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

Trial Summary

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.

What data supports the effectiveness of the drug Omadacycline for treating community-acquired pneumonia?

Research shows that Omadacycline is as effective as Moxifloxacin, a well-known antibiotic, in treating community-acquired pneumonia. Both drugs showed similar success rates in improving patients' conditions in clinical studies. ^{1 2 3 4 5}

Is Omadacycline or Moxifloxacin safe for treating community-acquired pneumonia?

Omadacycline has a generally acceptable safety profile but may cause nausea, vomiting, and slight liver enzyme increases, and has warnings about tooth discoloration and bone growth issues in young children. Moxifloxacin has an excellent safety record with no unexpected side effects reported. ^{5 6 7 8 9}

How does the drug Omadacycline differ from other treatments for community-acquired pneumonia?

Omadacycline is a new tetracycline antibiotic that can evade common bacterial resistance mechanisms, making it effective against a broad range of bacteria. Unlike some other antibiotics, it is derived from minocycline and is specifically designed to overcome resistance, offering a novel option for treating community-acquired pneumonia. ^{1 2 5 6 7}

What is the purpose of this trial?

The primary objective of the study is to show that in Chinese adults with CABP, a course of IV/PO treatment with omadacycline has similar clinical efficacy as the with the comparator antibiotic, IV/PO moxifloxacin. The study is designed as a bridging study, to confirm the results of the pivotal global CABP trial in an ethnically different population of Chinese.

Research Team

Haihui Huang, PhD

Principal Investigator

Huashan Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. Hungary pubmed.ncbi.nlm.nih.gov

[Role of moxifloxacin in the treatment of community-acquired pneumonia]. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). [2021]

4. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intravenous moxifloxacin versus cefoperazone with azithromycin in the treatment of community acquired pneumonia. [2019]

5. Canada pubmed.ncbi.nlm.nih.gov

Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Moxifloxacin (Avelox): a novel fluoroquinolone with a broad spectrum of activity. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

An Integrated Safety Summary of Omadacycline, a Novel Aminomethylcycline Antibiotic. [2020]

9. Canada pubmed.ncbi.nlm.nih.gov

Moxifloxacin (Avelox) for the treatment of bacterial skin infections. [2018]