1687. Omadacycline in Female Adults With Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study
Abstract
Abstract Background Omadacycline (OMC) is a novel intravenous (IV) and oral aminomethylcycline, approved in the USA for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in adults. We present data from a randomized, adaptive dose–response phase 2 study of OMC in adult females with acute pyelonephritis (AP). Methods Females aged ≥ 18 y with acute uncomplicated pyelonephritis were initially randomized to 1 of 4 once-daily regimens of OMC vs once-daily standard regimen of IV-to-oral levofloxacin (LEV) (total therapy: 7–10 days) (NCT03757234); the randomization algorithm was subsequently adapted by the data monitoring committee (DMC; blinded to the investigators) following interim analyses of efficacy in the microbiological-intent-to-treat (micro-ITT) population (Table 1). Efficacy was assessed for noninferiority according to investigator’s assessment of clinical response (IACR) and microbiological response at post-therapy evaluation (PTE; Day 21) and end of therapy (EOT). Treatment-emergent adverse events (TEAEs) were assessed. Results were reviewed by the DMC. Table 1 Results 201 patients were randomized. Baseline characteristics were similar across groups (Table 2). Among patients with an identified pathogen, the most common species was E. coli. For IACR at both EOT and PTE, no OMC group met noninferiority to LEV (Figure 1), as the lower limit of the 95% CI for the treatment difference exceeded −10% (range −12.4% to −34.8%).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Penicillins for Treatment of Pneumococcal Pneumonia: Does In Vitro Resistance Really Matter?
- Thiophenes—Naturally Occurring Plant Metabolites: Biological Activities and In Silico Evaluation of Their Potential as Cathepsin D Inhibitors
- Inhalable Mannosylated Rifampicin–Curcumin Co-Loaded Nanomicelles with Enhanced In Vitro Antimicrobial Efficacy for an Optimized Pulmonary Tuberculosis Therapy
- Development and validation of microbial bioassay for quantification of Levofloxacin in pharmaceutical preparations
- GC-MS Analysis and Biomedical Therapy of Oil from n-Hexane Fraction of Scutellaria edelbergii Rech. f.: In Vitro, In Vivo, and In Silico Approach
- Propranolol, chlorpromazine and diclofenac restore susceptibility of extensively drug-resistant (XDR)-Acinetobacter baumannii to fluoroquinolones
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.