Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2019
Omadacycline for Acute Bacterial Skin and Skin Structure Infections.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2019. 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 20 papers.
What it found
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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.
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.
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)
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)
Who cites it
20 citing papers in PubMed.
- What's Behind DOOR Number 2? Recent Applications From Post-Hoc Analyses of Infectious Diseases Randomized Clinical Trials.Open forum infectious diseases · 2026Article
- Inhibitory Effect of Amentoflavone on the Virulence of MRSA by Targeting ClpP.Journal of cellular and molecular medicine · 2025Article
- Intravenous Versus Oral Omadacycline or Linezolid for Acute Bacterial Skin and Skin Infections: A post hoc Analysis of the OASIS Trials.Infectious diseases and therapy · 2024Article
- A Review of Omadacycline for Potential Utility in the Military Health System for the Treatment of Wound Infections.Military medicine · 2024Review
- Real-world effectiveness of omadacycline and impact of unapproved omadacycline prescription claims among adult outpatients with community-acquired bacterial pneumonia or acute bacterial skin and skin structure infections.Journal of managed care & specialty pharmacy · 2023Article
- The Epidemiology of Antibiotic-Related Adverse Events in the Treatment of Diabetic Foot Infections: A Narrative Review of the Literature.Antibiotics (Basel, Switzerland) · 2023Review
- Prediction of postoperative infection in elderly using deep learning-based analysis: an observational cohort study.Aging clinical and experimental research · 2023Observational
- A Comprehensive Overview of the Antibiotics Approved in the Last Two Decades: Retrospects and Prospects.Molecules (Basel, Switzerland) · 2023Review
- Article
- Daptomycin and linezolid for severe methicillin-resistantWorld journal of clinical cases · 2022Article
- Pharmacokinetics, Safety and Pharmacokinetics/Pharmacodynamics Analysis of Omadacycline in Chinese Healthy Subjects.Frontiers in pharmacology · 2022Article
- Omadacycline Efficacy againstComputational intelligence and neuroscience · 2022Article
- Use of oral tetracyclines in the treatment of adult outpatients with skin and skin structure infections: Focus on doxycycline, minocycline, and omadacycline.Pharmacotherapy · 2021Review
- Safety and efficacy of omadacycline by BMI categories and diabetes history in two Phase III randomized studies of patients with acute bacterial skin and skin structure infections.The Journal of antimicrobial chemotherapy · 2021Article
- The Effect of Verapamil, a P-gp Inhibitor, on the Pharmacokinetics, Safety, and Tolerability of Omadacycline in Healthy Adults: A Phase I, Open-Label, Single-Sequence Study.European journal of drug metabolism and pharmacokinetics · 2021Article
- Antimicrobial activity of omadacycline in vitro against bacteria isolated from 2014 to 2017 in China, a multi-center study.BMC microbiology · 2020Article
- New Antibiotics for the Treatment of Acute Bacterial Skin and Soft Tissue Infections in Pediatrics.Pharmaceuticals (Basel, Switzerland) · 2020Review
- Novel Tetracyclines Versus Alternative Antibiotics for Treating Acute Bacterial Infection: A Meta-Analysis of Randomized Controlled Trials.Antibiotics (Basel, Switzerland) · 2019Article
- Omadacycline: A Modernized Tetracycline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Article
- Antimicrobial Activity of Omadacycline Tested against Clinical Bacterial Isolates from Hospitals in Mainland China, Hong Kong, and Taiwan: Results from the SENTRY Antimicrobial Surveillance Program (2013 to 2016).Antimicrobial agents and chemotherapy · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWithin the last decade, methicillin-resistant Staphylococcus aureus (MRSA) has emerged as a frequent cause of purulent skin and soft tissue infections. New therapeutic options are being investigated for these infections.
methodsWe report an integrated analysis of 2 randomized, controlled studies involving omadacycline, a novel aminomethylcycline, and linezolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Omadacycline in Acute Skin and Skin Structure Infections Study 1 (OASIS-1) initiated patients on intravenous omadacycline or linezolid, with the option to transition to an oral formulation after day 3. OASIS-2 was an oral-only study of omadacycline versus linezolid.
resultsIn total, 691 patients received omadacycline and 689 patients received linezolid. Infection types included wound infection in 46.8% of patients, cellulitis/erysipelas in 30.5%, and major abscess in 22.7%. Pathogens were identified in 73.2% of patients. S. aureus was detected in 74.7% and MRSA in 32.4% of patients in whom a pathogen was identified. Omadacycline was noninferior to linezolid using the Food and Drug Administration primary endpoint of early clinical response (86.2% vs 83.9%; difference 2.3, 95% confidence interval -1.5 to 6.2) and using the European Medicines Agency primary endpoint of investigator-assessed clinical response at the posttreatment evaluation. Clinical responses were similar across different infection types and infections caused by different pathogens. Treatment-emergent adverse events, mostly described as mild or moderate, were reported by 51.1% of patients receiving omadacycline and 41.2% of those receiving linezolid.
conclusionsOmadacycline was effective and safe in ABSSSI. CLINICAL TRIALS REGISTRATION: NCT02378480 and NCT02877927.
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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.