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

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline Intravenous (IV)/Oral (PO) to Moxifloxacin IV/PO for Treating Adults Subjects With Community-Acquired Bacterial Pneumonia

ClinicalTrials.gov ID

NCT02531438

Acronym / sponsor ID

PTK0796-CABP-1200

Conditions

Bacterial Pneumonia, Community-Acquired Infections

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

774 participants (actual)

Lead sponsor

Paratek Pharmaceuticals IncIndustry (pharma, biotech, devices)

Study start

Nov 2015 (actual)

Primary completion

5 Feb 2017 (actual)

Study completion

10 Mar 2017 (actual)

First posted

24 Aug 2015 (estimated)

Results

Posted 29 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, investigator, outcomes assessor)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Early Clinical Response

   Time frame: Screening; 72 to 120 hours after the first dose of test article

   Early clinical response is defined as clinical success, categorized by survival with improvement of at least 1 level compared to Baseline in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea) with no worsening in the other CABP symptoms. Response was determined programmatically using the investigator's assessment of the CABP symptoms. The severity of the participant's CABP symptoms was evaluated on a 4-point scale (absent, mild, moderate, or severe) based upon the CABP Subject Symptom Severity Guidance Framework for Investigator Assessment. An indeterminate response is defined as one that could not be adequately inferred because the participant was not assessed because they withdrew consent, were lost to follow-up, or other specified reason. Clinical failure is defined as no improvement by at least 1 level in CABP symptoms, worsening of any CABP symptom, alternative antibacterial treatment for CABP, discontinuation due to adverse event, or death.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 37575994Rodriguez GD, Warren N, Yashayev R, Chitra S, Amodio-Groton M, Wright K. Omadacycline in the treatment of community-acquired bacterial pneumonia in patients with comorbidities: a post-hoc analysis of the phase 3 OPTIC trial. Front Med (Lausanne). 2023 Jul 28;10:1225710. doi: 10.3389/fmed.2023.1225710. eCollection 2023.
• Derived from this study: PubMed 35776862Vacalis S, Brunton S, Gindi J. Omadacycline in Skin Infections and Pneumonia: A Review of the Evidence. J Fam Pract. 2022 Jun;71(5 Suppl):S10-S21. doi: 10.12788/jfp.0424.
• Derived from this study: PubMed 33326848Cornely OA, File TM Jr, Garrity-Ryan L, Chitra S, Noble R, McGovern PC. Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild-to-moderate renal impairment. Int J Antimicrob Agents. 2021 Feb;57(2):106263. doi: 10.1016/j.ijantimicag.2020.106263. Epub 2020 Dec 14.
• Derived from this study: PubMed 31367741Ramirez JA, Tzanis E, Curran M, Noble R, Chitra S, Manley A, Kirsch C, McGovern PC. Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice. Clin Infect Dis. 2019 Aug 1;69(Suppl 1):S33-S39. doi: 10.1093/cid/ciz397.
• Derived from this study: PubMed 30726692Stets R, Popescu M, Gonong JR, Mitha I, Nseir W, Madej A, Kirsch C, Das AF, Garrity-Ryan L, Steenbergen JN, Manley A, Eckburg PB, Tzanis E, McGovern PC, Loh E. Omadacycline for Community-Acquired Bacterial Pneumonia. N Engl J Med. 2019 Feb 7;380(6):517-527. doi: 10.1056/NEJMoa1800201.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

140 sites in 25 countries: see every site and its status.