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
-

the Comparison Efficacy of Azithromycin With Doxycycline in the Treatment of Acne Vulgaris

Phase 2
Conditions
Interventions
First Posted Date
2007-01-09
Last Posted Date
2008-01-29
Lead Sponsor
Shahid Beheshti University of Medical Sciences
Target Recruit Count
100
Registration Number
NCT00419848
Locations
🇮🇷

Shaheed Beheshti Medical University, Skin research center, Tehran, Iran, Islamic Republic of

Bronchiectasis and Long Term Azithromycin Treatment

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-12-22
Last Posted Date
2020-05-28
Lead Sponsor
W.G.Boersma
Target Recruit Count
72
Registration Number
NCT00415350
Locations
🇳🇱

Viecuri MC, Venlo, Netherlands

🇳🇱

U.L.C. Dekkerswald, Groesbeek, Netherlands

🇳🇱

Tergooi Ziekenhuizen, Hilversum, Netherlands

and more 13 locations

Chloroquine Alone or in Combination for Malaria in Children in Malawi

First Posted Date
2006-09-25
Last Posted Date
2014-08-11
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
640
Registration Number
NCT00379821
Locations
🇲🇼

Blantyre Malaria Project - Ndirande Health Centre, Blantyre, Malawi

Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media

Phase 3
Completed
Conditions
First Posted Date
2006-08-03
Last Posted Date
2011-05-17
Lead Sponsor
Pfizer
Target Recruit Count
120
Registration Number
NCT00360100
Locations
🇵🇦

Pfizer Investigational Site, Ciudad de Panama, Panama

Mycoplasma Genitalium Antibiotic Susceptibility and Treatment (MEGA)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2006-07-31
Last Posted Date
2018-08-15
Lead Sponsor
University of Washington
Target Recruit Count
606
Registration Number
NCT00358462
Locations
🇺🇸

Public Health -- Seattle & King County Sexually Transmitted Diseases Clinic located at Harborview Medical Center, Seattle, Washington, United States

Ocular Pharmacokinetics After a Single Drop Instillation of T1225 0.5, 1, 1.5% in 91 Healthy Volunteers

Phase 1
Completed
Conditions
First Posted Date
2006-07-26
Last Posted Date
2006-07-26
Lead Sponsor
Laboratoires Thea
Registration Number
NCT00356850

Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma

Phase 3
Completed
Conditions
First Posted Date
2006-07-26
Last Posted Date
2006-07-26
Lead Sponsor
Laboratoires Thea
Registration Number
NCT00356720

Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Phase 1
Completed
Conditions
First Posted Date
2006-07-26
Last Posted Date
2006-07-26
Lead Sponsor
Laboratoires Thea
Registration Number
NCT00356772

Study of Azithromycin to Prevent Recurrent Trichiasis Following Surgery in Ethiopia

Phase 4
Completed
Conditions
Interventions
First Posted Date
2006-07-04
Last Posted Date
2017-08-07
Lead Sponsor
Johns Hopkins University
Target Recruit Count
1452
Registration Number
NCT00347776
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)

First Posted Date
2006-05-08
Last Posted Date
2019-03-01
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
305
Registration Number
NCT00322465
Locations
🇺🇸

Delgado Personal Health Center, New Orleans, Louisiana, United States

🇺🇸

University of Alabama Hospital - Infectious Diseases, Birmingham, Alabama, United States

🇺🇸

University of North Carolina School of Medicine - Center for Infectious Diseases, Chapel Hill, North Carolina, United States

and more 1 locations
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