Oral Tebipenem Pivoxil Hydrobromide in Complicated Urinary Tract Infection.
Paul B Eckburg1, Lori Muir1, Ian A Critchley1
1From Spero Therapeutics, Cambridge, MA (P.B.E., L.M., I.A.C., S.W., H.K., A.-M.P., A.J., T.K., D.M., A.K.T.); Moore Computing Services, Little Rock, AR (G.M.); and DaneStat Consulting, Macclesfield, United Kingdom (A.D.).
The New England Journal of Medicine
|April 7, 2022
Summary
Oral tebipenem pivoxil hydrobromide is a new antibiotic option for complicated urinary tract infections. It demonstrated non-inferiority to intravenous ertapenem with a comparable safety profile in a phase 3 trial.
Area of Science:
- Infectious Diseases
- Pharmacology
- Urology
Background:
- Rising rates of multidrug-resistant gram-negative uropathogens necessitate novel oral antibiotic therapies.
- Tebipenem pivoxil hydrobromide, an oral carbapenem, exhibits activity against key uropathogenic Enterobacterales, including resistant strains.
Purpose of the Study:
- To evaluate the efficacy and safety of oral tebipenem pivoxil hydrobromide compared to intravenous ertapenem.
- To assess tebipenem pivoxil hydrobromide in treating complicated urinary tract infections (cUTI) and acute pyelonephritis.
Main Methods:
- Phase 3, international, double-blind, double-dummy, randomized controlled trial.
- 1372 hospitalized adult patients with cUTI or acute pyelonephritis were randomized (1:1) to oral tebipenem pivoxil hydrobromide or IV ertapenem for 7-10 days.
- Primary endpoint: overall response (clinical cure + microbiologic response) at test-of-cure visit.
Main Results:
- Oral tebipenem pivoxil hydrobromide showed non-inferiority to IV ertapenem (58.8% vs. 61.6% overall response).
- Clinical cure rates were high and similar between groups (93.1% vs. 93.6%).
- Adverse events were comparable, with mild diarrhea and headache being most common.
Conclusions:
- Oral tebipenem pivoxil hydrobromide is a viable, non-inferior alternative to IV ertapenem for cUTI and acute pyelonephritis.
- The safety profile of tebipenem pivoxil hydrobromide is similar to that of ertapenem.
- This study supports the use of oral tebipenem pivoxil hydrobromide for specific urinary tract infections.
Related Concept Videos
01:30Urinary Tract Infection III: Diagnostic Studies and Interprofessional Care
56
A healthcare provider can diagnose a urinary tract infection (UTI) through several methods:Medical History and Symptoms: The provider will take a detailed medical history and ask about symptoms such as frequent urination, burning sensation during urination, and lower abdominal pain.Urinalysis: A clean-catch urine sample is collected in a sterile container and tested for the presence of bacteria, white blood cells (leukocytes), nitrites, blood, and protein. The presence of leukocytes and...
56
01:17Urinary Tract Infection IV: Nursing Management
108
In managing urinary tract infections (UTIs) in nursing, a comprehensive assessment is essential. Begin by gathering subjective data, such as the patient’s complaints of dysuria (painful urination), urinary frequency, urgency, suprapubic pain, and any lower abdominal discomfort. This information can be complemented by questions regarding previous UTIs, sexual activity, and personal hygiene practices, which can provide insight into risk factors. Objective assessment should focus on signs...
108
01:28Acute Pyelonephritis II: Diagnostic Studies and Management
61
Introduction:For diagnosing acute pyelonephritis, a comprehensive patient history is collected to identify symptoms such as dysuria, frequent or urgent urination, flank pain, or costovertebral angle (CVA) tenderness that may suggest a kidney infection.Physical ExaminationDuring the physical examination, CVA tenderness is assessed. This involves gentle percussion over the costovertebral angle, where tenderness often indicates a kidney infection.Diagnostic TestsUrinalysis: Used to identify white...
61
01:28Pneumonia IV: Management
470
The treatment of pneumonia varies based on its severity and the causative pathogen. Here is a structured approach to managing pneumonia, integrating pharmaceutical and supportive care strategies.
Bacterial Pneumonia Treatment
For bacterial pneumonia, antibiotics serve as the cornerstone of therapy. Initial treatment often begins with empirical antibiotics, tailored to the anticipated causative organism and adjusted based on culture results. Key antibiotic choices include:
Bacterial Pneumonia Treatment
For bacterial pneumonia, antibiotics serve as the cornerstone of therapy. Initial treatment often begins with empirical antibiotics, tailored to the anticipated causative organism and adjusted based on culture results. Key antibiotic choices include:
470
01:26Urinary Tract Infection I: Introduction
62
Urinary tract infections (UTIs) impact various parts of the urinary system, including the kidneys, ureters, bladder, and urethra. These infections are generally bacterial, with Escherichia coli being the most common causative agent, often originating from the gastrointestinal tract. However, other bacteria, such as Staphylococcus saprophyticus, Klebsiella pneumoniae, and Proteus mirabilis, are also known to cause UTIs. The type, location, and underlying complexity of the UTI guide both...
62
01:27Combined Effects of Drugs: Synergism
5.0K
Synergism is a useful mechanism where combining two or more drugs is more effective than each constituent used alone. Such combinations are also called supra-additive interactions. The drugs collectively enhance the final therapeutic effect by acting on different targets. Another advantage is that the low dose of each constituent drug is sufficient to achieve the desired effect. This helps reduce the duration of therapy and lower the adverse effects of these drugs.
Such synergistic combinations...
Such synergistic combinations...
5.0K