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
-

Mortality Reduction After Oral Azithromycin: Mortality Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-01-29
Last Posted Date
2022-11-08
Lead Sponsor
University of California, San Francisco
Target Recruit Count
190238
Registration Number
NCT02047981
Locations
🇲🇼

College of Medicine at the University of Malawi, Blantyre, Blantyre, Malawi

🇬🇧

London School of Hygiene & Tropical Medicine, London, United Kingdom

🇳🇪

The Carter Center, Niger, Niamey, Niger

and more 3 locations

Mortality Reduction After Oral Azithromycin: Morbidity Study

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-01-29
Last Posted Date
2021-03-17
Lead Sponsor
University of California, San Francisco
Target Recruit Count
72000
Registration Number
NCT02048007
Locations
🇺🇸

UCSF Proctor Foundation, San Francisco, California, United States

🇹🇿

Kongwa Trachoma Project, Kongwa, Tanzania

🇳🇪

The Carter Center, Niger, Niamey, Niger

and more 3 locations

Phase II Investigation of Antimycobacterial Therapy on Progressive, Pulmonary Sarcoidosis

First Posted Date
2013-12-31
Last Posted Date
2020-07-09
Lead Sponsor
Vanderbilt University
Target Recruit Count
97
Registration Number
NCT02024555
Locations
🇺🇸

Ohio State University, Columbus, Ohio, United States

🇺🇸

Cleveland Clinic, Cleveland, Ohio, United States

🇺🇸

Vanderbilt University School of Medicine, Nashville, Tennessee, United States

and more 3 locations

Azithromycin for Children Hospitalized With Asthma

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2013-12-06
Last Posted Date
2020-08-13
Lead Sponsor
Montefiore Medical Center
Target Recruit Count
159
Registration Number
NCT02003911
Locations
🇺🇸

The Children's Hospital at Montefiore, Bronx, New York, United States

Efficacy of Azithromycin to Prevent Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation

First Posted Date
2013-10-09
Last Posted Date
2020-01-07
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
480
Registration Number
NCT01959100
Locations
🇫🇷

Saint Louis, Paris, Ile De France, France

Effect of WHO-yaws Elimination Strategy in Lihir Island, Papua New Guinea

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-10-07
Last Posted Date
2017-08-28
Lead Sponsor
Lihir Medical Centre
Target Recruit Count
16000
Registration Number
NCT01955252
Locations
🇵🇬

Lihir Medical Centre, Londolovit, New ireland province, Papua New Guinea

The Effect of Azithromycin in the Treatment of Chronic Periodontitis

First Posted Date
2013-08-13
Last Posted Date
2013-08-13
Lead Sponsor
Isfahan University of Medical Sciences
Target Recruit Count
80
Registration Number
NCT01921738
Locations
🇮🇷

School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran, Islamic Republic of

PASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2013-08-09
Last Posted Date
2016-08-05
Lead Sponsor
Pfizer
Target Recruit Count
8
Registration Number
NCT01919996
Locations
🇺🇸

Infant Welfare Society of Chicago, Chicago, Illinois, United States

🇺🇸

Martel Eye Medical Group, Rancho Cordova, California, United States

🇺🇸

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

and more 3 locations

Peri-operative Azithromycin to Improve Early Allograft Function and Outcome After Lung Transplantation

First Posted Date
2013-08-02
Last Posted Date
2015-11-11
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
70
Registration Number
NCT01915082
Locations
🇧🇪

University Hospitals Leuven, Leuven, Belgium

Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis

First Posted Date
2013-07-19
Last Posted Date
2014-05-22
Lead Sponsor
Emory University
Registration Number
NCT01903057
Locations
🇲🇿

National Institute of Health, Ministry of Health, Maputo, Mozambique

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