Trial Outcomes & Findings for Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections (NCT NCT00690378)

NCT ID: NCT00690378

Last Updated: 2018-05-25

Results Overview

Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 137 participants
• Primary outcome timeframe: 5 to 9 days post-therapy
• Results posted on: 2018-05-25

Participant Flow

Participant milestones

Measure	NXL104/CAZ NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin Imipenem cilastatin 500mg 4xdaily
Overall Study STARTED	69	68
Overall Study Treated	68	67
Overall Study COMPLETED	49	54
Overall Study NOT COMPLETED	20	14

Reasons for withdrawal

Measure	NXL104/CAZ NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin Imipenem cilastatin 500mg 4xdaily
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	2	0
Overall Study Protocol Violation	1	0
Overall Study Lost to Follow-up	2	3
Overall Study Did not meet inc/exc criteria	13	11
Overall Study Social problem	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NXL104/CAZ n=68 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=67 Participants Imipenem cilastatin 500mg 4xdaily	Total n=135 Participants Total of all reporting groups
Age, Continuous	46.4 Years STANDARD_DEVIATION 18.24 • n=5 Participants	49.9 Years STANDARD_DEVIATION 18.44 • n=7 Participants	48.15 Years STANDARD_DEVIATION 18.34 • n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants	49 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Number of Participants With Microbiological Outcome at the Test of Cure (TOC) Visit	19 Participants	25 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=28 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=36 Participants Imipenem cilastatin 500mg 4xdaily
Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit	28 Participants	36 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=28 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=36 Participants Imipenem cilastatin 500mg 4xdaily
Clinical Outcome in CE Patients at the TOC Visit	24 Participants	29 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=36 Participants Imipenem cilastatin 500mg 4xdaily
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit	20 Participants	24 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome in ME Patients at the End of IV Therapy Visit	25 Participants	34 Participants

SECONDARY outcome

Timeframe: 4 to 6 weeks post-therapy

Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=26 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=30 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome in ME Patients at the LFU Visit	15 Participants	18 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the End of IV Therapy Visit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the End of IV Therapy Visit	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=24 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=32 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the End of IV Therapy Visit	24 Participants	32 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the End of IV Therapy Visit	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the End of IV Therapy Visit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the TOC Visit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen E. Cloacae in ME Patients at the TOC Visit	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=25 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=33 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the TOC Visit	19 Participants	23 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the TOC Visit	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 5 to 9 days post-therapy

Eradication: a uropathogen found at entry at >10^5 CFU/mL was reduced to <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the TOC Visit	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 to 6 weeks post-therapy

Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen C. Koseri in ME Patients at the LFU Visit	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 to 6 weeks post-therapy

Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=24 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=29 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen E. Coli in ME Patients at the LFU Visit	15 Participants	17 Participants

SECONDARY outcome

Timeframe: 4 to 6 weeks post-therapy

Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Mirabilis in ME Patients at the LFU Visit	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4 to 6 weeks post-therapy

Sustained eradication: a uropathogen found at entry at >10^5 CFU/mL remained <10^4 CFU/mL

Outcome measures

Measure	NXL104/CAZ n=27 Participants NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=35 Participants Imipenem cilastatin 500mg 4xdaily
Microbiological Outcome for the Urine Pathogen P. Aeruginosa in ME Patients at the LFU Visit	0 Participants	0 Participants

Adverse Events

NXL104/CAZ

Serious events: 6 serious events

Other events: 30 other events

Deaths: 0 deaths

Imipenem Cilastatin

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	NXL104/CAZ n=68 participants at risk NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=67 participants at risk Imipenem cilastatin 500mg 4xdaily
Cardiac disorders Atrial Fibrillation	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Gastrointestinal disorders Diarrhoea	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Infections and infestations Urosepsis	0.00% 0/68 • Baseline up to 19 days	1.5% 1/67 • Baseline up to 19 days
Injury, poisoning and procedural complications Accidental Overdose	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Injury, poisoning and procedural complications Blood Creatinine Increased	0.00% 0/68 • Baseline up to 19 days	1.5% 1/67 • Baseline up to 19 days
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Renal and urinary disorders Renal Failure Acute	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Renal and urinary disorders Renal Impairment	1.5% 1/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days

Other adverse events

Measure	NXL104/CAZ n=68 participants at risk NXL104 125mg/Ceftazidime 500mg TID	Imipenem Cilastatin n=67 participants at risk Imipenem cilastatin 500mg 4xdaily
Gastrointestinal disorders Constipation	10.3% 7/68 • Baseline up to 19 days	3.0% 2/67 • Baseline up to 19 days
Gastrointestinal disorders Diarrhoea	7.4% 5/68 • Baseline up to 19 days	10.4% 7/67 • Baseline up to 19 days
Gastrointestinal disorders Abdominal Distension	0.00% 0/68 • Baseline up to 19 days	7.5% 5/67 • Baseline up to 19 days
Gastrointestinal disorders Abdominal Pain	7.4% 5/68 • Baseline up to 19 days	4.5% 3/67 • Baseline up to 19 days
Gastrointestinal disorders Abdominal Pain Upper	7.4% 5/68 • Baseline up to 19 days	1.5% 1/67 • Baseline up to 19 days
General disorders Infusion Site Reaction	2.9% 2/68 • Baseline up to 19 days	14.9% 10/67 • Baseline up to 19 days
General disorders Injection Site Reaction	4.4% 3/68 • Baseline up to 19 days	9.0% 6/67 • Baseline up to 19 days
General disorders Chest Pain	5.9% 4/68 • Baseline up to 19 days	4.5% 3/67 • Baseline up to 19 days
General disorders Alanine Aminotransferase Increased	2.9% 2/68 • Baseline up to 19 days	6.0% 4/67 • Baseline up to 19 days
Musculoskeletal and connective tissue disorders Back Pain	2.9% 2/68 • Baseline up to 19 days	6.0% 4/67 • Baseline up to 19 days
Nervous system disorders Headache	19.1% 13/68 • Baseline up to 19 days	31.3% 21/67 • Baseline up to 19 days
Nervous system disorders Dizziness	5.9% 4/68 • Baseline up to 19 days	0.00% 0/67 • Baseline up to 19 days
Psychiatric disorders Anxiety	10.3% 7/68 • Baseline up to 19 days	7.5% 5/67 • Baseline up to 19 days
Psychiatric disorders Insomnia	5.9% 4/68 • Baseline up to 19 days	6.0% 4/67 • Baseline up to 19 days
Vascular disorders Hypertension	5.9% 4/68 • Baseline up to 19 days	3.0% 2/67 • Baseline up to 19 days

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER