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cefazolin

Phase 1

Sepsis | Small molecule | Infectious Disease |Smith & Nephew SNATS, Inc.|Last Updated: Sep 4, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

cefazolin · 1 trial · 2 indications

Phase 1 1
NCT00850122An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm NeonatesSepsis
COMPLETED9 Analytics
PHASE1COMPLETED
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Sepsis
NCT008501229
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Study Endpoints

Primary Endpoints

Cefazolin pharmacokinetics including half life, clearance, and volume of distribution
Dose 1 and Dose 4

Secondary Endpoints

Safety
7 days following last dose of cefazolin
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CefazolinEXPERIMENTALDosage Number of Infants ≤28 days of age 25 mg/kg IV q12 6 29-120 days of age 25 mg/kg IV q8 6

Interventions

NameTypeDescription
cefazolinDRUGCefazolin dosing - administered for 48 hours Dosage ≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8
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Eligibility Criteria

Age Range48 Hours to 120 Days
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * \< 28 weeks gestation at birth * \> 48 hours and \<121 days of age at the time of study drug administration * One of the following: * Suspected systemic infection * Receiving cefazolin for prophylaxis * Receiving cefazolin treatment of a systemic infection Exclusion Cr...

Countries:Brazil
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Competitive Landscape -Sepsis 17 trials

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2AZD4144
ImmunityBio IncIBRX1PHASE2Nogapendekin alfa inbakicept
Bluejay Diagnostics, Inc.BJDX2 - Undisclosed
CytoSorbents CorporationCTSO1 - Undisclosed
Danaher CorporationDHR3 - Undisclosed
Spectral AI, Inc. Class AMDAI1N/AUndisclosed
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Frequently asked questions about cefazolin

What is cefazolin used for in sepsis?

Cefazolin is a small molecule antibiotic being studied for use in sepsis, specifically in preterm neonates with suspected or confirmed sepsis. It is currently in Phase 1 clinical development as an investigational drug. The drug is being evaluated for its pharmacokinetics in this vulnerable patient population.

Who makes cefazolin?

Cefazolin is being developed by Smith & Nephew SNATS, Inc., a company listed on the New York Stock Exchange under the ticker SNN. The company is conducting clinical research to evaluate the drug's use in preterm neonates with sepsis.

What phase is cefazolin in?

Cefazolin is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is complete, having enrolled 9 participants to study the drug's pharmacokinetics in preterm neonates.

What clinical trials is cefazolin in?

Cefazolin has one completed clinical trial registered as NCT00850122, titled "An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates." This Phase 1 trial enrolled 9 participants in Brazil and studied the drug in neonates as young as 48 hours old.

How does cefazolin work?

Cefazolin is a small molecule antibiotic. It works by interfering with bacterial cell wall synthesis, which is essential for bacterial growth and survival. This mechanism makes it effective against certain bacterial infections, including those that can cause sepsis in preterm neonates.