Omadacycline vs Moxifloxacin for Community-acquired Pneumonia

(public Trial)

Recruiting at 41 trial locations

Overseen By Harriet Li

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Zai Lab (Hong Kong), Ltd.

Disqualifiers: Antibacterial treatment, Resistant pathogens, Empyema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two antibiotics, omadacycline and moxifloxacin, to determine their effectiveness in treating community-acquired pneumonia (a lung infection) in Chinese adults. Researchers aim to confirm if omadacycline matches the effectiveness of moxifloxacin, which is already used for this condition. Suitable candidates for this trial include those experiencing at least three symptoms, such as persistent cough, breathing trouble, or chest pain, along with abnormal vital signs like fever or a fast heart rate. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been on antibacterial treatment for more than 24 hours within the 72-hour window before joining the trial, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that omadacycline is generally well-tolerated by people with community-acquired bacterial pneumonia (CABP). Serious side effects occurred at a similar rate for both omadacycline and moxifloxacin, with about 6% of patients experiencing them. This indicates that the safety of omadacycline is comparable to moxifloxacin, a commonly used antibiotic.

Omadacycline already has approval for treating CABP, offering some reassurance about its safety. For those considering joining a trial, these findings suggest that the treatment is likely safe for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pneumonia?

Omadacycline is unique because it offers a new approach to treating community-acquired pneumonia. Unlike many existing antibiotics, which often target specific bacterial processes, omadacycline is a broad-spectrum tetracycline antibiotic that can be taken both intravenously and orally, offering flexible administration options. This flexibility is particularly beneficial for patients who may need to switch from hospital to home care. Researchers are excited about omadacycline because it has shown effectiveness against resistant strains of bacteria, which is a growing concern with current treatments like moxifloxacin. Additionally, its broad-spectrum activity could make it a valuable option for treating a wide range of bacterial infections.

What evidence suggests that this trial's treatments could be effective for community-acquired pneumonia?

This trial will compare the effectiveness of Omadacycline and Moxifloxacin for treating community-acquired bacterial pneumonia (CABP). Research has shown that Omadacycline, which participants in this trial may receive, is a safe and effective treatment for moderate to severe CABP. One study found that Omadacycline had a success rate of 81%, closely matching the 83% success rate of Moxifloxacin, the comparator treatment in this trial. This indicates that Omadacycline works almost as well as Moxifloxacin. Another study found that patients who took Omadacycline had fewer visits to the emergency room or hospital within 30 days compared to those who did not take it. Overall, Omadacycline has proven to be a reliable option for treating CABP. ^{5 6 7 8 9}

Who Is on the Research Team?

Haihui Huang, PhD

Principal Investigator

Huashan Hospital

Are You a Good Fit for This Trial?

Adults in China with community-acquired bacterial pneumonia (CABP) who have a fever or low body temperature, low blood pressure, fast heart rate, or rapid breathing. They must also have symptoms like coughing, sputum production, shortness of breath, and chest pain. People can't join if they've had antibiotics within 72 hours before the trial or if their CABP is caused by certain resistant pathogens.

Inclusion Criteria

I have at least two of these: fever or very low temperature, low blood pressure, fast heart rate, or rapid breathing.

Written and signed informed consent obtained before any protocol specific assessment is performed

I have at least 3 symptoms: cough, chest pain, shortness of breath, or mucus production.

Exclusion Criteria

I have taken antibiotics for more than a day within the last 3 days.

I might have a lung infection resistant to some antibiotics.

I have or might have an infection in the space around my lungs or a lung abscess.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Omadacycline or Moxifloxacin IV/PO for treating CABP

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moxifloxacin
• Omadacycline

Trial Overview The study compares Omadacycline to Moxifloxacin for treating CABP in Chinese adults. Participants will receive either IV/PO Omadacycline or IV/PO Moxifloxacin to see if Omadacycline's effectiveness is similar to that of Moxifloxacin.

How Is the Trial Designed?

Group I: Omadacycline Experimental Treatment 1 Intervention

Omadacycline IV/PO

Group II: Moxifloxacin Active Control 1 Intervention

Moxifloxacin IV/PO

Moxifloxacin is already approved in United States, European Union for the following indications:

Approved in United States as Moxifloxacin for:

• Acute bacterial sinusitis
• Acute bacterial exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated skin and skin structure infections
• Complicated intra-abdominal infections

Approved in European Union as Moxifloxacin for:

• Acute bacterial sinusitis
• Acute exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated skin and soft tissue infections
• Complicated intra-abdominal infections

Who Is Running the Clinical Trial?

Zai Lab (Hong Kong), Ltd.

Lead Sponsor

Trials

4

Recruited

430+

Published Research Related to This Trial

Moxifloxacin is a broad-spectrum antibiotic that is effective against both Gram-positive and Gram-negative bacteria, making it a versatile treatment option.

The US FDA has approved moxifloxacin for the treatment of bacterial skin infections, highlighting its safety and efficacy in addressing this specific type of infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moxifloxacin (Avelox) for the treatment of bacterial skin infections. Parish, LC., Witkowski, JA., Routh, HB.[2018]

Moxifloxacin is a broad-spectrum antibiotic effective against various respiratory pathogens, including those that are typically resistant to older fluoroquinolones, making it a strong option for treating community-acquired respiratory infections.

The drug has a favorable safety profile with no unexpected adverse events reported, and its pharmacologic properties allow for convenient once-daily dosing without significant adjustments needed for patients with renal or hepatic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moxifloxacin (Avelox): a novel fluoroquinolone with a broad spectrum of activity. Caeiro, JP., Iannini, PB.[2019]

Omadacycline, approved by the FDA in 2018, is an effective new antibiotic for treating community-acquired pneumonia and acute bacterial skin infections, showing promise against a wide range of bacteria.

This drug is a semisynthetic derivative of minocycline that can overcome common bacterial resistance mechanisms, making it a valuable option in the fight against resistant infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines. Durães, F., Sousa, E.[2020]

Omadacycline is a semisynthetic tetracycline antibiotic that has shown an acceptable safety profile in treating acute bacterial skin infections and community-acquired pneumonia, with common side effects including transient nausea and low increases in liver enzymes.

While omadacycline is generally safe, it carries specific warnings such as potential tooth discoloration and risks to bone growth in young children, and a slight increase in mortality was noted compared to moxifloxacin in pneumonia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic. Opal, S., File, TM., van der Poll, T., et al.[2020]

In a study of patients treated with moxifloxacin for community-acquired pneumonia, four cases showed ineffective treatment, leading to serious complications, including ICU admissions and one death.

The findings suggest that moxifloxacin is not more effective than standard antibiotic therapies for this condition, and it should be reserved for patients who are allergic to or unresponsive to other antibiotics, particularly in cases involving penicillin-resistant bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of moxifloxacin in the treatment of community-acquired pneumonia]. Máthé, A., Tóth, K., Kovács, G.[2018]

In the phase III OPTIC study involving 660 patients with community-acquired bacterial pneumonia, omadacycline demonstrated non-inferiority to moxifloxacin in clinical response at post-treatment evaluation, with success rates of 88.4% for omadacycline compared to 85.2% for moxifloxacin.

Both antibiotics showed similar efficacy against various pathogens and across different patient subgroups, indicating that omadacycline is a viable alternative to moxifloxacin for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia. Torres, A., Garrity-Ryan, L., Kirsch, C., et al.[2021]

In the phase 3 OPTIC study involving 774 patients with community-acquired bacterial pneumonia, omadacycline was found to be noninferior to moxifloxacin in terms of early clinical response and post-treatment evaluation, indicating its effectiveness as a treatment option.

The efficacy of omadacycline was consistent across various disease severity levels and characteristics, although moxifloxacin showed better clinical success in patients with bacteremia, suggesting that while omadacycline is a viable alternative, moxifloxacin may be preferred in specific cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Omadacycline Versus Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia by Disease Severity: Results From the OPTIC Study. Ramirez, J., Deck, DH., Eckburg, PB., et al.[2022]

In a study of 40 patients with community-acquired pneumonia, intravenous moxifloxacin showed clinical efficacy rates similar to the standard treatment of cefoperazone and azithromycin, with 90% efficacy for moxifloxacin compared to 95% for the control group.

Both moxifloxacin and the standard treatment were well-tolerated, with comparable rates of drug-related adverse events, suggesting that moxifloxacin can be a reliable alternative for treating pneumonia, especially in the context of rising antibiotic resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intravenous moxifloxacin versus cefoperazone with azithromycin in the treatment of community acquired pneumonia. Xu, S., Xiong, S., Xu, Y., et al.[2019]

In a study of 2733 hospitalized patients with community-acquired pneumonia (CAP) treated with moxifloxacin, 96.7% showed improvement and 93.2% were cured, indicating high efficacy of the antibiotic.

The safety profile of moxifloxacin was consistent with previous knowledge, with only 4.9% of patients experiencing treatment-emergent adverse events, and no deaths reported among those with serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). Kuzman, I., Bezlepko, A., Kondova Topuzovska, I., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10398854/

Real-world effectiveness of omadacycline and impact ... Patients with unfilled omadacycline prescriptions were more likely to have 30-day ED/hospital visits relative to patients with filled prescriptions.

2. journals.asm.org journals.asm.org/doi/10.1128/aac.01087-24

New Perspectives on Antimicrobial Agents - ASM Journals Results demonstrated the noninferiority of omadacycline, with early clinical response (ECR) rates of 81% vs 83% for moxifloxacin and post- ...

3. respiratory-therapy.com respiratory-therapy.com/products-treatment/pharmaceuticals/us-pharmaceuticals/post-marketing-study-confirms-efficacy-omadacycline-pneumonia/

Study Confirms Efficacy of Omadacycline for Pneumonia The study results confirm that omadacycline is a safe and effective treatment for moderate to severe community-acquired bacterial pneumonia.

4. nuzyra.com nuzyra.com/hcp/cabp-patient-case-1/

CABP Patient Case Study - NUZYRA® (omadacycline) Review case study of NUZYRA® and how it was proven effective in the treatment of CABP. Please see Important Safety Information and Full Prescribing ...

5. ir.zailaboratory.com ir.zailaboratory.com/zh-hant/news-releases/news-release-details/paratek-pharmaceuticals-announces-positive-top-line-efficacy-and/

Paratek Pharmaceuticals Announces Positive Top-line ... The global, Phase 3 clinical study known as OPTIC-2 (Omadacycline for Pneumonia Treatment in the Community-2), compared the efficacy and safety ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11823662/

Omadacycline for community-acquired pneumonia, skin ... Post-treatment success was 86.0% for omadacycline and 87.7% for moxifloxacin, consistent across patient risk classes and pathogen types.

7. firstwordpharma.com firstwordpharma.com/story/6323887

Paratek Pharmaceuticals to Present New Data on NUZYRA ... NUZYRA (omadacycline) is a once-daily oral and intravenous antibiotic indicated for adults with community-acquired bacterial pneumonia (CABP) ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa1800201

Omadacycline for Community-Acquired Bacterial Pneumonia Serious adverse events that emerged after treatment initiation occurred with similar incidence in the two groups (6.0% in the omadacycline ...

9. infectiousdiseaseadvisor.com infectiousdiseaseadvisor.com/news/bacterial-cap-omadacycline-moxifloxacin-similarly-boost-qol/

In Bacterial CAP, Omadacycline and Moxifloxacin Similarly ... Patients with community-acquired bacterial pneumonia (CABP) receiving omadacycline vs moxifloxacin had similar improvement in HRQoL.