Phase 2
Completed N=137
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Source: ClinicalTrials.gov NCT00690378 ↗Enrolled (actual)
137
Serious AEs
5.9%
Results posted
May 2018
Primary outcomePrimary: Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit — 19; 25 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit |
19; 25 | — |
| SECONDARY Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit |
28; 36 | — |
| SECONDARY Clinical Outcome in CE Patients at the TOC Visit |
24; 29 | — |
| SECONDARY Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit |
20; 24 | — |
| SECONDARY Microbiological Outcome in ME Patients at the End of IV Therapy Visit |
25; 34 | — |
| SECONDARY Microbiological Outcome in ME Patients at the LFU Visit |
15; 18 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit |
1; 0 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit |
0; 1 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit |
24; 32 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit |
0; 1 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit |
1; 0 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit |
1; 0 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit |
0; 1 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit |
19; 23 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit |
0; 1 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit |
0; 0 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit |
1; 0 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit |
15; 17 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit |
0; 1 | — |
| SECONDARY Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00690378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.