Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections

Phase 2

Completed

• Conditions: Complicated Urinary Tract Infection
• Interventions: Drug: NXL104/ceftazidime; Drug: Imipenem/Cilastatin

• Registration Number: NCT00690378
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated urinary tract infections as compared to a comparator group.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Study Start: 2008-11
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2017-09-01
• Status Verified: 2018-03
• Results First Submitted QC: 2018-04-27
• Last Update Submitted: 2018-04-27
• Results First Posted: 2018-05-25
• Last Update Posted: 2018-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens

Exclusion Criteria

• ileal loops or vesicoureteral reflux
• complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess.
• fungal urinary tract infection
• permanent indirect catheter or nephrostomy unless removed within 48 hours of study entry
• history hypersensitivity to study medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NXL104/ceftazidime	NXL/104 ceftazidime
2	Imipenem/Cilastatin	comparator 4 x daily

Primary Outcome Measures

Name	Time	Method
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL

Secondary Outcome Measures

Name	Time	Method
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit	4 to 6 weeks post-therapy	Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Clinical Outcome in CE Patients at the TOC Visit	5 to 9 days post-therapy	Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit	4 to 6 weeks post-therapy	Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome in ME Patients at the LFU Visit	4 to 6 weeks post-therapy	Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit	4 to 6 weeks post-therapy	Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit	End of IV therapy (4 to 14 days)	Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Microbiological Outcome in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit	End of IV therapy (4 to 14 days)	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit	4 to 6 weeks post-therapy	Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit	5 to 9 days post-therapy	Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit	4 to 6 weeks post-therapy	Sustained eradication: a uropathogen found at entry at \>10\^5 CFU/mL remained \<10\^4 CFU/mL

Trial Locations

Locations (58)

Alabama Research Center; 🇺🇸 Birmingham, Alabama, United States

Southeast Alabama Medical Center; 🇺🇸 Dothan, Alabama, United States

Providence Hospital; 🇺🇸 Mobile, Alabama, United States

Arizona Pulmonary Specialists LTD; 🇺🇸 Phoenix, Arizona, United States

Sharp Chula Vista Medical Center; 🇺🇸 Chula Vista, California, United States

Synergy Clinical Research Center; 🇺🇸 Escondido, California, United States

Novellus Research Sites; 🇺🇸 Long Beach, California, United States

Modesto Clinical Research; 🇺🇸 Modesto, California, United States

Tri City Medical Center; 🇺🇸 Oceanside, California, United States

EStudy Site; 🇺🇸 San Jose, California, United States

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