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
-

BACE Trial Substudy 1 - PROactive Substudy

First Posted Date
2014-07-31
Last Posted Date
2020-04-08
Lead Sponsor
Wim Janssens
Target Recruit Count
60
Registration Number
NCT02205242
Locations
🇧🇪

ZNA Middelheim, Antwerpen, Vlaanderen, Belgium

🇧🇪

UZ Gent, Gent, Vlaanderen, Belgium

🇧🇪

Jessa Ziekenhuis, Hasselt, Vlaanderen, Belgium

and more 3 locations

BACE Trial Substudy 2 - FarmEc Substudy

First Posted Date
2014-07-31
Last Posted Date
2020-04-08
Lead Sponsor
Wim Janssens
Target Recruit Count
350
Registration Number
NCT02205255
Locations
🇧🇪

UZ Brussel, Brussel, Brussel Hoofdstedelijk Gewest, Belgium

🇧🇪

Jessa Ziekenhuis, Hasselt, Vlaanderen, Belgium

🇧🇪

AZ Groeninge Ziekenhuis, Kortrijk, Vlaanderen, Belgium

and more 17 locations

An Open Label Trial of Azithromycin in Chronic Productive Cough

Phase 3
Conditions
Interventions
First Posted Date
2014-07-22
Last Posted Date
2016-02-18
Lead Sponsor
University of Nottingham
Target Recruit Count
50
Registration Number
NCT02196493
Locations
🇬🇧

Respiratory Research Unit, Nottingham, Nottinghamshire, United Kingdom

Nepal Elimination of Trachoma Study

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2014-06-26
Last Posted Date
2015-05-21
Lead Sponsor
University of California, San Francisco
Registration Number
NCT02176057
Locations
🇳🇵

Geta Eye Hospital, Geta, Kailali, Nepal

Azithromycin in Idiopathic Pulmonary Fibrosis

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2014-06-24
Last Posted Date
2019-08-28
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Target Recruit Count
27
Registration Number
NCT02173145
Locations
🇨🇭

University Hospital for Pulmonology, Berne, Switzerland

🇨🇭

Kantonsspital St. Gallen, St. Gallen, Switzerland

🇨🇭

Universitätsspital Basel, Basel, Switzerland

and more 1 locations

Azithromycin for Acute Exacerbations Requiring Hospitalization

First Posted Date
2014-05-09
Last Posted Date
2018-09-05
Lead Sponsor
Wim Janssens
Target Recruit Count
301
Registration Number
NCT02135354
Locations
🇧🇪

Jessa Ziekenhuis, Hasselt, Vlaanderen, Belgium

🇧🇪

Grand Hôpital de Charleroi, Gilly, Wallonië, Belgium

🇧🇪

St. Augustinus Ziekenhuis, Antwerpen, Vlaanderen, Belgium

and more 17 locations

Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection

First Posted Date
2014-04-29
Last Posted Date
2014-04-29
Lead Sponsor
Centro Universitario de Lavras
Target Recruit Count
77
Registration Number
NCT02126267
Locations
🇧🇷

Douglas Campideli Fonseca, Lavras, Minas Gerais, Brazil

Efficacy of Azithromycin in Treatment of Bronchiectasis

First Posted Date
2014-04-08
Last Posted Date
2014-07-18
Lead Sponsor
Penang Hospital, Malaysia
Target Recruit Count
78
Registration Number
NCT02107274
Locations
🇲🇾

Respiratory Unit, Taiping Hospital, Taiping, Perak, Malaysia

OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

First Posted Date
2014-02-04
Last Posted Date
2019-10-01
Lead Sponsor
Bonnie Ramsey
Target Recruit Count
221
Registration Number
NCT02054156
Locations
🇺🇸

Childrens Hospital Los Angeles, Los Angeles, California, United States

🇺🇸

CFF Care Center & Pediatric Program Emory University, Atlanta, Georgia, United States

🇺🇸

CFF Affiliate Program Children's Healthcare of Atlanta, Atlanta, Georgia, United States

and more 42 locations
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