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
-

Azithromycin for Preterm Pre-labor Rupture of Membranes

First Posted Date
2019-12-17
Last Posted Date
2024-04-24
Lead Sponsor
Assiut University
Target Recruit Count
300
Registration Number
NCT04202380
Locations
🇪🇬

Women Health Hospital - Assiut university, Assiut, Egypt

Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

First Posted Date
2019-12-04
Last Posted Date
2024-08-05
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
12
Registration Number
NCT04186247
Locations
🇺🇸

UCSF Benioff Children's Hospital, San Francisco, California, United States

🇺🇸

University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States

🇨🇦

IWK Health Centre, Halifax, Canada

and more 2 locations

Azithromycin Reduction to Reach Elimination of Trachoma

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2019-12-04
Last Posted Date
2024-01-19
Lead Sponsor
University of California, San Francisco
Target Recruit Count
100000
Registration Number
NCT04185402
Locations
🇳🇪

Programme National de Santé Oculaire (PNSO), Niamey, Niger

Personalized Treatment Algorithms for Difficult-to-treat Asthma

First Posted Date
2019-11-27
Last Posted Date
2021-08-20
Lead Sponsor
Children's Hospital Medical Center, Cincinnati
Target Recruit Count
21
Registration Number
NCT04179461
Locations
🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

Roflumilast or Azithromycin to Prevent COPD Exacerbations (RELIANCE)

First Posted Date
2019-08-28
Last Posted Date
2024-06-10
Lead Sponsor
Johns Hopkins University
Target Recruit Count
1250
Registration Number
NCT04069312
Locations
🇺🇸

Houston Methodist Hospital, Houston, Texas, United States

🇺🇸

Mount Sinai, New York, New York, United States

🇺🇸

Lenox Hill Hospital/Northwell Health, New York, New York, United States

and more 24 locations

A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

First Posted Date
2019-07-08
Last Posted Date
2024-05-30
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
628
Registration Number
NCT04010539
Locations
🇬🇧

GSK Investigational Site, St Helens, United Kingdom

Zoliflodacin in Uncomplicated Gonorrhoea

First Posted Date
2019-05-22
Last Posted Date
2024-07-26
Lead Sponsor
Global Antibiotics Research and Development Partnership
Target Recruit Count
1011
Registration Number
NCT03959527
Locations
🇺🇸

Public Health - Seattle & King County STD Clinic, Seattle, Washington, United States

🇺🇸

Jefferson County Department of Health, Birmingham, Alabama, United States

🇺🇸

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

and more 14 locations

Azithromycin (AZ) and Sulphadoxine-pyrimethamine (SP) for Malaria Prevention in Pregnant Women (IPT-AZ/IPT-SP)

First Posted Date
2019-05-09
Last Posted Date
2019-05-10
Lead Sponsor
Federal Medical Centre, Owo
Target Recruit Count
168
Registration Number
NCT03944317
Locations
🇳🇬

FMCOWO, Owo, Ondo, Nigeria

Treatment and Vaccine Development of Mycoplasma Pneumoniae

Not Applicable
Conditions
Interventions
First Posted Date
2019-04-11
Last Posted Date
2019-04-11
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
100
Registration Number
NCT03911440
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

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