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
-

Single Dose Azithromycin to Prevent Cholera in Children

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2020-03-30
Last Posted Date
2022-05-31
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
920
Registration Number
NCT04326478
Locations
🇧🇩

icddr,b Dhaka hospital, Dhaka, Bangladesh

Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19

First Posted Date
2020-03-26
Last Posted Date
2021-06-29
Lead Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Target Recruit Count
117
Registration Number
NCT04322396
Locations
🇩🇰

Aalborg Sygehus, Aalborg, Denmark

🇩🇰

Herlev-Gentofte Hospital, Copenhagen, Denmark

🇩🇰

Odense Universitetshospital, Odense, Denmark

and more 5 locations

Anti-viral Effects of Azithromycin in Patients With Asthma and COPD

First Posted Date
2020-03-24
Last Posted Date
2021-07-26
Lead Sponsor
Bispebjerg Hospital
Target Recruit Count
100
Registration Number
NCT04319705
Locations
🇩🇰

University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark

Gut and Azithromycin Mechanisms in Infants and Children II

Phase 4
Completed
Conditions
Interventions
First Posted Date
2020-03-19
Last Posted Date
2023-06-29
Lead Sponsor
University of California, San Francisco
Target Recruit Count
449
Registration Number
NCT04315272
Locations
🇧🇫

Centre de Recherche en santé de nouna, Nouna, Boucle Du Mouhoun, Burkina Faso

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

First Posted Date
2020-03-17
Last Posted Date
2024-12-11
Lead Sponsor
The University of Queensland
Target Recruit Count
300
Registration Number
NCT04310930
Locations
🇦🇺

St George Hospital, Kogarah, New South Wales, Australia

🇦🇺

Austin Hospital, Heidelberg, Victoria, Australia

🇦🇺

Royal Melbourne Hospital, Parkville, Victoria, Australia

and more 47 locations

A Study of Standard Drugs for Mycobacterium Avium Complex

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2020-02-27
Last Posted Date
2024-07-16
Lead Sponsor
Johns Hopkins University
Target Recruit Count
30
Registration Number
NCT04287049
Locations
🇺🇸

Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

The Effect of Preoperative Antibiotics on Peri-implant Healing

First Posted Date
2020-02-21
Last Posted Date
2022-09-07
Lead Sponsor
Université de Montréal
Target Recruit Count
50
Registration Number
NCT04280406
Locations
🇨🇦

Université de Montréal - Faculty of Dentistry - Dental clinics, Montreal, Quebec, Canada

Improving Care Through Azithromycin Research for Infants in Africa

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2020-01-22
Last Posted Date
2024-05-31
Lead Sponsor
Barcelona Institute for Global Health
Target Recruit Count
20560
Registration Number
NCT04235816
Locations
🇸🇱

College of Medicine and Allied Health Sciences, Freetown, Sierra Leone

Azithromycin for Child Survival in Niger: Mortality and Resistance Trial

First Posted Date
2020-01-13
Last Posted Date
2024-01-05
Lead Sponsor
University of California, San Francisco
Target Recruit Count
1106050
Registration Number
NCT04224987
Locations
🇳🇪

Programme national de santé oculaire, Niamey, Niger

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