Trial reportAntimicrobial agents and chemotherapy2019
Pharmacokinetics, Safety, and Clinical Outcomes of Omadacycline in Women with Cystitis: Results from a Phase 1b Study.
Trial report in Antimicrobial agents and chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 36 citations in OpenAlex.
- Omadacycline for community-acquired infections: A systematic review and single-arm meta-analysisBiomedica : revista del Instituto Nacional de Salud · 2026Pooled it
- Efficacy and safety of omadacycline for treating complicated skin and soft tissue infections: a meta-analysis of randomized controlled trials.BMC infectious diseases · 2024Pooled it
- Omadacycline andThe Annals of pharmacotherapy · 2023Pooled it
- Assessment of pharmacokinetics-pharmacodynamics to support omadacycline dosing regimens for the treatment of patients with acute bacterial skin and skin structure infections.Antimicrobial agents and chemotherapy · 2024Trial
- Pharmacokinetic-Pharmacodynamic Target Attainment Analyses Evaluating Omadacycline Dosing Regimens for the Treatment of Patients with Community-Acquired Bacterial Pneumonia Arising from Streptococcus pneumoniae and Haemophilus influenzae.Antimicrobial agents and chemotherapy · 2023Trial
- Omadacycline Pharmacokinetics: Characteristics, Contributing Factors, and Clinical Significance.Drugs in R&D · 2025Review
- Efficacy and safety of omadacycline for the treatment of infectious diseases: a real-world, retrospective study of 2587 patients.Frontiers in pharmacology · 2025Article
- A real-world pharmacovigilance analysis of omadacycline in FDA adverse event reporting system (FAERS) database.Frontiers in pharmacology · 2025Article
- Omadacycline for Diverse Infections in China: A Real-World Analysis of Efficacy and Safety.Infectious diseases and therapy · 2024Article
- Definitions of Urinary Tract Infection in Current Research: A Systematic Review.Open forum infectious diseases · 2023Review
- Omadacycline Is Highly ActiveMicrobiology spectrum · 2022Article
- Review
- Pharmacokinetics, Safety and Pharmacokinetics/Pharmacodynamics Analysis of Omadacycline in Chinese Healthy Subjects.Frontiers in pharmacology · 2022Article
- The Development of Third-Generation Tetracycline Antibiotics and New Perspectives.Pharmaceutics · 2021Review
- Use of Oral Tetracyclines in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia: A Literature Review on the Often-Overlooked Antibiotic Class.Antibiotics (Basel, Switzerland) · 2020Review
- In vitro activity of omadacycline and levofloxacin against Escherichia coli, Klebsiella pneumoniae and Staphylococcus saprophyticus in human urine supplemented with calcium and magnesium.The Journal of antimicrobial chemotherapy · 2020Article
- Population Pharmacokinetic Analyses for Omadacycline Using Phase 1 and 3 Data.Antimicrobial agents and chemotherapy · 2020Article
- Omadacycline: A Review of the Clinical Pharmacokinetics and Pharmacodynamics.Clinical pharmacokinetics · 2020Review
- Review
- Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines.Pharmaceuticals (Basel, Switzerland) · 2019Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Omadacycline, an aminomethylcycline antibiotic, is approved as once-daily intravenous (i.v.) and oral (p.o.) monotherapy for acute bacterial skin and skin structure infections and for community-acquired bacterial pneumonia, and it is under development for treatment of urinary tract infection (UTI). This is a phase 1b, randomized, open-label study of omadacycline in women with cystitis (defined as UTI symptoms and a positive urine leukocyte esterase test). Patients received omadacycline for 5 days (group 1: 200 mg intravenously on day 1, then 300 mg orally every 24 h [q24h]; group 2: 300 mg orally every 12 h [q12h] on day 1, then 300 mg orally q24h; group 3: 450 mg orally q12h on day 1, then 450 mg orally q24h). Blood and urine samples were collected over 5 days. Investigator-assessed clinical response was determined at end of treatment (EOT; day 6) and posttreatment evaluation (PTE; 5 to 9 days after last dosing). A total of 31 women were treated. At steady state (day 5), the range of mean omadacycline urine concentrations over 24 h across the groups was 17.94 to 48.12 μg/ml. The most common treatment-emergent adverse events were gastrointestinal (including nausea [60% to 73%] and vomiting [20% to 40%]) and were generally mild and transient. Investigator-determined clinical success was observed in 94% and 84% of patients at EOT and PTE, respectively, with similar results across groups. A favorable microbiological response at PTE was observed in 78% of patients who had a baseline pathogen. Omadacycline is partially excreted in urine and appears to be safe and well tolerated. These preliminary results indicate that omadacycline warrants further evaluation in larger controlled UTI studies.
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