Urinary Tract Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of ertapenem sodium as initial therapy for the treatment of complicated urinary tract infections, including pyelonephritis in indian adults.
Interventions
DRUGertapenem sodium
ertapenem sodium as a single dose of 1gm I.V. was infused over a 30 min interval for a minimum of 3 days to a maximum of 14 days.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has a complicated urinary tract infection * Patient has acute pyelonephritis with fever, flank pain, pus in the urine, and positive urine culture * Patient is indian and 18 years of age or greater.
Exclusion criteria
* Patient had a kidney transplant * Patient had been given antibiotic therapy for condition * Patient had poor liver function * Patient has complete obstruction of urinary tract * Patient has history of serious allergy to antibiotics and multivitamins * Patient is pregnant * Patient not likely to respond to 10 to 14 days of antibiotic therapy * Patient not likely to survive 4 week study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability | 14 Days |
Secondary
| Measure | Time frame |
|---|---|
| Compare signs and symptoms of urinary tract infections at 14 days after treatment compared with signs and symptoms before treatment | 14 days after treatment |
Outcome results
None listed