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
-

Drug Use Investigation On Zithromac (Azithromycin) In HIV Patients

Completed
Conditions
Interventions
First Posted Date
2010-10-25
Last Posted Date
2013-04-26
Lead Sponsor
Pfizer
Target Recruit Count
476
Registration Number
NCT01227395

Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.

Not Applicable
Conditions
Interventions
First Posted Date
2010-10-20
Last Posted Date
2018-07-13
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Target Recruit Count
20
Registration Number
NCT01224977
Locations
🇧🇪

University Hospital of Leuven, Leuven, Vlaams-Brabant, Belgium

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

First Posted Date
2010-10-08
Last Posted Date
2010-10-08
Lead Sponsor
Chongqing Medical University
Target Recruit Count
47
Registration Number
NCT01217099

The Effect of Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2010-08-10
Last Posted Date
2010-10-27
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
42
Registration Number
NCT01178762
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Absorption of Drugs Post-Bariatric Surgery (Absorb-Azithromycin)

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2010-07-01
Last Posted Date
2011-07-29
Lead Sponsor
University of Alberta
Target Recruit Count
30
Registration Number
NCT01154569
Locations
🇨🇦

University of Alberta Hospital, Edmonton, Alberta, Canada

Chlamydia Trachomatis Immunology and Vaccinology Study

Completed
Conditions
Interventions
First Posted Date
2010-06-28
Last Posted Date
2015-12-03
Lead Sponsor
Harold Wiesenfeld
Target Recruit Count
347
Registration Number
NCT01150747
Locations
🇺🇸

Mercy Hospital of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

🇺🇸

Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

and more 1 locations

A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2010-04-13
Last Posted Date
2012-06-11
Lead Sponsor
Alcon Research
Target Recruit Count
122
Registration Number
NCT01102244
Locations
🇺🇸

Ora, Andover, Massachusetts, United States

Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

Phase 2
Completed
Conditions
Interventions
First Posted Date
2010-03-18
Last Posted Date
2014-11-04
Lead Sponsor
Laboratoires Thea
Target Recruit Count
93
Registration Number
NCT01089608
Locations
🇫🇷

C.H.N.O des XV-XX, Paris, France

The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough

First Posted Date
2010-02-19
Last Posted Date
2015-09-18
Lead Sponsor
Isala
Target Recruit Count
84
Registration Number
NCT01071161
Locations
🇳🇱

Isala Klinieken, Zwolle, Ov, Netherlands

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