A clinical study to estimate and compare the safety, tolerability and efficacy of the study drug combined with ceftazidime to that of Imipenem-Cilastatin combination, for treatment of complicated Urinary tract infections in hospitalized adults.

Phase 2

Completed

• Registration Number: CTRI/2009/091/000959
• Lead Sponsor: ovexel, Inc2250 Hickory Road, Suite 216Plymouth Meeting, PA 19462

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens
2. Ages Eligible for Study: 18 Years to 65 Years
3. Genders Eligible for Study: Both

Exclusion Criteria

1. Ileal loops or vesicoureteral reflux
2. Complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
3. Fungal urinary tract infection
4. Permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
5. History hypersensitivity to study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and EffficacyTimepoint: 1. To estimate the by-patient microbiological response of study drug in the treatment of adult patients with cUTI in the microbiologically evaluable population as compared to imipenem cilastatin at the Test of Cure visit 5 to 9 days post-therapy.<br>2. To evaluate the safety and tolerability profile of study drug in the treatment of cUTI in adults.<br>

Secondary Outcome Measures

Name	Time	Method
EfficacyTimepoint: 1. Estimate the clinical outcome of NXL104/ceftazidime [ Time Frame: End of IV therapy, Test of Cure visit 5 to 9 days post-therapy and late follow-up visit ] [ Designated as safety issue: No ]<br><br>2. Estimate the by-pathogen microbiological response [ Time Frame: End of IV therapy, the Test of Cure visit 5 to 9 days post-therapy and at the late follow-up visit ] [ Designated as safety issue: No ]<br><br><br>