Ertapenem

Generic Name: Ertapenem

Brand Names: Invanz, Ertapenem SUN

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₅N_₃O_₇S

CAS Number: 153832-46-3

Unique Ingredient Identifier: G32F6EID2H

Background: Ertapenem is a 1-β methyl-carbapenem that is structurally related to beta-lactam antibiotics. It was first authorized for use in the US in November 2001 and in Europe in April 2002. Shown to be effective against a wide range of Gram-positive and Gram-negative aerobic and anaerobic bacteria, ertapenem is used to treat various bacterial infections.

Indication: Ertapenem is indicated to treat the following moderate to severe infections caused by susceptible bacteria in adult and pediatric patients (three months of age and older):

Ertapenem is also used in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

Associated Conditions: Acute Gynecological Infection, Severe Community-acquired Pneumonia (sCAP), Surgical Site Infections, Acute, moderate Pelvic Infections caused by susceptible bacteria, Acute, severe susceptible bacteria Pelvic Infections, Moderate Community acquired pneumonia, Moderate Complicated Intra-Abdominal Infections (cIAIs) caused by susceptible bacteria, Moderate Diabetic Foot Infection, Moderate Gynaecological infection caused by susceptible bacteria, Moderate Postpartum Endomyometritis caused by susceptible bacteria, Moderate Septic Abortion caused by susceptible bacteria, Moderate complicated Urinary Tract Infection caused by susceptible bacteria, Moderate complicated skin and skin-structure infections caused by susceptible bacteria, Severe Complicated Intra-Abdominal Infections (cIAIs) caused by susceptible bacteria, Severe Diabetic Foot Infection, Severe Gynaecological infection caused by susceptible bacteria, Severe Postpartum Endomyometritis caused by susceptible bacteria, Severe Septic Abortion caused by susceptible bacteria, Severe complicated Urinary Tract Infection caused by susceptible bacteria, Severe complicated skin and skin-structure infections caused by susceptible bacteria

Associated Therapies: -

Clinical Trials

Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Phase 2

Completed

Conditions: SURGICAL SITE INFECTION

Interventions: Drug: Ertapenem

First Posted Date: 2010-09-16

Last Posted Date: 2012-08-10

Lead Sponsor: Silvia M. Pinango L.

Target Recruit Count: 56

Registration Number: NCT01203046

An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.

Conditions: Urinary Tract Infections

First Posted Date: 2010-07-30

Last Posted Date: 2014-04-03

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 60

Registration Number: NCT01173068

Locations: 🇸🇬
National University Hospital, Singapore, Singapore

Safety of Ertapenem in Beta-lactam Allergic Patients.

Phase 4

Conditions: IgE-Mediated Hypersensitivity
Allergy

Interventions: Drug: ertapenem

First Posted Date: 2010-07-09

Last Posted Date: 2011-01-05

Lead Sponsor: Catholic University of the Sacred Heart

Target Recruit Count: 30

Registration Number: NCT01159379

Locations: 🇮🇹
Allergy Department, Catholic University of the Sacred Heart, Rome, Italy

Pharmacokinetics (PK) of Ertapenem Intravenous (IV) Bolus Versus Standard Infusion

Phase 4

Completed

Conditions: Healthy

Interventions: Drug: ertapenem

First Posted Date: 2010-06-22

Last Posted Date: 2012-05-11

Lead Sponsor: Hartford Hospital

Target Recruit Count: 12

Registration Number: NCT01148771

Locations: 🇺🇸
Hartford Hospital, Hartford, Connecticut, United States

Moxifloxacin in Pediatric Subjects With Complicated Intra-abdominal Infection

Phase 3

Completed

Conditions: Intraabdominal Infections

Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Ertapenem
Drug: Amoxicillin/Clavulanate
Drug: Ertapenem placebo
Drug: Amoxicillin/Clavulanate placebo
Drug: Moxifloxacin placebo

First Posted Date: 2010-02-17

Last Posted Date: 2018-03-20

Lead Sponsor: Bayer

Target Recruit Count: 458

Registration Number: NCT01069900

Locations: 🇦🇷
Hospital de Agudos "Dr. Carlos Bocalandro", Tres De Febrero, Buenos Aires, Argentina

Appendicectomy Versus Antibiotics in the Treatment of Acute Uncomplicated Appendicitis

Not Applicable

Active, not recruiting

Conditions: Acute Appendicitis

Interventions: Procedure: Appendicectomy
Drug: Ertapenem

First Posted Date: 2009-12-01

Last Posted Date: 2018-06-28

Lead Sponsor: Turku University Hospital

Target Recruit Count: 530

Registration Number: NCT01022567

Locations: 🇫🇮
Turku University Hospital, Turku, Finland
🇫🇮
Keski-Suomi Central Hosptal, Jyväskylä, Finland
🇫🇮
Oulu University Hospital, Oulu, Finland

and more 3 locations