Evidence map›Paper›PMID 39461915›Full record

ArticleInfectious diseases and therapy2024

Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials.

George D Rodriguez, Nathan Warren, Roman Yashayev, Surya Chitra, Maria Amodio-Groton, Kelly Wright

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Infectious diseases and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02378480 phase3completednot on this map

A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adults With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

TypeinterventionalSponsorParatek Pharmaceuticals IncRan2015 to 2016Enrolled655ConditionsBacterial Infections, Skin Structures and Soft Tissue InfectionsArmsOmadacycline, Linezolid
NCT02877927 phase3completednot on this map

A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Oral Omadacycline to Oral Linezolid for Treating Adult Subjects With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

TypeinterventionalSponsorParatek Pharmaceuticals IncRan2016 to 2017Enrolled735ConditionsBacterial Infections, Skin Structures and Soft Tissue InfectionsArmsOmadacycline, Linezolid
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

George D RodriguezDivision of Antimicrobial Stewardship, New York-Presbyterian Queens, Flushing, NY, USA.
Nathan WarrenDivision of Antimicrobial Stewardship, New York-Presbyterian Queens, Flushing, NY, USA.
Roman YashayevDivision of Antimicrobial Stewardship, New York-Presbyterian Queens, Flushing, NY, USA.
Surya ChitraParatek Pharmaceuticals, Inc., 1000 First Avenue, Suite 200, King of Prussia, PA, 19406, USA.
Maria Amodio-GrotonParatek Pharmaceuticals, Inc., 1000 First Avenue, Suite 200, King of Prussia, PA, 19406, USA.
Kelly WrightParatek Pharmaceuticals, Inc., 1000 First Avenue, Suite 200, King of Prussia, PA, 19406, USA. Kelly.Wright@paratekpharma.com.ORCID http://orcid.org/0000-0003-2908-2612

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAppropriate oral antibiotic therapy for the treatment of acute bacterial skin and skin structure infections (ABSSSI) is a challenge, as current oral treatment guidelines do not fully cover the most common skin pathogens. Both linezolid and omadacycline are available as intravenous or bioequivalent oral formulations. MATERIALS AND

methodsThis post hoc analysis of the OASIS-1 (ClinicalTrials.gov identifier NCT02378480) and OASIS-2 (ClinicalTrials.gov identifier NCT02877927) phase 3 trials assessed safety and clinical efficacy of intravenous (IV)-start versus oral (PO)-start therapy in patients treated with omadacycline or linezolid for ABSSSI. In OASIS-1, patients were randomized to IV omadacycline or linezolid, with optional switch to oral therapy, while patients in OASIS-2 received oral omadacycline or linezolid. Treatment was provided for 7-14 days in both studies. The primary endpoint was an early clinical response (ECR) at 48 to 72 h, defined as survival and ≥ 20% reduction in lesion size, without rescue antibacterial therapy.

resultsA total of 645 IV-start inpatients and 735 PO-start outpatients were assessed. Median age was 47 years for the IV-start group and 44 years for the PO-start group. Most patients had solely gram-positive infections (97% in each group; ECR [85.2% IV-start and 85.0% PO-start]), and the incidence of treatment-emergent adverse events (AEs) was similar between the groups. The most frequent AEs observed were nausea (11.2% [IV-start] versus 18.9% [PO-start]) and subcutaneous abscess (5.6% [IV-start] versus 1.9% [PO-start]). Discontinuation due to AEs was infrequent in both groups (2% [IV-start] versus 1.2% [PO-start]).

conclusionOral therapy is equally efficacious to IV therapy when omadacycline or linezolid is used to treat ABSSSIs. These data strengthen the evidence for oral omadacycline as a therapeutic option for ABSSSI, particularly for patients who have experienced treatment failure because of the limitations of other therapies.

trial registrationClinicaltrials.gov, NCT02378480 and NCT02877927.

Indexed as

Acute bacterial skin and skin structure infectionsMethicillin-resistant Staphylococcus aureusMRSAOmadacyclineOral antibioticsSkin infections

Identifiers

PMID39461915
PMCPMC11582291

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.