A Prospective, Multicentric, Double-blind, Randomized and Comparative Study to evaluate the safety, tolerability and efficacy of MK 0826 versus Ceftriaxone in the treatment of complicated urinary tract infections in adults

Not Applicable

• Conditions: -N039 Chronic nephritic syndrome, unspecified; Chronic nephritic syndrome, unspecified; N039

• Registration Number: PER-013-98
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1998-06-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified