Omadacycline Effective, Safe for Pneumonia and Skin Infections in Patients With Renal Insufficiency: Presented at ECCMID

By Shazia Qureshi

AMSTERDAM, the Netherlands -- April 16, 2019 -- Omadacycline appears to be effective and safe in patients with community-acquired bacterial pneumonia (CABP) or acute bacterial skin and skin structure infection (ABSSSI) who also have mild or moderate renal insufficiency, omadacycline appears to be effective and safe, according to a study presented here at the 29th European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

Oliver A. Cornely, MD, University Hospital of Cologne, Cologne, Germany, and colleagues evaluated data from 3 phase 3 trials of omadacycline and stratified the patient data by renal function.

He noted that approximately 30% of omadacycline is cleared through the renal system, therefore, it is important to examine its safety in patients with renal insufficiency.

Two of the trials compared omadacycline with linezolid in patients with ABSSSI and the other trial compared omadacycline with moxifloxacin in patients with CABP.

The intent-to-treat population consisted of 1,390 patients in the ABSSSI trials and 774 patients in the CABP trial, while the safety population numbered 1,380 and 770 patients, respectively.

Mild or moderate renal insufficiency was noted at baseline in 11.4% of patients in the ABSSSI studies and in 46.8% of patients in the CABP study.

Compared with patients with normal renal function, patients with renal insufficiency were found to be older, had more comorbidities, and weighed less.

The study defined mild renal insufficiency as creatinine clearance of 60 to 89 mL/min, moderate renal insufficiency was 31-59 mL/min, and normal renal function was >89 mL/min. None of the 3 studies included patients with severe renal disease or creatinine clearance of ≤30 mL/min.

The researchers found that both efficacy endpoints measured -- early clinical response and clinical response at the post-treatment evaluation -- were similar across all patients, irrespective of renal sufficiency.

However, there seemed to be a numerical difference between treatments in patients with moderate renal insufficiency in the ABSSSI trials, with 74% of omadacycline-treated versus 90% of linezolid-treated patients achieving early clinical response, and 95% of omadacycline-treated versus 84% of linezolid-treated patients achieving post-treatment evaluation clinical response.

Early clinical response in the ABSSSI studies was defined as survival with a reduction in the size of the lesion by at least 20%. In the study of patients with CABP, it was defined as survival with improvement in at least 2 CABP symptoms (cough, sputum production, pleuritic chest pain, and dyspnea), other symptoms not worsening, and no administration of rescue antibacterial therapy.

In the CABP trial, patients with renal insufficiency reported more treatment-emergent adverse events (TEAEs) than patients with normal renal function. This was the case for both omadacycline treatment (48.6% vs 34.5%) and moxifloxacin treatment (51.9% vs 45.4%). Serious TEAE rates were higher among patients with moderate renal insufficiency (omadacycline, 15.1% and moxifloxacin, 10.1%).

Funding for this study was provided by Paratek Pharmaceuticals.
[Presentation title: Safety and Efficacy of Omadacycline for Treatment of Community-Acquired Bacterial Pneumonia and Acute Bacterial Skin and Skin Structure Infections in Patients With Mild to Moderate Renal Insufficiency. Abstract O0304]

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