A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

CompletadoFase 3ClinicalTrials.gov

ID: NCT01599806Tipo: INTERVENTIONALInicio: 1 de oct de 2012Fin estimado: 1 de ago de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to Doripenem for treating hospitalized patients with complicated urinary tract infections, including acute pyelonephritis

Descripción detallada

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 90 YearsSexo: ALL

Criterios de inclusión

to 90 years of age inclusive
Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
Has pyuria with \>/= 10 WBCs (white blood cell) and has a positive urine culture within 48 hours of enrollment containing \>/=10 to the fifth CFU (colony forming unit ) /ml of a recognized uropathogen known to be susceptible to IV study therapy (CAZ-AVI and doripenem)
Demonstrates either acute pyelonephritis or complicated lower UTI without pyelonephritis

Criterios de exclusión

Urine pathogen is a Gram-positive pathogen or a uropathogen resistant to CAZ-AVI or doripenem
Patient's urine culture at study entry isolates more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
Patient is immunocompromised
Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

Intervenciones

drug

Ceftazidime - Avibactam ( CAZ-AVI)

Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes

drug

Doripenem

500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes

drug

Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

drug

or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)

Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement

Ubicaciones

Research Site

Rosario, Argentina

Patrocinadores

PrincipalPfizer

ColaboradorForest Laboratories

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