Paul B. Eckburg
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View article: Evaluation of Factors Predictive of Efficacy Among Patients With Complicated Urinary Tract Infection and/or Acute Pyelonephritis
Evaluation of Factors Predictive of Efficacy Among Patients With Complicated Urinary Tract Infection and/or Acute Pyelonephritis Open
Background Antibiotic treatment for complicated urinary tract infections (cUTI)/acute pyelonephritis (AP) is often followed by recurrent bacteriuria in the absence of clinical symptoms. To understand factors predictive of clinical and micr…
View article: Effect of tebipenem pivoxil hydrobromide on the normal gut microbiota of a healthy adult population in Sweden: a randomised controlled trial
Effect of tebipenem pivoxil hydrobromide on the normal gut microbiota of a healthy adult population in Sweden: a randomised controlled trial Open
Spero Therapeutics.
View article: 2144. A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function
2144. A Phase 1, Multicenter, Open-Label, Parallel-Group Study to Assess the Safety and Pharmacokinetics (PK) of Oral Epetraborole Tablets in Adult Subjects with Varying Degrees of Renal Function Open
Background Epetraborole (EBO), an orally available bacterial leucyl transfer RNA synthetase inhibitor with potent activity against nontuberculous mycobacteria, is in clinical development for treatment-refractory MAC lung disease. The objec…
View article: 2556. A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics (PK), Safety, and Tolerability of Epetraborole Tablets and the Impact of Alcohol Dehydrogenase (ADH) Genotype on the PK of Epetraborole and Metabolite M3 in Healthy Japanese Adult Subjects
2556. A Phase 1, Open-Label, Single Dose Study to Evaluate the Pharmacokinetics (PK), Safety, and Tolerability of Epetraborole Tablets and the Impact of Alcohol Dehydrogenase (ADH) Genotype on the PK of Epetraborole and Metabolite M3 in Healthy Japanese Adult Subjects Open
Background Epetraborole (EBO), an orally available bacterial leucyl transfer RNA synthetase inhibitor with potent activity against nontuberculous mycobacteria, is under clinical development for treatment-refractory MAC lung disease. Noncli…
View article: Impact of antibiotic pharmacokinetics in urine on recurrent bacteriuria following treatment of complicated urinary tract infections
Impact of antibiotic pharmacokinetics in urine on recurrent bacteriuria following treatment of complicated urinary tract infections Open
The clinical relevance of bacteriuria following antibiotic treatment of complicated urinary tract infections in clinical trials remains controversial. We evaluated the impact of urine pharmacokinetics on the timing of recurrent bacteriuria…
View article: 222. Clinical and microbiological outcomes for Enterobacterales uropathogens in the Phase 3 ADAPT-PO Study of oral tebipenem pivoxil hydrobromide
222. Clinical and microbiological outcomes for Enterobacterales uropathogens in the Phase 3 ADAPT-PO Study of oral tebipenem pivoxil hydrobromide Open
Background Enterobacterales (ENT) are frequently implicated in complicated urinary tract infection, including acute pyelonephritis (cUTI/AP), with Escherichia coli (EC) being the most prevalent. Extended-spectrum β-lactamase (ESBL)-produci…
View article: 2236. Effectiveness of TBP-PI-HBr in Patients with Instrumentation, Anatomic or Functional Abnormalities: Secondary Analysis from ADAPT-PO
2236. Effectiveness of TBP-PI-HBr in Patients with Instrumentation, Anatomic or Functional Abnormalities: Secondary Analysis from ADAPT-PO Open
Background Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an oral carbapenem with activity against Enterobacterales uropathogens, including drug resistant strains. The ADAPT-PO trial demonstrated the non-inferiority of oral TBP-PI-HBr vs. …
View article: 1727. Phase 1b Dose-ranging Study Demonstrates Tolerability and Pharmacokinetics (PK) of Oral Epetraborole at the Predicted Therapeutic Dosage for <i>Mycobacterium avium</i> Complex (MAC) Lung Disease
1727. Phase 1b Dose-ranging Study Demonstrates Tolerability and Pharmacokinetics (PK) of Oral Epetraborole at the Predicted Therapeutic Dosage for <i>Mycobacterium avium</i> Complex (MAC) Lung Disease Open
Background Epetraborole (EBO) — an orally available bacterial leucyl transfer RNA synthetase inhibitor with potent activity against nontuberculous mycobacteria — is under clinical development for treatment of MAC lung disease. We conducted…
View article: Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection
Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection Open
Oral tebipenem pivoxil hydrobromide was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis and had a similar safety profile. (Funded by Spero Therapeutics and the Departmen…
View article: Efficacy of Omadacycline Versus Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia by Disease Severity: Results From the OPTIC Study
Efficacy of Omadacycline Versus Moxifloxacin in the Treatment of Community-Acquired Bacterial Pneumonia by Disease Severity: Results From the OPTIC Study Open
Background Severity/mortality risk scores and disease characteristics may assist in deciding whether patients with community-acquired bacterial pneumonia (CABP) require outpatient treatment or hospitalization. The phase 3 OPTIC (Omadacycli…
View article: Clinical Efficacy of Patients With Secondary Bacteremia Treated With Omadacycline: Results From Phase 3 Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia Studies
Clinical Efficacy of Patients With Secondary Bacteremia Treated With Omadacycline: Results From Phase 3 Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia Studies Open
In this post hoc analysis of the 63 patients with secondary bacteremia enrolled in the 3 omadacycline phase 3 studies of acute bacterial skin/skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), we determin…
View article: Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Tebipenem Pivoxil Hydrobromide on QT/QTc Intervals in Healthy Subjects
Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Tebipenem Pivoxil Hydrobromide on QT/QTc Intervals in Healthy Subjects Open
Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an orally available prodrug of tebipenem (TBP), a carbapenem with in vitro activity against multidrug-resistant Gram-negative pathogens. This study evaluated the effects of single therapeutic …
View article: Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia
Omadacycline vs moxifloxacin in adults with community-acquired bacterial pneumonia Open
Omadacycline was non-inferior to moxifloxacin for IACR at PTE, with high clinical success across pathogen types and patient subgroups.
View article: 1687. Omadacycline in Female Adults With Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study
1687. Omadacycline in Female Adults With Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 Study Open
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 …
View article: 1688. Omadacycline in Female Adults With Cystitis: Results From a Randomized, Double-Blinded, Adaptive Phase 2 Study
1688. Omadacycline in Female Adults With Cystitis: Results From a Randomized, Double-Blinded, Adaptive Phase 2 Study Open
Background In a previous phase 1b study, ≥ 90% of patients with cystitis treated with omadacycline (OMC), a novel intravenous (IV) and oral aminomethylcycline, achieved clinical success. We assessed the safety and efficacy of OMC vs nitrof…
View article: 110. Clinical Outcomes of Patients with Secondary Bacteremia in the Omadacycline Phase 3 Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia Studies
110. Clinical Outcomes of Patients with Secondary Bacteremia in the Omadacycline Phase 3 Acute Bacterial Skin and Skin Structure Infections and Community-Acquired Bacterial Pneumonia Studies Open
Background Low serum concentrations of tetracycline antibiotics may raise concerns on their efficacy in patients with secondary bacteremia, especially in comorbid patients and in those with higher acuity of illness. Omadacycline (OMC), an …
View article: 720. Efficacy of Fosfomycin for Injection (FOS) vs. Piperacillin–Tazobactam (PIP-TAZ) in Adults with Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP): ZEUS Study Outcomes in Patients With Reduced Study Drug Susceptibility
720. Efficacy of Fosfomycin for Injection (FOS) vs. Piperacillin–Tazobactam (PIP-TAZ) in Adults with Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP): ZEUS Study Outcomes in Patients With Reduced Study Drug Susceptibility Open
Background FOS is being pursued for US registration in cUTI/AP. Safety and efficacy of FOS vs. PIP-TAZ were demonstrated in the noninferiority ZEUS trial in hospitalized patients with cUTI/AP. Although FOS resistance has been observed in s…
View article: Safety, Pharmacokinetics, and Food Effect of Tebipenem Pivoxil Hydrobromide after Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
Safety, Pharmacokinetics, and Food Effect of Tebipenem Pivoxil Hydrobromide after Single and Multiple Ascending Oral Doses in Healthy Adult Subjects Open
Tebipenem pivoxil hydrobromide (TBPM-PI-HBr, formerly SPR994) is an orally available prodrug of tebipenem, a carbapenem with activity versus multidrug-resistant (MDR) Gram-negative pathogens, including quinolone-resistant and extended-spec…
View article: Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with β-Lactam Antibiotics in Healthy Subjects
Safety, Tolerability, Pharmacokinetics, and Drug Interaction Potential of SPR741, an Intravenous Potentiator, after Single and Multiple Ascending Doses and When Combined with β-Lactam Antibiotics in Healthy Subjects Open
SPR741 is a novel polymyxin B derivative, with minimal intrinsic antibacterial activity and reduced nonclinical nephrotoxicity compared to levels with polymyxin B, that interacts with the outer membrane of Gram-negative bacteria, enhancing…
View article: Omadacycline for Acute Bacterial Skin and Skin Structure Infections
Omadacycline for Acute Bacterial Skin and Skin Structure Infections Open
Background Within 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. Methods…
View article: Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial
Fosfomycin for Injection (ZTI-01) Versus Piperacillin-tazobactam for the Treatment of Complicated Urinary Tract Infection Including Acute Pyelonephritis: ZEUS, A Phase 2/3 Randomized Trial Open
Background ZTI-01 (fosfomycin for injection) is an epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has broad in vitro spectrum of activity, including mult…
View article: Omadacycline for Community-Acquired Bacterial Pneumonia
Omadacycline for Community-Acquired Bacterial Pneumonia Open
Omadacycline was noninferior to moxifloxacin for the treatment of community-acquired bacterial pneumonia in adults. (Funded by Paratek Pharmaceuticals; OPTIC ClinicalTrials.gov number, NCT02531438 .).
View article: 1347. Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials
1347. Omadacycline for Acute Bacterial Skin and Skin Structure Infections: Integrated Analysis of Randomized Clinical Trials Open
Background Skin infections are a significant medical burden for affected individuals and the healthcare system. The purpose of this investigation was to integrate the findings of two randomized studies of omadacycline (OMC) in ABSSSI. Meth…
View article: 1367. Clinical Cure in Secondary Efficacy Populations in Patients With Complicated Urinary Tract Infection Treated With ZTI-01 (Fosfomycin for Injection): Findings From the ZEUS Trial
1367. Clinical Cure in Secondary Efficacy Populations in Patients With Complicated Urinary Tract Infection Treated With ZTI-01 (Fosfomycin for Injection): Findings From the ZEUS Trial Open
Background ZTI-01 (fosfomycin for injection) is an investigational epoxide antibiotic with a differentiated mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has a broad spectrum of in vitro activi…
View article: Single- and Multiple-Dose Study To Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of Oral MRX-I versus Linezolid in Healthy Adult Subjects
Single- and Multiple-Dose Study To Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of Oral MRX-I versus Linezolid in Healthy Adult Subjects Open
A multipart phase 1 study was conducted to determine the safety, tolerability, pharmacokinetics, and food effect of the novel oral oxazolidinone, MRX-I, in healthy adults, as well as the tolerability of longer-term exposure of both oral MR…
View article: Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI)
Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI) Open
ZTI-01 (fosfomycin [FOS] for injection) has in vitro activity against Gram-positive and -negative organisms, including carbapenem-resistant Enterobacteriaceae. This activity, coupled with a primarily renal route of elimination, makes ZTI-0…
View article: Phenotypic Antibiotic Resistance in ZEUS: A Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 vs. Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP)
Phenotypic Antibiotic Resistance in ZEUS: A Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 vs. Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) Open
Phenotypic resistance profiles are frequently employed to target appropriate antibiotic treatments. With increasing rates of resistance, antibiotics with a new mechanisms of action are needed. ZTI-01 (fosfomycin for injection) is an inject…
View article: Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) Who Received Intravenous Fosfomycin (ZTI-01)
Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) Who Received Intravenous Fosfomycin (ZTI-01) Open
Intravenous (IV) fosfomycin has been extensively used over four decades outside the USA. ZTI-01 (fosfomycin for injection) is an injectable epoxide antibiotic with a unique mechanism of action and broad in vitro spectrum of activity, inclu…
View article: A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of IV to Oral Omadacycline to Moxifloxacin for the Treatment of Adult Subjects with CABP (The OPTIC Study)
A Phase 3 Randomized, Double-blind, Multi-center Study to Compare the Safety and Efficacy of IV to Oral Omadacycline to Moxifloxacin for the Treatment of Adult Subjects with CABP (The OPTIC Study) Open
BackgroundOmadacycline (OMC), a novel aminomethylcycline antibiotic, has demonstrated non-inferiority to linezolid for the treatment of acute bacterial skin and skin structure infections. Here we report the results of Omadacycline for Pneu…
View article: Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS)
Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS) Open
ZTI-01 (fosfomycin for injection) is a novel injectable epoxide antibiotic with a unique mechanism of action (MOA) inhibiting an early step in bacterial cell wall synthesis. ZTI-01 has a broad in vitro spectrum of activity, including multi…