Evidence map›Paper›PMID 35015255›Full record

ArticleInfectious diseases and therapy2022

Efficacy and Safety of Omadacycline Versus Linezolid in Acute Bacterial Skin and Skin Structure Infections in Persons Who Inject Drugs.

Gregory J Moran, Surya Chitra, Paul C McGovern

Open access · goldAbstract read
In one paragraph

Article in Infectious diseases and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 27% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. 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

3 authors at 2 institutions in 1 country.

Gregory J MoranOlive View-UCLA Medical Center, 14445 Olive View Dr, Sylmar, CA, 91342, USA. gmoran@ucla.edu.
Surya ChitraParatek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Paul C McGovernParatek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Paratek Pharmaceuticals (United States) · USOlive View-UCLA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAcute bacterial skin and skin structure infections (ABSSSI) represent one of the most common reasons for emergency department visits, and are frequent complications of intravenous drug use in persons who inject drugs (PWID). This study examined the efficacy and safety of omadacycline, versus linezolid, in PWID and persons who do not inject drugs, in the Phase 3 Omadacycline in Acute Skin and Skin Structure Infection (OASIS-1, OASIS-2) studies.

methodsEligible participants were aged ≥ 18 years with qualifying skin infections: wound infection, cellulitis, erysipelas, or major abscess. The primary efficacy endpoint was early clinical response (ECR) in the modified intent-to-treat (mITT) population, defined as survival with ≥ 20% reduction in lesion size at 48-72 h after the first dose of omadacycline or linezolid. Key secondary endpoints included investigator-assessed clinical response at the post-treatment evaluation (PTE) in the mITT and clinical per-protocol populations, and clinical response at PTE in the micro-mITT population. Safety was assessed based on adverse events (AEs) and standard clinical laboratory tests. Efficacy endpoints of clinical response at ECR and PTE were analyzed for the mITT and clinically evaluable (CE) PTE populations.

resultsIn total, 1380 patients (822 PWID, 558 non-PWID) were included in this secondary analysis. Wound infections were reported more frequently in the PWID subgroup (72.8%) at baseline; cellulitis or erysipelas (43.9%) and major abscess (37.4%) were the most frequently reported baseline infections in the non-PWID subgroup. Clinical success rates at ECR and PTE in the mITT population, and at PTE in the CE population, were high for patients receiving omadacycline or linezolid. Severe or serious treatment-emergent AEs (TEAEs), and TEAEs leading to discontinuation, were infrequent.

conclusionThis subgroup analysis showed that omadacycline was effective and well tolerated, regardless of PWID status.

Indexed as

AbscessCellulitisDrug useErysipelasInfectious diseaseIntravenous drug useWounds

Identifiers

PMID35015255
PMCPMC8847501
OpenAlexW4205262822

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.