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
-

Antibiotics for Children With Severe Diarrhoea

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-04-26
Last Posted Date
2020-05-19
Lead Sponsor
World Health Organization
Target Recruit Count
8268
Registration Number
NCT03130114
Locations
🇲🇼

Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi

🇧🇩

Icddr,B, Dhaka, Bangladesh

🇵🇰

Aga Khan University, Karachi, Pakistan

and more 4 locations

Healthy Patients & Effect of Antibiotics

First Posted Date
2017-03-31
Last Posted Date
2022-11-10
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
20
Registration Number
NCT03098485
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Vitamin A and Azithromycin for Acne Vulgaris

Early Phase 1
Conditions
Interventions
First Posted Date
2017-03-24
Last Posted Date
2021-02-25
Lead Sponsor
Manchanda Medical Clinic
Target Recruit Count
30
Registration Number
NCT03090048
Locations
🇨🇦

Manchanda Mc, Surrey, British Columbia, Canada

Treatment of ppROM With Erythromycin vs. Azithromycin Trial

First Posted Date
2017-02-23
Last Posted Date
2024-06-25
Lead Sponsor
The University of Texas Medical Branch, Galveston
Target Recruit Count
21
Registration Number
NCT03060473
Locations
🇺🇸

St. David's North Austin Medical Center, Austin, Texas, United States

🇺🇸

University of Texas Medical Branch, Galveston, Texas, United States

🇺🇸

University of Utah, Salt Lake City, Utah, United States

Effect of Azithromycin on Fatty Acids in CF

Phase 4
Conditions
Interventions
First Posted Date
2017-02-07
Last Posted Date
2018-08-02
Lead Sponsor
University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn)
Target Recruit Count
20
Registration Number
NCT03045198

Intestinal Microbiome Post-Azythromycin/Albendazole Treatment

First Posted Date
2017-01-26
Last Posted Date
2021-06-28
Lead Sponsor
University of California, San Francisco
Registration Number
NCT03032042
Locations
🇪🇹

The Carter Center Ethiopia, Addis Ababa, Ethiopia

A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia

Phase 4
Completed
Conditions
Interventions
First Posted Date
2016-11-25
Last Posted Date
2020-02-21
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
364
Registration Number
NCT02972957
Locations
🇬🇲

Medical Research Council unit The Gambia, Banjul, Gambia

Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2016-11-09
Last Posted Date
2018-10-02
Lead Sponsor
Vanderbilt University
Registration Number
NCT02960503
Locations
🇺🇸

Vanderbilt University Medical Center, Nashville, Tennessee, United States

The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-10-06
Last Posted Date
2016-10-24
Lead Sponsor
Mereo BioPharma
Target Recruit Count
16
Registration Number
NCT02926326
Locations
🇬🇧

BioKinetic Europe Ltd, Belfast, United Kingdom

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