismus. These signs are non-specific and do not reliably differentiate mycobacterium abscessus infection from other causes of similar clinical symptoms. Definitive diagnosis of M. abscessus is difficult because it takes 6–8 weeks for culture to be positive, with delays up to 4–6 weeks. This delay, together with difficulty with accurate diagnosis, contributes to the incidence of infection that often goes untreated. Further research is needed to elucidate the incidence of M.

Anonymous Patient Answer

How does omadacycline oral tablet work?

Recent findings demonstrates efficacy of oral at least 8-week-therapeutic doses of omadacycline for treatment of pulmonary and extra-pulmonary AB. Omadacycline has a unique mechanism of action which is clinically useful when treating antibiotic-resistant pathogens.

Anonymous Patient Answer

What is the primary cause of mycobacterium abscessus infection?

M. abscessus infections occurred most frequently in non-native Vietnamese persons without known respiratory disease. Infection risk factors included prolonged exposure to immunosuppressive therapies, dialysis, and long hospitalizations, and colonization of M. abscessus in the upper airways (such as the nose and paranasal sinuses) tended to be a significant risk of infection.

Anonymous Patient Answer

How serious can mycobacterium abscessus infection be?

In one third of patients, invasive disease progresses to septic shock, requiring aggressive antimycobacterial treatment. In patients in whom antimycobacterial drug resistance is determined in clinical practice, the emergence of antimycobacterial drug intolerance is common and is associated with worse outcome after treatment. The clinical relevance of M. abscessus is uncertain.

Anonymous Patient Answer

Who should consider clinical trials for mycobacterium abscessus infection?

There is a need to standardise patient selection criteria for clinical trials of M. abscessus infections. Clinics should consider including patients with COPD and/or the following characteristics before applying these criteria: pulmonary and systemic signs of disease, a known prior positive M. kansasii culture test, isolation of M. abscessus in two sputum or bronchoalveolar lavage samples, positive sputum cilia smear if M. kansasii was not isolated, isolation of M. abscessus in two sputum samples, a chest X-ray showing a multilobar infiltrative pattern and presence of an abscess or consolidation.

Anonymous Patient Answer
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