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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00690378
• Collaborator: (none)
• Enrollment: 137
• Locations: 59
• Arms: 2
• Duration (Months): 19.9
• Patients Per Site: 2.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Urinary Tract Infection	Drug: NXL104/ceftazidime; Drug: Imipenem/Cilastatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Prospective, Multicenter, Investigator-blinded, Randomized, Comparative Study Estimate Safety, Tolerability, Efficacy of NXL104/Ceftazidime vs. Comparator Followed Appropriate Oral Therapy Treatment Complicated UTI Hosp Adults
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 NXL/104 ceftazidime	Drug: NXL104/ceftazidime; 125mg/500mg TID
Active Comparator: 2 comparator 4 x daily	Drug: Imipenem/Cilastatin; 4 x daily

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Research Center	Birmingham	Alabama	United States	35209
2	Southeast Alabama Medical Center	Dothan	Alabama	United States	36301
3	Providence Hospital	Mobile	Alabama	United States	36608
4	Arizona Pulmonary Specialists LTD	Phoenix	Arizona	United States
5	Sharp Chula Vista Medical Center	Chula Vista	California	United States	91911
6	Synergy Clinical Research Center	Escondido	California	United States
7	Novellus Research Sites	Fountain Valley	California	United States
8	Novellus Research Sites	Long Beach	California	United States
9	Modesto Clinical Research	Modesto	California	United States
10	Tri City Medical Center	Oceanside	California	United States	92056
11	EStudy Site	San Jose	California	United States
12	Olive View UCLA Medical Center	Sylmar	California	United States
13	Christiana Care Health Services	Newark	Delaware	United States
14	Century Clinical Research, Inc	Daytona Beach	Florida	United States
15	University of Florida	Jacksonville	Florida	United States
16	Southeast Regional Research Group	Columbus	Georgia	United States
17	St. Joseph's/Candler Health System	Savannah	Georgia	United States
18	Four Rivers Clinical Research Inc	Paducah	Kentucky	United States
19	Louisiana State University Health Services Ctr Shreveport	Shreveport	Louisiana	United States	71103
20	R. Adams Cowley Shock Trauma Center	Baltimore	Maryland	United States
21	Henry Ford Hospital	Detroit	Michigan	United States	48202
22	North Memorial Medical Center	Minneapolis	Minnesota	United States	55422
23	Saint Louis University Hospital	Saint Louis	Missouri	United States
24	St. James Healthcare	Butte	Montana	United States
25	Jersey Shore University Medical Center	Neptune	New Jersey	United States	07754
26	Newark Beth Israel Medical Center	Newark	New Jersey	United States
27	University Hospital UMDNJ	Newark	New Jersey	United States
28	Albany Medical Center	Albany	New York	United States	12208
29	Brookdale University Hospital	Brooklyn	New York	United States
30	Vassar Brothers Medical Center	Poughkeepsie	New York	United States
31	Staten Island University Hospital	Staten Island	New York	United States	10305
32	Mission Hospital	Asheville	North Carolina	United States
33	Clinical Trials of America Inc.	Winston-Salem	North Carolina	United States	27103
34	Summa Health System Hospitals	Akron	Ohio	United States	44304
35	Remington-Davis	Columbus	Ohio	United States
36	Regional Infectious Disease-Infusion Center	Lima	Ohio	United States	45801
37	St Vincent's Mercy Medical Center	Toledo	Ohio	United States	43608
38	Thomas Jefferson Univ Hospital	Philadelphia	Pennsylvania	United States
39	Reading Hospital and Medical Center	West Reading	Pennsylvania	United States	19611
40	Harris Methodist	Azle	Texas	United States
41	University of Texas MD Anderson	Houston	Texas	United States
42	Sentara Norfold General Hospital	Norfolk	Virginia	United States
43	Al-Essra hospital	Amman		Jordan
44	Al-Islami Hospital	Amman		Jordan
45	Jordan University Hospital	Amman		Jordan
46	King Abdullah University Hospital	Irbid		Jordan
47	Clinique due Levant Hospital	Beirut		Lebanon
48	Dr. Rizk Clinic	Beirut		Lebanon
49	Makassed General Hospital	Beirut		Lebanon
50	Rafik Hariri University Hospital	Beirut		Lebanon
51	Sahel General Hospital	Beirut		Lebanon
52	Notre Dame Des Secours Hospital	Byblos		Lebanon
53	Ain Wazein Hospital	Chouf		Lebanon
54	St. Joseph Hospital	Dora		Lebanon
55	Mount Lebanon Hospital	Hazmieh		Lebanon
56	Nabatyeh Governmental Hospital	Nabatyeh		Lebanon
57	Hammoud Hospital University Medical Center	Saida		Lebanon
58	Labib Medical Center	Saida		Lebanon
59	Saida Governmental Hospital	Saida		Lebanon

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer
• Study Director: Carole A Sable, MD, Novexel Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00690378
• Other Study ID Numbers: NXL104/2001; C3591013
• First Posted: Jun 4, 2008
• Last Update Posted: May 25, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Infections; Urinary Tract Infections; Imipenem; Ceftazidime; Avibactam; Cilastatin

Study Results

Participant Flow

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Period Title: Overall Study
STARTED	69	68
Treated	68	67
COMPLETED	49	54
NOT COMPLETED	20	14

Baseline Characteristics

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin	Total
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily	Total of all reporting groups
Overall Participants	68	67	135
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	46.4 (18.24)	49.9 (18.44)	48.15 (18.34)
Sex: Female, Male (Count of Participants)
Female	51 75%	49 73.1%	100 74.1%
Male	17 25%	18 26.9%	35 25.9%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	19 27.9%	25 37.3%

2. Secondary Outcome

Title	Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
Description	Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	28	36
Number [Participants]	28 41.2%	36 53.7%

3. Secondary Outcome

Title	Clinical Outcome in CE Patients at the TOC Visit
Description	Cure: all or most pre-therapy signs and symptoms of the index infection had resolved and no additional antibiotic was required
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	28	36
Number [Participants]	24 35.3%	29 43.3%

4. Secondary Outcome

Title	Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
Description	Cure: all or most pre-therapy signs and symptoms of the index infection showed no evidence of resurgence and no additional antibiotic was required
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	36
Number [Participants]	20 29.4%	24 35.8%

5. Secondary Outcome

Title	Microbiological Outcome in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	25 36.8%	34 50.7%

6. Secondary Outcome

Title	Microbiological Outcome in ME Patients at the LFU Visit
Description	Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	26	30
Number [Participants]	15 22.1%	18 26.9%

7. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	1 1.5%	0 0%

8. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	1 1.5%

9. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	24	32
Number [Participants]	24 35.3%	32 47.8%

10. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	1 1.5%

11. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	End of IV therapy (4 to 14 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	1 1.5%	0 0%

12. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	1 1.5%	0 0%

13. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	1 1.5%

14. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	25	33
Number [Participants]	19 27.9%	23 34.3%

15. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	1 1.5%

16. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit
Description	Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL
Time Frame	5 to 9 days post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	0 0%

17. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit
Description	Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	1 1.5%	0 0%

18. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit
Description	Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	24	29
Number [Participants]	15 22.1%	17 25.4%

19. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit
Description	Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	1 1.5%

20. Secondary Outcome

Title	Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit
Description	Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL
Time Frame	4 to 6 weeks post-therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NXL104/CAZ	Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID	Imipenem cilastatin 500mg 4xdaily
Measure Participants	27	35
Number [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Baseline up to 19 days
Arm/Group Title	NXL104/CAZ		Imipenem Cilastatin
Arm/Group Description	NXL104 125mg/Ceftazidime 500mg TID		Imipenem cilastatin 500mg 4xdaily
All Cause Mortality
	NXL104/CAZ		Imipenem Cilastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	NXL104/CAZ		Imipenem Cilastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/68 (8.8%)		2/67 (3%)
Cardiac disorders
Atrial Fibrillation	1/68 (1.5%)		0/67 (0%)
Gastrointestinal disorders
Diarrhoea	1/68 (1.5%)		0/67 (0%)
Infections and infestations
Urosepsis	0/68 (0%)		1/67 (1.5%)
Injury, poisoning and procedural complications
Accidental Overdose	1/68 (1.5%)		0/67 (0%)
Blood Creatinine Increased	0/68 (0%)		1/67 (1.5%)
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion	1/68 (1.5%)		0/67 (0%)
Renal and urinary disorders
Renal Failure Acute	1/68 (1.5%)		0/67 (0%)
Renal Impairment	1/68 (1.5%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	NXL104/CAZ		Imipenem Cilastatin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/68 (44.1%)		33/67 (49.3%)
Gastrointestinal disorders
Constipation	7/68 (10.3%)		2/67 (3%)
Diarrhoea	5/68 (7.4%)		7/67 (10.4%)
Abdominal Distension	0/68 (0%)		5/67 (7.5%)
Abdominal Pain	5/68 (7.4%)		3/67 (4.5%)
Abdominal Pain Upper	5/68 (7.4%)		1/67 (1.5%)
General disorders
Infusion Site Reaction	2/68 (2.9%)		10/67 (14.9%)
Injection Site Reaction	3/68 (4.4%)		6/67 (9%)
Chest Pain	4/68 (5.9%)		3/67 (4.5%)
Alanine Aminotransferase Increased	2/68 (2.9%)		4/67 (6%)
Musculoskeletal and connective tissue disorders
Back Pain	2/68 (2.9%)		4/67 (6%)
Nervous system disorders
Headache	13/68 (19.1%)		21/67 (31.3%)
Dizziness	4/68 (5.9%)		0/67 (0%)
Psychiatric disorders
Anxiety	7/68 (10.3%)		5/67 (7.5%)
Insomnia	4/68 (5.9%)		4/67 (6%)
Vascular disorders
Hypertension	4/68 (5.9%)		2/67 (3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.