Azithromycin

Generic Name
Azithromycin
Brand Names
Azasite, Zithromax, Zmax
Drug Type
Small Molecule
Chemical Formula
C38H72N2O12
CAS Number
83905-01-5
Unique Ingredient Identifier
J2KLZ20U1M
Background

Azithromycin is a broad-spectrum macrolide antibiotic with a long half-life and a high degree of tissue penetration . It was initially approved by the FDA in 1991 .

It is primarily used for the treatment of respiratory, enteric and genitourinary infections and may be used instead of other macrolides for some sexually transmitted and enteric infections. It is structurally related to erythromycin .

Azithromycin [9-deoxo-9a-aza-9a-methyl-9a-homoerythromycin] is a part of the azalide subclass of macrolides, and contains a 15-membered ring, with a methyl-substituted nitrogen instead of a carbonyl group at the 9a position on the aglycone ring, which allows for the prevention of its metabolism. This differentiates azithromycin from other types of macrolides .

In March 2020, a small study was funded by the French government to investigate the treatment of COVID-19 with a combination of azithromycin and the anti-malaria drug hydroxychloroquine. The results were positive, all patients taking the combination were virologically cured within 6 days of treatment, however, larger studies are required.

Indication

Azithromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria in order to prevent the development antimicrobial resistance and maintain the efficacy of azithromycin .

Azithromycin is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the microorganisms listed in the specific conditions below. Recommended dosages, duration of therapy and considerations for various patient populations may vary among these infections. Refer to the FDA label and "Indications" section of this drug entry for detailed information .

Adults:

Acute bacterial exacerbations of chronic obstructive pulmonary disease due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae. Abscesses usually require surgical drainage.

Urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae.

Genital ulcer disease in men due to Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.

Pediatric Patients

Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae

Community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients appropriate for oral therapy.

Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.

Associated Conditions
Acute Bacterial Sinusitis (ABS), Acute Otitis Media (AOM), Acute bacterial exacerbation of COPD caused by Haemophilus Influenza Infections, Moraxella Catarrhalis Infection, Streptococcus Pneumoniae Infections, Bacterial Conjunctivitis, Bacterial Sinusitis, Cervicitis, Chancroid, Community Acquired Pneumonia (CAP), Genital Ulcer Disease (GUD), Pelvic Inflammatory Disease (PID), Pharyngitis, Streptococcal Pharyngitis, Tonsillitis bacterial, Tonsillitis streptococcal, Traveler's Diarrhea, Uncomplicated Skin and Skin Structure Infections, Urethritis
Associated Therapies
-

Empiric Therapy of Mucopurulent Cervicitis (MPC)

First Posted Date
2010-02-19
Last Posted Date
2014-12-24
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
87
Registration Number
NCT01072136
Locations
🇺🇸

University of Mississippi - Infectious Diseases, Jackson, Mississippi, United States

🇺🇸

Harbor UCLA Medical Center - OBGYN - General Gynecology and Women's Health, Torrance, California, United States

🇺🇸

Louisiana Stte University - Health Sciences Center - Medicine, New Orleans, Louisiana, United States

and more 1 locations

Cantharidin-induced Skin Blister for Testing Anti-inflammatory Effects of Macrolides

First Posted Date
2009-12-04
Last Posted Date
2017-07-25
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
44
Registration Number
NCT01026064
Locations
🇬🇧

GSK Investigational Site, Cambridge, Cambridgeshire, United Kingdom

Azithromycin in Bronchiolitis Obliterans Syndrome

First Posted Date
2009-11-09
Last Posted Date
2011-10-03
Lead Sponsor
KU Leuven
Target Recruit Count
83
Registration Number
NCT01009619
Locations
🇧🇪

Katholieke Universiteit Leuven and University Hospital Gasthuisberg, Leuven, Belgium

Trial for the Treatment of Acute Asthma in Wheezy Pre-school Aged Children

Not Applicable
Conditions
Interventions
First Posted Date
2009-11-06
Last Posted Date
2012-07-12
Lead Sponsor
Janielee Williamson
Target Recruit Count
440
Registration Number
NCT01008761
Locations
🇨🇦

Alberta Children's Hospital, Calgary, Alberta, Canada

🇨🇦

Stollery Children's Hospital, Edmonton, Alberta, Canada

Macrolide Maintenance Therapy in Chronic Obstructive Pulmonary Disease

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-09-28
Last Posted Date
2013-06-26
Lead Sponsor
R.S. Djamin
Target Recruit Count
92
Registration Number
NCT00985244
Locations
🇳🇱

Amphia Ziekenhuis, Breda, Noord-Brabant, Netherlands

Drug-Drug Interaction Study of Colchicine and Azithromycin

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-09-24
Last Posted Date
2009-10-28
Lead Sponsor
Mutual Pharmaceutical Company, Inc.
Target Recruit Count
24
Registration Number
NCT00983294

Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-09-18
Last Posted Date
2015-03-18
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
567
Registration Number
NCT00980148
Locations
🇺🇸

University of Alabama Hospital - Infectious Diseases, Birmingham, Alabama, United States

🇺🇸

Los Angeles County Department of Public Health - Sexually Transmitted Disease Program, Los Angeles, California, United States

Efficacy of Azithromycin Prophylaxis in Preventing Recurrent Acute Sinusitis in Children

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-07-23
Last Posted Date
2016-03-16
Lead Sponsor
Mahidol University
Target Recruit Count
40
Registration Number
NCT00944515
Locations
🇹🇭

Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand

Compliance And Safety Study In Children With Upper And Lower Respiratory Tract Infections

Completed
Conditions
Interventions
First Posted Date
2009-07-14
Last Posted Date
2010-03-30
Lead Sponsor
Pfizer
Target Recruit Count
400
Registration Number
NCT00939185

Efficacy of Combination Therapies for Gonorrhea Treatment

First Posted Date
2009-06-24
Last Posted Date
2015-08-19
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
614
Registration Number
NCT00926796
Locations
🇺🇸

San Francisco Department of Public Health - San Francisco City Clinic, San Francisco, California, United States

🇺🇸

University of Alabama Hospital - Infectious Diseases, Birmingham, Alabama, United States

🇺🇸

Los Angeles County Department of Public Health - Sexually Transmitted Disease Program, Los Angeles, California, United States

and more 2 locations
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