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
-

Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-03-30
Last Posted Date
2011-11-03
Lead Sponsor
Pfizer
Target Recruit Count
76
Registration Number
NCT00871494
Locations
🇯🇵

Pfizer Investigational Site, Okayama-city, Japan

Effects of Macrolides on Asthma Control

Phase 3
Completed
Conditions
Interventions
First Posted Date
2009-02-27
Last Posted Date
2011-10-19
Lead Sponsor
Euan J Cameron
Target Recruit Count
77
Registration Number
NCT00852579
Locations
🇬🇧

Crosshouse Hospital, Kilmarnock, United Kingdom

🇬🇧

Gartnavel General Hospital, Glasgow, United Kingdom

A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-01-27
Last Posted Date
2024-08-20
Lead Sponsor
Teva Pharmaceuticals USA
Target Recruit Count
80
Registration Number
NCT00830336
Locations
🇺🇸

PRACS Institute Ltd., Fargo, North Dakota, United States

The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-12-17
Last Posted Date
2011-05-19
Lead Sponsor
Pfizer
Target Recruit Count
102
Registration Number
NCT00809328
Locations
🇯🇵

Pfizer Investigational Site, Shiogama-city, Japan

Lipids of the Human Tear Film and Their Effect on Tear Stability

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-12-05
Last Posted Date
2017-12-22
Lead Sponsor
University of Louisville
Target Recruit Count
31
Registration Number
NCT00803452
Locations
🇺🇸

Kentucky Lions Eye Center, Louisville, Kentucky, United States

Partnership for Rapid Elimination of Trachoma

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-11-18
Last Posted Date
2017-07-18
Lead Sponsor
Johns Hopkins University
Target Recruit Count
128
Registration Number
NCT00792922
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

UCSF Proctor Foundation, San Francisco, California, United States

🇬🇧

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

An Open Label Evaluation of the Pharmacokinetics and Safety of Single Dose Intravenous Azithromycin in Preterm Neonates

Phase 1
Completed
Conditions
First Posted Date
2008-09-26
Last Posted Date
2008-09-26
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Target Recruit Count
16
Registration Number
NCT00760279
Locations
🇺🇸

Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

🇺🇸

Wayne State, Detroit, Michigan, United States

Ciprofloxacin Multiple Dose for Adult Cholera

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-08-26
Last Posted Date
2011-07-12
Lead Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Target Recruit Count
218
Registration Number
NCT00741052
Locations
🇧🇩

ICDDR,B, Dhaka, Bangladesh

A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis

First Posted Date
2008-04-01
Last Posted Date
2008-10-21
Lead Sponsor
Pfizer
Target Recruit Count
250
Registration Number
NCT00649831
Locations
🇫🇷

Pfizer Investigational Site, Yerres, France

A Pediatric Taste Test Study of Omnicef Versus Zithromax Antibiotic Suspension Medications

Phase 4
Completed
Conditions
Interventions
First Posted Date
2008-03-27
Last Posted Date
2008-03-27
Lead Sponsor
Abbott
Target Recruit Count
157
Registration Number
NCT00644774
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