None listed
Conditions
Interventions
Group 1: MK-0826 as a single daily dose
Group 2: Ceftriaxone Type of group
Group 1: MK-0826 as a single daily dose of 1.0 g I.V. (infused over a 30-minute interval) plus placebo to ceftriaxone. Group 2: Ceftriaxone sodium as a single daily dose of 1.0 g I.V. (infused over a 30-minute interval) plus placebo to MK-0826. Study therapy may be compleied in hospital, in an outpatient clinic setting, or using home infusion after at least 2 to 3 days of in-hospital or clinic-based infusion therapy. Both treatment groups may be switched lo oral ciprofloxacin at a dose of 500 mg
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (age >18 years) with a clinically suspected and/or bacteriologicaliy documented complicated urinary tract infection or acute pyelonephritis judged by the investigator to be serious (requiring parenteral antibiotic therapy) according to the following diagnostic criteria: Acute Pyelonephritis 1) Patients with or without a history or curren! evidence of structural or functional urologic abnormalities; 2) Fever. defined as body temperature measurements >37.8°C (100°F) orally, >38.2°C (100.8°F) by tympanic, or >38.4°C (101.0°F) by rectal measurement, and chills 3)Flank Pain or costovertebral angle (CVA) tendemess on examination; paraplegic or quadriplegic patients without symptoms may be enrolled provided all other criteria are met; 4)Pyuria: determined by a midstream, clean-catch (MSCC), catheterized or suprapubic aspirated urine specimen with >10 WBCs per high power field (hpf) on standard examination of urine sediment or >10 WBCs/mm3 inunspun urine; Complicated Urinarv Tract Infection 1) Patients with one or more signs or symptoms of either upper or lower urinary tract infection including fever (or histoiy of fever), chills, flank pain, costovertebral (CVA) tendemess, dysuria, urgency, frequency, incontinence, suprapubic pain, nausea or vomiting; paraplegic or quadriplegic patients without symptoms may be enrolled provided all other criteria are met 2) Pyuria: determined by a MSCC or catheterized urine specimen with >10 WBCs per high power field (hpf) on standard examination of urine sediment or >10 WBCs/mm3 in unspun urine 3) Urine culture: one positive MSCC, catheterized or suprapubic aspirated urine specimen within 48 hours of enrollment; defined as ≥105 CFU/mL for a MSCC or indwelling catheter urine specimen (or ≥102 CFU/mL for a suprapubic or straight catheter specimen) of a uropathogen presumed or known to be susceptible to the intravenous study antibiotics (MK-0826 and ceftriaxone)
Exclusion criteria
Exclusion criteria: a. Failure to meet all inclusion criteria. b. Patients urine culture at admission is known to contain a uropathogen resistant to the study drugs. c. Patient has received any amount of effective concomitant antibiotic therapy after obtaining the uriñe culture for admission to this study (admission urine culture). d. Patient´s infection has been treated with >24 hours of systemic antibiotic therapy known to be effective against the presumed or documented etiologic pathogen(s) within the 72-hour period immediately prior to consideration for entry into the study (oniy patients with a positive admission uriñe culture will be considered microbiologically evaluable). Patients on prophylactic antibiotic therapy (e.g., nitrofurantoin) should beenrolled onlv if their admission culture is positive as described in the inclusion criteria. e. Patients with complete obstruction of any portion of the urinary tract, perinephric or intrarenal abscess, prostatitis or history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The results will be displayed separately by acute pyelonephritis or other complicated urinary tract infections and then combined overall. The end points that will be displayed for efficacy are the percentage of patients with a favorable clinical response, the percentage of patients with a favorable microbiologic response and the percentage of patients with both a favorable clinical and microbiological response. For each end point, the percentages and their 95% confidence interval will be displayed by treatment group, age and pathogen(s). A test Of treatment by strata interaction will be done. If there is no interaction present, the results will also be displayed by treatment group, combined overall. The end points will be displayed for the time points of: (1) the Study Day 3, 4, or 5 assessment; (2) the time of discontinuation of I.V. therapy; (3) the early follow-up 5 to 9 days posttherapy and (4) the 4 to 6 weeks posttherapy Time to discontinuation of I.V. therapy will be displayed using Kaplan-Meier estimates. Summary statistics for total number of days of all antibiotic therapy (I.V. only or I.V. plus oral) by treatment group will be displayed. The results Will be displayed separately for those patients who need I.V. only and for those patients who switch to oral, as well as combined. Measure:Efficacy Measurements Timepoints:the Study Day 3, 4, or 5 assessment; (2) the time of discontinuation of I.V. therapy; (3) the early follow-up 5 to 9 days posttherapy | — |
Countries
Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed