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 in the Prevention of Lung Injury in Premature Newborn

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-04-02
Last Posted Date
2018-04-02
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
80
Registration Number
NCT03485703

Placebo-Controlled Trial of Antibiotic Therapy in Adults With Suspect Lower Respiratory Tract Infection (LRTI) and a Procalcitonin Level

First Posted Date
2017-11-14
Last Posted Date
2023-06-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
514
Registration Number
NCT03341273
Locations
🇺🇸

The Hope Clinic of Emory University, Atlanta, Georgia, United States

🇺🇸

Atlanta VA Medical Center - Infectious Diseases Clinic, Decatur, Georgia, United States

🇺🇸

Texas Medical Center - Michael E. DeBakey Veterans Affairs, Houston, Texas, United States

and more 2 locations

Mortality Reduction After Oral Azithromycin Contingency: Mortality Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2017-11-09
Last Posted Date
2022-08-11
Lead Sponsor
University of California, San Francisco
Target Recruit Count
66228
Registration Number
NCT03338244
Locations
🇳🇪

The Carter Center, Niamey, Niger

🇺🇸

UCSF Proctor Foundation, San Francisco, California, United States

Kebele Elimination of Trachoma for Ocular Health

Phase 4
Recruiting
Conditions
Interventions
First Posted Date
2017-11-07
Last Posted Date
2024-03-08
Lead Sponsor
University of California, San Francisco
Target Recruit Count
320000
Registration Number
NCT03335072
Locations
🇺🇸

UCSF Proctor Foundation, San Francisco, California, United States

🇪🇹

Eyu-Ethiopia, Bahir Dar, Ethiopia

Effect of Antibiotics on Gut Microbiome and Plasma Metabolome

First Posted Date
2017-09-06
Last Posted Date
2018-04-04
Lead Sponsor
Finnish Institute for Health and Welfare
Target Recruit Count
39
Registration Number
NCT03273296
Locations
🇫🇮

National Institute for Health and Welfare, Helsinki, Finland

YCFM (Youth Correctional Facilities Males)

Phase 2
Completed
Conditions
Interventions
First Posted Date
2017-08-15
Last Posted Date
2019-10-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
100
Registration Number
NCT03249935
Locations
🇺🇸

Los Angeles County Department of Health Services - Juvenile Court Health Services, Los Angeles, California, United States

Antibiotic Prophlaxis for High-risk Laboring Women in Low Income Countries

First Posted Date
2017-08-14
Last Posted Date
2022-07-18
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
756
Registration Number
NCT03248297
Locations
🇨🇲

Cameroon Baptist Convention Health Services, Bamenda, Cameroon

Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death

Phase 3
Completed
Conditions
Interventions
First Posted Date
2017-06-27
Last Posted Date
2022-03-31
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
11985
Registration Number
NCT03199547
Locations
🇬🇲

Medical Research Council Unit The Gambia, Banjul, Gambia

🇧🇫

Clinical Research Unit of Nanoro, Nanoro, Burkina Faso

Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso

First Posted Date
2017-06-15
Last Posted Date
2023-03-02
Lead Sponsor
University of California, San Francisco
Target Recruit Count
252
Registration Number
NCT03187834
Locations
🇺🇸

UCSF Proctor Foundation, San Francisco, California, United States

🇧🇫

Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso

Effect of Topical Azithromycin on Tear Film Thickness in Patients With Meibomian Gland Dysfunction

First Posted Date
2017-05-22
Last Posted Date
2022-04-07
Lead Sponsor
Medical University of Vienna
Target Recruit Count
80
Registration Number
NCT03162497
Locations
🇦🇹

Gerhard Garhofer, Vienna, Austria

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