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Cefepime- AAI101

Phase 3

Urinary Tract Infections | Small molecule | Infectious Disease |Medpace Holdings, Inc. Common Stock|Last Updated: Mar 10, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment1,088

FDA Designations

No designations recorded

Clinical trial landscape

Cefepime- AAI101 · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT03687255Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract InfectionsUrinary Tract Infections
COMPLETED1,043 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Cefepime-AAI101 in the Treatment of Complicated Urinary Tract Infections
Urinary Tract Infections
NCT036872551,043
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Study Endpoints

Primary Endpoints

Proportion of patients in the Microbiological Modified Intent to Treat (m-MITT) Population who achieve overall treatment success at Test Of Cure (TOC)
7 days after EOT [±2 days] for patients receiving 7 days of treatment and 19 days after randomization [±2 days] for patients receiving more than 7 days of treatment.

Treatment success is defined as the composite of clinical outcome of Cure and the microbiological outcome of Eradication (\<103 CFU/mL in urine culture).

Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-Treat (mMITT) Population
6 to 9 days post-End of Treatment

Microbiological response is eradication for each baseline pathogen

Secondary Endpoints

Proportion of patients in the m-MITT Population with overall treatment success at End of Treatment (EOT)
7 days for patients with cUTI only and up to 14 days for patients cUTI and blood stream infections
Microbiological Response at the TOC Visit in the Microbiologically Evaluable (ME) Population.
6 to 9 days post-End of Treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
cefepime/AAI101 combinationEXPERIMENTALCefepime 2 g in combination with AAI101 500 mg q8h (2 hour infusion)
piperacillin/tazobactamACTIVE_COMPARATORPiperacillin 4 g in combination with Tazobactan 500 mg q8h (2 hour infusion)
Cefepime 1G - 2G / AAI101 0.5G - 0.75GEXPERIMENTALcefepime 1 g or cefepime 2 g in combination with AAI101 500 mg or 750 mg
cefepime monotherapyACTIVE_COMPARATORcefepime 1 g or cefepime 2 g

Interventions

NameTypeDescription
cefepime/AAI101 combinationDRUGcefepime 2 g / AAI101 500 mg
Piperacillin/tazobactamDRUGpiperacillin 4 GM / tazobactam 500 MG
Cefepime 1G - 2G / AAI101 0.5G - 0.75GDRUGExperimental drug
cefepime 1 g or cefepime 2 gDRUGcefepime monotherapy
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria 1. Male or female patients \>18 years of age at the time of signing of informed consent; 2. Expectation that the patient's cUTI or AP will require hospitalisation and initial treatment with at least 7 days of intravenous (i.v.) antibiotics; 3. Female patients who are no longer of...

Countries:United StatesArgentinaBelarusBulgariaCroatiaEstoniaGeorgiaHungaryLatviaLithuaniaMexicoPeruPolandRussiaSerbiaSlovakiaSouth AfricaSpainUkraineCzechia
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Competitive Landscape -Urinary Tract Infections 5 trials

Top 2 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK2PHASE1Gepotidacin, UTI vaccine candidate
CorMedix Inc.CRMD1PHASE2Meropenem-Vaborbactam
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