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NXL104/ceftazidime

Phase 2

Complicated Urinary Tract Infection | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: May 25, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment137

FDA Designations

No designations recorded

Clinical trial landscape

NXL104/ceftazidime · 1 trial · 1 indication

Phase 2 1
NCT00690378Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract InfectionsComplicated Urinary Tract Infection
COMPLETED137 Analytics
PHASE2COMPLETED
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Complicated Urinary Tract Infection
NCT00690378137
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Study Endpoints

Primary Endpoints

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 Endpoints

Clinical Outcome in Clinically Evaluable (CE) Patients at the End of Intravenous (IV) Therapy Visit
End of IV therapy (4 to 14 days)
Clinical Outcome in CE Patients at the TOC Visit
5 to 9 days post-therapy
Clinical Outcome in CE Patients at the Late Follow-up (LFU) Visit
4 to 6 weeks post-therapy
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALNXL/104 ceftazidime
2ACTIVE_COMPARATORcomparator 4 x daily

Interventions

NameTypeDescription
NXL104/ceftazidimeDRUG125mg/500mg TID
Imipenem/CilastatinDRUG4 x daily
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites59

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 infec...

Countries:United StatesJordanLebanon
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Frequently asked questions about NXL104/ceftazidime

What is NXL104 used for?

NXL104 is an investigational small molecule being studied for use in complicated urinary tract infections. It has been evaluated in clinical trials involving healthy volunteers and patients with this infection, typically in combination with ceftazidime or ceftaroline fosamil.

Who makes NXL104?

NXL104 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored clinical trials to evaluate the safety, tolerability, and efficacy of this investigational drug.

What phase is NXL104 in?

NXL104 is in clinical development, with completed trials in Phase 1 and Phase 2. It is not approved by the FDA and remains investigational. The most advanced completed study was a Phase 2 trial in patients with complicated urinary tract infections.

What clinical trials is NXL104 in?

NXL104 has been studied in several completed trials, including NCT00690378, a Phase 2 study in complicated urinary tract infections; NCT01290900, a Phase 1 QT interval study in healthy male volunteers; NCT01291602, a Phase 1 study in healthy Japanese subjects; and NCT01448395, a Phase 1 mass balance study.

How does NXL104 work?

NXL104 is a small molecule being studied as a beta-lactamase inhibitor, designed to be combined with antibiotics like ceftazidime to overcome bacterial resistance. It is being evaluated for its ability to restore the effectiveness of these antibiotics against resistant bacteria.