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
-

A Bioequivalence Study of Two Azithromycin Tablet Formulations in Indonesian Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-05-18
Last Posted Date
2012-05-21
Lead Sponsor
PT Novell Pharmaceutical Laboratories
Target Recruit Count
24
Registration Number
NCT01602055
Locations
🇮🇩

PT Clinisindo Laboratories, Jakarta, Indonesia

Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis

First Posted Date
2012-03-22
Last Posted Date
2021-03-17
Lead Sponsor
Southern California Institute for Research and Education
Target Recruit Count
100
Registration Number
NCT01560962
Locations
🇺🇸

Veterans Affairs Long Beach Healthcare System, Long Beach, California, United States

Erythromycin Versus Azithromycin in Preterm Premature Rupture of Membranes

First Posted Date
2012-03-16
Last Posted Date
2024-10-14
Lead Sponsor
Indiana University
Registration Number
NCT01556334
Locations
🇺🇸

Indiana University School of Medicine, Indianapolis, Indiana, United States

Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

First Posted Date
2012-02-10
Last Posted Date
2014-07-04
Lead Sponsor
University of Aarhus
Target Recruit Count
100
Registration Number
NCT01531218
Locations
🇩🇰

Department of Infectious Diseases, Aalborg Hospital, Aalborg, Denmark

Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2011-12-06
Last Posted Date
2017-06-14
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
40
Registration Number
NCT01486758
Locations
🇺🇸

Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital, Saint Louis, Missouri, United States

The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Completed
Conditions
Interventions
First Posted Date
2011-11-04
Last Posted Date
2017-05-11
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
30
Registration Number
NCT01464840
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Fosmidomycin and Azithromycin for Acute Uncomplicated Plasmodium Falciparum Malaria (P. Malaria) in Adults

Phase 2
Conditions
Interventions
First Posted Date
2011-11-03
Last Posted Date
2011-11-03
Lead Sponsor
Jomaa Pharma GmbH
Target Recruit Count
43
Registration Number
NCT01464125
Locations
🇹🇭

Mahidol University, Bangkok, Thailand

Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2011-11-01
Last Posted Date
2023-09-29
Lead Sponsor
Instituto de Investigacion Sanitaria La Fe
Target Recruit Count
30
Registration Number
NCT01463371
Locations
🇪🇸

University Hospital La Fe, Valencia, Spain

Effect of Azithromycin on Oesophageal Hypomotility

First Posted Date
2011-10-07
Last Posted Date
2015-04-22
Lead Sponsor
JAFAR JAFARI
Target Recruit Count
26
Registration Number
NCT01448993
Locations
🇬🇧

Royal London Hospital, London, United Kingdom

AZithromycin Against pLacebo in Exacerbations of Asthma

Phase 4
Completed
Conditions
Interventions
First Posted Date
2011-09-30
Last Posted Date
2024-01-10
Lead Sponsor
Imperial College London
Target Recruit Count
199
Registration Number
NCT01444469
Locations
🇬🇧

Barnsley Hospital NHS Foundation, Barnsley, England, United Kingdom

🇬🇧

Countess of Chester Hospital NHS Foundation Trust, Liverpool, England, United Kingdom

🇬🇧

Surrey & Sussex Healthcare NHS Trust, Redhill, England, United Kingdom

and more 11 locations
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