Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. ( 1.1 ) Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. ( 1.2 ) Community-acquired pneumonia. FDA label
Also known as ertapenem sodium (MK0826), ertapenem sodium, MK-0826, INVANZ®
ertapenem · 4 trials · 4 indications
The investigator assessed participants for a favorable clinical response, defined as clinical improvement or cure. Clinical improvement means that most pretherapy signs and symptoms of the index infection, in particular fever, lympangitis, and purulent drainage had resolved, and no further IV antibiotic therapy was required. Cure means that all pretherapy signs and symptoms of the index infection had resolved, and no further IV antibiotic therapy was required.
Percentage of participants who have no signs or symptoms of infection at the surgical site, do not require surgical intervention for infection, and have no need for further antimicrobial therapy
The difference in favorable microbiological response rates between the 2 treatment groups (MK0826 response rate minus ceftriaxone response rate) was assessed
Safety was assessed by statistical and/or clinical review of all safety parameters, including adverse experiences, physical examination, vital signs, and laboratory results during parenteral therapy. As per the primary safety hypothesis, it was expected that, at the end of the parenteral therapy only, MK0826 would be similar to ceftriaxone with respect to the proportion of patients with any drug-related clinical or laboratory adverse experiences leading to discontinuation of study drug and also with respect to the proportion of patients with any serious drug-related adverse experiences.
| Arm | Type | Description |
|---|---|---|
| Ertapenem sodium | EXPERIMENTAL | Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 |
| Piperacillin/tazobactam sodium | ACTIVE_COMPARATOR | Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 |
| Ertapenem sodium 1 g | EXPERIMENTAL | Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose |
| Ceftriaxone sodium 2 g | ACTIVE_COMPARATOR | Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose |
| ertapenem sodium (MK0826) | EXPERIMENTAL | ertapenem sodium |
| ceftriaxone sodium | ACTIVE_COMPARATOR | ceftriaxone sodium |
| 1 | EXPERIMENTAL | Arm 1: ertapenem sodium |
| Name | Type | Description |
|---|---|---|
| Ertapenem sodium | DRUG | Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days |
| Piperacillin/tazobactam sodium | DRUG | Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days |
| Piperacillin/tazobactam-matching placebo | DRUG | Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days |
| Amoxicillin/clavulunate potassium | DRUG | If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28 |
| ceftriaxone sodium | DRUG | Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
| placebo to metronidazole | DRUG | Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
| metronidazole | DRUG | Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision |
| ertapenem sodium (MK0826) | DRUG | a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) |
| Comparator: ceftriaxone sodium | DRUG | a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy) |
Inclusion Criteria: Participant is Chinese with: * Type I diabetes mellitus (IDDM) or Type II diabetes mellitus (NIDDM) treated with diet and/or medication * Clinically- or bacteriologically-documented moderate-to-severe (non life-threatening) diabetic foot infection that requires treatment with I...
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Ertapenem is an antibiotic studied for treating bacterial infections, including diabetic foot infections, complicated urinary tract infections, and infection following colorectal surgery. It has been evaluated in Phase 3 clinical trials in Chinese adults and other patient populations. It is a small molecule anti-infective developed by Merck & Company, Inc.
Ertapenem is developed by Merck & Company, Inc., which trades under the ticker MRK. The company conducted the Phase 3 clinical program for the drug, including trials in diabetic foot infection, complicated urinary tract infection, and post-colorectal surgery infection.
Ertapenem has been studied in Phase 3 clinical trials. The trials listed are completed, with no active trials currently recruiting. The development program includes studies in diabetic foot infections, complicated urinary tract infections, and infection following colorectal surgery.
Ertapenem has been evaluated in completed Phase 3 trials including NCT01370616 in diabetic foot infections, NCT01254344 following colorectal surgery, NCT01014013 in complicated urinary tract infections, and NCT00379951 in complicated urinary tract infections. These trials enrolled adults and used active-controlled, double-blind designs.
Yes, ertapenem is also known as ertapenem sodium, and has been referred to by the development code MK0826 or MK-0826. These names refer to the same antibiotic compound developed by Merck & Company, Inc.