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Clarithromycin

Phase 3

Acute Bacterial Sinusitis (ABS) | Small molecule | ENT |Abbott Laboratories|Last Updated: Aug 11, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment437

FDA Designations

No designations recorded

Clinical trial landscape

Clarithromycin · 4 trials · 6 indications

Phase 3 3Phase 1 1
NCT00121550The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart DiseaseHeart Disease
COMPLETED4,372 Analytics
NCT00644553Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial SinusitisAcute Bacterial Sinusitis (ABS)
COMPLETED437 Analytics
NCT00645086Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic BronchitisAcute Bacterial Exacerbation of Chronic Bronchitis (ABECB).
COMPLETED465 Analytics
PHASE3COMPLETED
The CLARICOR Trial: Effect of Clarithromycin on Mortality and Morbidity in Patients With Ischemic Heart Disease
Heart DiseaseUnlock trial analytics
PHASE3COMPLETED
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
Acute Bacterial Sinusitis (ABS)Unlock trial analytics
PHASE3COMPLETED
Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB).Unlock trial analytics

Study Endpoints

Primary Endpoints

Composite consisting of: death regardless of cause
non-fatal AMI or
unstable angina pectoris whichever occurred first
Clinical Response
33 days
Bacteriologic Response
23 days

Secondary Endpoints

Composite of: cardiovascular death
non-fatal AMI or
unstable angina pectoris whichever occurred first
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ClarithromycinEXPERIMENTALClarithromycin is a lipophilic semi-synthetic macrolide antibiotic. The lipophilic nature of the drug allows it to easily penetrate into body fluids and tissues and accumulate intracellularly. Side effects are few, apart from trivial gastrointestinal complaints, and severe side effects are rarely observed during standard treatment.
PlaceboPLACEBO_COMPARATORPlacebo comparator
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -

Interventions

NameTypeDescription
clarithromycinDRUG -
AmoxicillinDRUGAmoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
clarithromycin extended-release tabletsDRUG5-day course of clarithromycin extended-release tablets (2 x 500 mg QD)
clarithromycin immediate-release tabletsDRUG7-day course of clarithromycin immediate-release tablets (1 x 500 mg BID)
ZidovudineDRUG -
DidanosineDRUG -
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Eligibility Criteria

Age Range18 Years to 84 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * patients aged 18 to 85 years and * previous acute myocardial infarction (AMI) or * previous or present angina pectoris and * signed informed concent Exclusion Criteria: * AMI or unstable angina pectoris within the last three months * revascularisation (PTCA or CABG) within t...

Countries:DenmarkUnited StatesCanadaGreeceHungaryItalyLithuaniaPolandRomaniaSpainPuerto Rico
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Frequently asked questions about Clarithromycin

What is Clarithromycin used for?

Clarithromycin is a small molecule antibiotic studied for Mycobacterium Avium-intracellulare Infection, Heart Disease, and Acute Bacterial Sinusitis (ABS). It is being developed by Abbott Laboratories (NYSE: ABT) and is currently in Phase 3 clinical trials for these indications.

What does Clarithromycin target?

Clarithromycin is a macrolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible bacteria, preventing the growth and replication of the microorganisms causing the infection.

Who makes Clarithromycin?

Clarithromycin is being developed by Abbott Laboratories, a company publicly traded under the ticker symbol ABT on the New York Stock Exchange. Abbott is conducting clinical trials to evaluate the drug's safety and efficacy for multiple indications.

What phase is Clarithromycin in?

Clarithromycin is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are evaluating its use for Heart Disease and Acute Bacterial Sinusitis, while earlier phase trials have been completed.

What clinical trials is Clarithromycin in?

Clarithromycin has been studied in several clinical trials. NCT00000971 evaluated its safety and effectiveness in children with Mycobacterium Avium Complex infections. NCT00121550, the CLARICOR trial, assessed its effect on mortality in patients with ischemic heart disease. NCT00644553 compared extended-release Clarithromycin to amoxicillin-clavulanate for acute bacterial sinusitis.

Is Clarithromycin the same as Biaxin?

Clarithromycin is the generic name for the antibiotic also known as Biaxin. It is a macrolide antibiotic used to treat various bacterial infections, including those affecting the respiratory tract and skin. Abbott Laboratories markets the drug under the brand name Biaxin.