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Omadacycline vs. Moxifloxacin for the Treatment of Community-Acquired Bacterial Pneumonia

NCT ID: NCT04779242

Last Updated: 2025-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2024-03-27

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to moxifloxacin in the treatment of adults with community-acquired bacterial pneumonia.

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Omadacycline vs Moxifloxacin for the Treatment of CABP (EudraCT #2013-004071-13)

NCT02531438

Bacterial Pneumonia Community-Acquired Infections
COMPLETED PHASE3

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

NCT06162286

Community-acquired Bacterial Pneumonia
RECRUITING PHASE3

A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

NCT00717561

Pneumonia
COMPLETED PHASE3

IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis

NCT03757234

Acute Pyelonephritis
COMPLETED PHASE2

Efficacy and Safety Trial to Assess Moxifloxacin in Treating Community-Acquired Pneumonia (CAP) With Aspiration Factors

NCT00752947

Community-Acquired Pneumonia
UNKNOWN PHASE4

Detailed Description

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Conditions

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Community-acquired Pneumonia Bacterial Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Omadacycline

Omadacycline 100 mg IV; Omadacycline 300 mg PO (2 x 150 mg tablets); QD Dosing; 7-10 day duration.

Group Type EXPERIMENTAL

Omadacycline

Intervention Type DRUG

IV for injection, oral tablets

Moxifloxacin

Moxifloxacin 400 mg IV; Moxifloxacin 400 mg tablets; QD Dosing; 7-10 day duration

Group Type ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type DRUG

IV solution, oral tablets

Interventions

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Omadacycline

IV for injection, oral tablets

Intervention Type DRUG

Moxifloxacin

IV solution, oral tablets

Intervention Type DRUG

Other Intervention Names

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NUZYRA Avelox

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects, age 18 or older who have signed the informed consent form
* Must have a qualifying community-acquired bacterial pneumonia
* Subjects must not be pregnant or nursing at the time of enrollment
* Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria

* Known or suspected hospital-acquired pneumonia
* Confirmed or suspected SARS-CoV-2 infection
* Evidence of significant immunological disease
* Has a life expectancy of less than or equal to 3 months or any concomitant condition that is likely to interfere with evaluation of the response of the infection under study, determination of AEs, or completion of the expected course of treatment
* Has a history of contraindications, hypersensitivity, or allergic reaction to any tetracycline or fluoroquinolone antibiotic
* Has received an investigational drug within the past 30 days
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paratek Pharmaceuticals Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Manley

Role: STUDY_DIRECTOR

Paratek Pharmaceuticals Inc

Locations

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Site 210

Gabrovo, , Bulgaria

Site Status

Site 213

Lom, , Bulgaria

Site Status

Site 208

Pernik, , Bulgaria

Site Status

Site 201

Pleven, , Bulgaria

Site Status

Site 206

Rousse, , Bulgaria

Site Status

Site 207

Sliven, , Bulgaria

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Site 202

Sofia, , Bulgaria

Site Status

Site 204

Sofia, , Bulgaria

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Site 205

Sofia, , Bulgaria

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Site 209

Sofia, , Bulgaria

Site Status

Site 212

Vidin, , Bulgaria

Site Status

Site 211

Vratsa, , Bulgaria

Site Status

Site 302

Split, , Croatia

Site Status

Site 301

Zagreb, , Croatia

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Site 303

Zagreb, , Croatia

Site Status

Site 304

Zagreb, , Croatia

Site Status

Site 401

Tbilisi, , Georgia

Site Status

Site 402

Tbilisi, , Georgia

Site Status

Site 403

Tbilisi, , Georgia

Site Status

Site 404

Tbilisi, , Georgia

Site Status

Site 405

Tbilisi, , Georgia

Site Status

Site 406

Tbilisi, , Georgia

Site Status

Site 407

Tbilisi, , Georgia

Site Status

Site 802

Balassagyarmat, , Hungary

Site Status

Site 801

Budapest, , Hungary

Site Status

Site 803

Debrecen, , Hungary

Site Status

Site 804

Kistarcsa, , Hungary

Site Status

Site 805

Törökbálint, , Hungary

Site Status

Site 901

Chrzanów, , Poland

Site Status

Site 904

Krakow, , Poland

Site Status

Site 902

Oświęcim, , Poland

Site Status

Site 903

Łęczna, , Poland

Site Status

Site 506

Moscow, , Russia

Site Status

Site 510

Moscow, , Russia

Site Status

Site 507

Saint Petersburg, , Russia

Site Status

Site 508

Saint Petersburg, , Russia

Site Status

Site 509

Saint Petersburg, , Russia

Site Status

Site 703

Belgrade, , Serbia

Site Status

Site 704

Belgrade, , Serbia

Site Status

Site 705

Belgrade, , Serbia

Site Status

Site 707

Belgrade, , Serbia

Site Status

Site708

Belgrade, , Serbia

Site Status

Site 706

Kamenitz, , Serbia

Site Status

Site 701

Kragujevac, , Serbia

Site Status

Site 702

Niš, , Serbia

Site Status

Site 606

Dnipro, , Ukraine

Site Status

Site 602

Kharkiv, , Ukraine

Site Status

Site 604

Kharkiv, , Ukraine

Site Status

Site 611

Kharkiv, , Ukraine

Site Status

Site 603

Kyiv, , Ukraine

Site Status

Site 605

Kyiv, , Ukraine

Site Status

Site 607

Kyiv, , Ukraine

Site Status

Site 609

Kyiv, , Ukraine

Site Status

Site 608

Zaporizhia, , Ukraine

Site Status

Site 610

Zaporizhia, , Ukraine

Site Status

Countries

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Bulgaria Croatia Georgia Hungary Poland Russia Serbia Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PTK0796-CABP-19302

Identifier Type: -

Identifier Source: org_study_id

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