Drug Safety
Conditions
Brief summary
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.
Detailed description
Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.
Interventions
DRUGErtapenem
Ertapenem 1 gram per day for 7 to 14 days
Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients aged \>18 years with documented ESBL +ve GNB infection * Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy
Exclusion criteria
* Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours * Have active P. aeruginosa co-infection * Pregnancy or breast feeding * Allergy to carbapenems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with cure or improvement | 14 days | Cure Improvement Persistence Death from Infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with eradication of the causative bacteria | 14 days | Eradication Persistence Superinfection |
Countries
Thailand
Contacts
Primary ContactVisanu Thamlikitkul, MD
Outcome results
None listed