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
-

Multiple Treatments for Ebola Virus Disease (EVD)

First Posted Date
2015-03-05
Last Posted Date
2015-03-05
Lead Sponsor
Clinical Research Management, Inc.
Target Recruit Count
150
Registration Number
NCT02380625

Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis

First Posted Date
2015-02-26
Last Posted Date
2021-02-11
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
31
Registration Number
NCT02372383
Locations
🇺🇸

Children's Hospital Colroado, Aurora, Colorado, United States

Effectiveness Study of Integrative Treatment for Pediatric Community Acquired Pneumonia

First Posted Date
2015-02-13
Last Posted Date
2015-02-13
Lead Sponsor
Liaoning University of Traditional Chinese Medicine
Target Recruit Count
1500
Registration Number
NCT02362906
Locations
🇨🇳

Affiliated Children's Hospital of Capital University of Medical Sciences, Beijing, Beijing, China

🇨🇳

Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, Guangxi, China

🇨🇳

Affiliated Hospital of Changchun University of TCM, Changchun, Jilin, China

and more 7 locations

Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

Phase 3
Completed
Conditions
Interventions
First Posted Date
2015-01-26
Last Posted Date
2018-10-31
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
583
Registration Number
NCT02344628
Locations
🇬🇧

London School of Hygiene and Tropical Medicine, London, United Kingdom

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Community Based Recruitment, Kavieng Subdistrict, New Ireland Province, Papua New Guinea

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School Based Recruitment, Nkwanta North District, Volta Region, Ghana

Azithromycin in Post Diarrheal Haemolytic and Uremic Syndrome

First Posted Date
2015-01-13
Last Posted Date
2021-10-04
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
148
Registration Number
NCT02336516
Locations
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Arnaud de Villeneuve Hospital, Montpellier, France

Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy

First Posted Date
2014-12-04
Last Posted Date
2018-01-26
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Target Recruit Count
129
Registration Number
NCT02307825
Locations
🇨🇦

Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

Medico-economic Impact of Screening Atopobium Vaginae and Gardnerella Vaginalis in Molecular Biology by "Point-of-care" During Pregnancy

First Posted Date
2014-11-11
Last Posted Date
2023-04-13
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Target Recruit Count
6800
Registration Number
NCT02288832
Locations
🇫🇷

Assistance Publique Hopitaux de Marseille, Marseille, France

🇫🇷

Hôpital Nord Assistance Publique Hôpitaux de Marseille, Marseille, France

TINN2: Treat Infection in NeoNates 2

Phase 3
Withdrawn
Conditions
Interventions
First Posted Date
2014-11-04
Last Posted Date
2016-02-25
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Registration Number
NCT02282176
Locations
🇫🇷

Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France

🇫🇷

Only for children pharmaceuticals (04CP), Paris, France

🇫🇷

Assistance Publique Hôpitaux de Paris (APHP), Paris, France

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A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

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2014-10-21
Last Posted Date
2016-01-22
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Registration Number
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Locations
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Mercury Street Medical Group, Butte, Montana, United States

Typhoid Fever: Combined vs. Single Antibiotic Therapy

First Posted Date
2014-08-22
Last Posted Date
2014-08-27
Lead Sponsor
Sheba Medical Center
Target Recruit Count
120
Registration Number
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Locations
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Dhulikhel hospital, Dhulikhel, Nepal

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