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CXA-101

Phase 2

Complicated Urinary Tract Infection | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 18, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

CXA-101 · 1 trial · 1 indication

Phase 2 1
NCT00921024Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract InfectionsComplicated Urinary Tract Infection
COMPLETED129 Analytics
PHASE2COMPLETED
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Complicated Urinary Tract InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
TOC; 6-9 days after last study drug administration

Microbiological response is eradication for each baseline pathogen

Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
TOC; 6-9 days after last study drug administration

Microbiological response is eradication for each baseline pathogen

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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALCXA-101
2ACTIVE_COMPARATORCeftazidime

Interventions

NameTypeDescription
CXA-101DRUGintravenous
CeftazidimeDRUGintravenous
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: 1. Males and females 18 to 90 years of age, inclusive. 2. Pyuria (white blood cell \[WBC\] count \> 10/µL in unspun urine or ≥ 10 per high power field in spun urine) 3. Clinical signs and/or symptoms of cUTI, either of: a. Pyelonephritis, as indicated by both of the followin...

Countries:United StatesGermanyPoland
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Frequently asked questions about CXA-101

What is CXA-101 used for?

CXA-101 is an investigational small molecule being studied for complicated urinary tract infections, complicated intra-abdominal infections, and in healthy subjects for safety evaluations. It is in Phase 2 clinical development for the infectious disease therapeutic area.

Who makes CXA-101?

CXA-101 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in infectious disease indications.

What phase is CXA-101 in?

CXA-101 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.

What clinical trials is CXA-101 in?

CXA-101 has completed three clinical trials. NCT00921024 studied it in complicated urinary tract infections with 129 participants. NCT01147640 evaluated it in complicated intra-abdominal infections with 122 participants. NCT02508753 assessed its effects on QT/QTc intervals in 52 healthy subjects.

Is CXA-101 the same as CXA-101/Tazobactam?

CXA-101 is the base drug, and CXA-101/Tazobactam is a combination formulation that includes tazobactam. Clinical trials have evaluated both the single agent and the combination, with the combination studied in intra-abdominal infections and healthy subjects.