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Daptomycin

Phase 3

Skin Diseases | Small molecule | Infectious Disease |AstraZeneca PLC|Last Updated: Mar 9, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment265

FDA Designations

No designations recorded

Clinical trial landscape

Daptomycin · 2 trials · 3 indications

Phase 3 1Phase 1 1
NCT00772447China Registration Study in Patients With Skin InfectionsSkin Diseases
COMPLETED265 Analytics
PHASE3COMPLETED
China Registration Study in Patients With Skin Infections
Skin DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)
baseline to TOC(test of cure), for up to 4 weeks

Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood

Change in Creatinine Clearance
baseline to TOC(test of cure), for up to 4 weeks
Change in Serum Total Creatine Phosphokinase (CPK)
baseline to TOC(test of cure), for up to 4 weeks
Change in Urine pH
baseline to TOC(test of cure), for up to 4 weeks
Shift in ECG
baseline to TOC(test of cure), for up to 4 weeks

percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline

Pharmacokinetic data will be obtained from the analysis of blood and urine samples that will be obtained at specific time points throughout the study. The pharmacokinetic samples will be collected on days 1, 4 through 8 and 9.
On therapy evaluation on Day1~9.

Secondary Endpoints

Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)
baseline and TOC, for up to 4 weeks
Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)
baseline and EOT(end of therapy), for up to 2 weeks
Microbiological Response at TOC(Test of Cure)
baseline and TOC, for up to 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZ drugEXPERIMENTALDaptomycin
ComparatorACTIVE_COMPARATORVancomycin or Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin

Interventions

NameTypeDescription
DaptomycinDRUG4mg/kg IV ; Q 24 hr (once every 24 hours)
VancomycinDRUGVancomycin - 1g per 12 hrs, for 7-14 days Or switch to Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin: \- 1 g every 6 hours or 2 g every 8 hours
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Provision of inform consent * A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria * Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections inv...

Countries:China
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Frequently asked questions about Daptomycin

What is Daptomycin used for?

Daptomycin is a small molecule antibiotic used for skin infections. It is being studied in healthy subjects for pharmacokinetic purposes. The drug is in clinical development for skin diseases, including infectious skin conditions.

Who makes Daptomycin?

Daptomycin is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting clinical trials for this drug in China.

What phase is Daptomycin in?

Daptomycin is in Phase 1 clinical development. It has completed a Phase 1 pharmacokinetic study in healthy Chinese subjects and a Phase 3 registration study in patients with skin infections.

What clinical trials is Daptomycin in?

Daptomycin has two completed clinical trials. NCT00772447 is a Phase 3 registration study in patients with skin infections in China, enrolling 265 participants. NCT00858325 is a Phase 1 pharmacokinetic study in healthy Chinese subjects, enrolling 24 participants.

Is Daptomycin the same as Cubicin?

Daptomycin is also known by the brand name Cubicin. The drug is being studied for skin infections and in healthy subjects for pharmacokinetic evaluation.