MedPath

Clarithromycin

Generic Name
Clarithromycin
Brand Names
Biaxin, Biaxin Bid, Omeclamox, Prevpac, Voquezna 14 Day Triplepak 20;500;500
Drug Type
Small Molecule
Chemical Formula
C38H69NO13
CAS Number
81103-11-9
Unique Ingredient Identifier
H1250JIK0A
Background

Clarithromycin, a semisynthetic macrolide antibiotic derived from erythromycin, inhibits bacterial protein synthesis by binding to the bacterial 50S ribosomal subunit. Binding inhibits peptidyl transferase activity and interferes with amino acid translocation during the translation and protein assembly process. Clarithromycin may be bacteriostatic or bactericidal depending on the organism and drug concentration.

Indication

An alternative medication for the treatment of acute otitis media caused by H. influenzae, M. catarrhalis, or S. pneumoniae in patients with a history of type I penicillin hypersensitivity. Also for the treatment of pharyngitis and tonsillitis caused by susceptible Streptococcus pyogenes, as well as respiratory tract infections including acute maxillary sinusitis, acute bacterial exacerbations of chronic bronchitis, mild to moderate community-acquired pneuomia, Legionnaires' disease, and pertussis. Other indications include treatment of uncomplicated skin or skin structure infections, helicobacter pylori infection, duodenal ulcer disease, bartonella infections, early Lyme disease, and encephalitis caused by Toxoplasma gondii (in HIV infected patients in conjunction with pyrimethamine). Clarithromycin may also decrease the incidence of cryptosporidiosis, prevent the occurence of α-hemolytic (viridans group) streptococcal endocarditis, as well as serve as a primary prevention for Mycobacterium avium complex (MAC) bacteremia or disseminated infections (in adults, adolescents, and children with advanced HIV infection).

Clarithromycin is indicated in combination with vonoprazan and amoxicillin as co-packaged triple therapy to treat Helicobacter pylori (H. pylori) infection in adults.

Associated Conditions
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB), Acute maxillary sinusitis, Bacterial Infections, Bartonellosis, Community Acquired Pneumonia (CAP), Duodenal ulcer caused by helicobacter pylori, Helicobacter Pylori Infection, Infective Endocarditis (IE), Lyme Disease, Mycobacterial Infections, Otitis Media (OM), Pertussis, Streptococcal Pharyngitis, Tonsillitis streptococcal, Uncomplicated skin and subcutaneous tissue bacterial infections
Associated Therapies
-

The Safety and Effectiveness of Clarithromycin Plus Zidovudine or Dideoxyinosine in the Treatment of Mycobacterium Avium Complex (MAC) Infections in Children With AIDS

Phase 1
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2008-08-04
Lead Sponsor
Abbott
Target Recruit Count
24
Registration Number
NCT00000971
Locations
🇺🇸

Children's Hosp of Los Angeles, Los Angeles, California, United States

🇺🇸

Natl Cancer Institute / HIV / AIDS Malignancy Branch, Bethesda, Maryland, United States

Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

Phase 3
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-04
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
400
Registration Number
NCT00001047
Locations
🇺🇸

Henry Ford Hosp, Detroit, Michigan, United States

🇺🇸

Southern New Jersey AIDS Cln Trials / Dept of Med, Camden, New Jersey, United States

🇺🇸

Richmond AIDS Consortium, Richmond, Virginia, United States

and more 13 locations

A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS

Phase 2
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
246
Registration Number
NCT00001058
Locations
🇺🇸

Indiana Univ. School of Medicine, Infectious Disease Research Clinic, Indianapolis, Indiana, United States

🇺🇸

Methodist Hosp. of Indiana, Indianapolis, Indiana, United States

🇺🇸

Harbor-UCLA Med. Ctr. CRS, Torrance, California, United States

and more 31 locations

Evaluation of Treatment for Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients

Phase 2
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2012-10-31
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT00001039
Locations
🇺🇸

UMDNJ - New Jersey Med School / Cooper Hosp, Camden, New Jersey, United States

🇺🇸

Univ of Maryland at Baltimore, Baltimore, Maryland, United States

🇺🇸

Richmond AIDS Consortium, Richmond, Virginia, United States

and more 5 locations

The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Not Applicable
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2012-10-31
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
91
Registration Number
NCT00001023
Locations
🇺🇸

Univ of Maryland at Baltimore / Veterans Adm, Baltimore, Maryland, United States

🇺🇸

Denver Public Health Dept, Denver, Colorado, United States

🇺🇸

Med College of Virginia / School of Pharmacy, Richmond, Virginia, United States

and more 8 locations

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

Phase 1
Completed
Conditions
Bacterial Infections
Mycoses
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-10-29
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
48
Registration Number
NCT00000826
Locations
🇺🇸

University of Washington AIDS CRS, Seattle, Washington, United States

🇺🇸

Ucsf Aids Crs, San Francisco, California, United States

A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. Avium Complex (MAC) Infections in Patients With AIDS

Phase 2
Completed
Conditions
HIV Infections
Mycobacterium Avium-intracellulare Infection
First Posted Date
2001-08-31
Last Posted Date
2011-02-25
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
100
Registration Number
NCT00000644
Locations
🇺🇸

Rush Presbyterian - Saint Luke's Med Ctr, Chicago, Illinois, United States

🇺🇸

Univ of Southern California / LA County USC Med Ctr, Los Angeles, California, United States

🇺🇸

Johns Hopkins Hosp, Baltimore, Maryland, United States

The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

Phase 3
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
HIV Infections
First Posted Date
2001-08-31
Last Posted Date
2021-11-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
1100
Registration Number
NCT00001030
Locations
🇺🇸

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

🇺🇸

Rush Univ. Med. Ctr. ACTG CRS, Chicago, Illinois, United States

🇺🇸

Univ. of Miami AIDS CRS, Miami, Florida, United States

and more 39 locations

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis

Phase 2
Completed
Conditions
HIV Infections
Toxoplasmosis, Cerebral
First Posted Date
2001-08-31
Last Posted Date
2021-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
100
Registration Number
NCT00000794
Locations
🇺🇸

Northwestern University CRS, Chicago, Illinois, United States

🇺🇸

Cook County Hosp. CORE Ctr., Chicago, Illinois, United States

🇺🇸

Johns Hopkins Adult AIDS CRS, Baltimore, Maryland, United States

and more 13 locations

Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

Phase 2
Completed
Conditions
Mycobacterium Avium-intracellulare Infection
First Posted Date
2000-02-25
Last Posted Date
2015-03-25
Lead Sponsor
National Jewish Health
Target Recruit Count
50
Registration Number
NCT00004689
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