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
-

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

First Posted Date
2011-09-12
Last Posted Date
2021-10-20
Lead Sponsor
Maisonneuve-Rosemont Hospital
Target Recruit Count
12
Registration Number
NCT01432080
Locations
🇨🇦

Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont), Montreal, Quebec, Canada

Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

First Posted Date
2011-08-03
Last Posted Date
2021-11-19
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
917
Registration Number
NCT01408082
Locations
🇺🇸

Eye Research Foundation, Newport Beach, California, United States

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Macy Eye Center, Los Angeles, California, United States

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Center for Sight, Inc., Fall River, Massachusetts, United States

and more 38 locations

Development of an Optimal Antibiotic Regime for Long-term Therapy in Stable Chronic Obstructive Pulmonary Disease (COPD)

First Posted Date
2011-07-20
Last Posted Date
2012-06-01
Lead Sponsor
University College, London
Target Recruit Count
200
Registration Number
NCT01398072
Locations
🇬🇧

Academic Unit of Respiratory Medicine, Royal Free Hospital, London, United Kingdom

Single-dose Azithromycin for the Treatment of Yaws

First Posted Date
2011-06-27
Last Posted Date
2012-04-13
Lead Sponsor
Lihir Medical Centre
Target Recruit Count
255
Registration Number
NCT01382004
Locations
🇵🇬

Lihir Medical Centre, Kavieng, New Ireland Province, Papua New Guinea

Use of Azithromycin as Immunomodulatory Therapy in Grave&Apos;s Orbitopathy

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2011-06-23
Last Posted Date
2017-04-27
Lead Sponsor
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Registration Number
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Comparison of Two Macrolides, Azithromycin and Erythromycin, for Symptomatic Treatment of Gastroparesis

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2011-03-25
Last Posted Date
2014-12-05
Lead Sponsor
University of Florida
Target Recruit Count
26
Registration Number
NCT01323582
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

Targeted Therapy of Bronchiolitis Obliterans Syndrome

First Posted Date
2011-03-03
Last Posted Date
2017-10-04
Lead Sponsor
Stephanie Lee
Target Recruit Count
36
Registration Number
NCT01307462
Locations
🇺🇸

Stanford University, Stanford, California, United States

🇺🇸

Mayo Clinic - Scottsdale, Scottsdale, Arizona, United States

🇺🇸

National Cancer Institute Experimental Transplantation & Immunology Branch, Bethesda, Maryland, United States

and more 8 locations

Treatment of Preschool Children With Upper Respiratory Tract Illnesses Using Azythromycin and Lower Respiratory Tract Symptoms Using Oral Corticosteroids.

First Posted Date
2011-01-10
Last Posted Date
2016-12-28
Lead Sponsor
Milton S. Hershey Medical Center
Target Recruit Count
607
Registration Number
NCT01272635
Locations
🇺🇸

Emory University, Atlanta, Georgia, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

🇺🇸

University of Arizona College of Medicine, Tucson, Arizona, United States

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Prevention of Bronchiectasis in Infants With Cystic Fibrosis

First Posted Date
2011-01-05
Last Posted Date
2021-09-16
Lead Sponsor
The University of Queensland
Target Recruit Count
130
Registration Number
NCT01270074
Locations
🇦🇺

Sydney Children's Hospital, Sydney, New South Wales, Australia

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Perth Children's Hospital, Perth, Western Australia, Australia

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Queensland Children's Hospital, Brisbane, Queensland, Australia

and more 6 locations

Antibiotic Treatment of Recurrent Episodes of Asthma in Children

First Posted Date
2010-11-03
Last Posted Date
2024-08-16
Lead Sponsor
Copenhagen Studies on Asthma in Childhood
Target Recruit Count
70
Registration Number
NCT01233297
Locations
🇩🇰

Copsac, DBAC, Gentofte, Copenhagen, Denmark

🇩🇰

Copsac, Næstved Hospital, Pediatric Department, Naestved, Denmark

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