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Fluoroquinolone Antibiotic

Omadacycline for Community-acquired Pneumonia (public Trial)

Phase 3

Recruiting

Led By Haihui Huang, PhD

Research Sponsored by Zai Lab (Hong Kong), Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has at least 2 of the following abnormal vital signs: Fever or hypothermia documented by the investigator (temperature > 38.0°C or < 36.0°C), Hypotension with systolic blood pressure (SBP) < 90 mmHg, Heart rate (HR) > 90 beats per minute (bpm), Respiratory rate (RR) > 20 breaths/minute

Has at least 3 of the following symptoms: Cough, Production of purulent sputum, Dyspnea (shortness of breath), Chest pain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

public Trial Summary

This trial studies the effectiveness of omadacycline compared to moxifloxacin in treating Chinese adults with Community Acquired Bacterial Pneumonia.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include digestive issues such as nausea and diarrhea; liver problems signaled by yellow skin or eyes; headache; dizziness; rash; allergic reactions including trouble breathing and swelling around the face.

public Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

public Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall assessment of clinical response rate at post therapy evaluation (PTE) timepoint in the mITT population.

Secondary outcome measures

Clinical response rate at the Early Clinical Response (ECR) assessment (72 to 120 hours after administration of the first dose of test article) in the mITT population.

Clinical response rate at the End of Treatment (EOT) assessment in the mITT and CE population.

Side effects data

From 2016 Phase 3 trial • 655 Patients • NCT02378480

12%

Nausea

Infusion site extravasation

Vomiting

Subcutaneous abscess

Cellulitis

Headache

Alanine aminotransferase increased

Diarrhea

Pruritus

Wound infection

Aspartate aminotransferase increased

Subcutaneous Abscess

Wound Infection

100%

80%

60%

40%

20%

Study treatment Arm

Omadacycline

Linezolid

public Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OmadacyclineExperimental Treatment1 Intervention

Omadacycline IV/PO

Group II: MoxifloxacinActive Control1 Intervention

Moxifloxacin IV/PO

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omadacycline

2016

Completed Phase 3

~2430

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zai Lab (Hong Kong), Ltd.Lead Sponsor

2 Previous Clinical Trials

310 Total Patients Enrolled

Haihui Huang, PhDPrincipal InvestigatorHuashan Hospital

Frequently Asked Questions

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

What potential harms could be associated with Omadacycline use?

"The clinical data collected thus far on omadacycline's safety has been deemed satisfactory, so it was allocated a score of 3."

Answered by AI

How many geographical areas are included in the scope of this research?

"Presently, 4 medical locations are participating by recruiting patients into this study. These sites can be found in Lynwood, Fairfax and Tacoma to name a few. It may be beneficial for you to select the closest site possible so that travel demands remain low if you do choose to enroll."

Answered by AI

Is this research undertaking presently enlisting participants?

"Indeed, the clinicaltrials.gov database confirms that this trial is currently enrolling participants. It was initially published on November 17th 2023 and has been updated recently on December 7th 2023. 100 individuals are expected to be recruited from 4 medical centres across the US of A."

Answered by AI

How many participants have enrolled in this experiment?

"This medical trial requires the recruitment of 100 volunteers that meet certain entry requirements. Zai Lab Site 2016 in Lynwood, California and Zai Lab Site 2023 in Fairfax, Virginia have both been selected as potential study sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP

2023. "A Phase 3b Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline to Moxifloxacin for Treating Adult Subjects With CABP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06162286.

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