MedPath

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 Level in Tears and in Conjunctiva in 36 Healthy Volunteers

Phase 1
Completed
Conditions
Eye Infections, Bacterial
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
Trichiasis
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)

Phase 2
Completed
Conditions
Urethritis
Interventions
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

Trial II of Lung Protection With Azithromycin in the Preterm Infant

Phase 2
Completed
Conditions
Bronchopulmonary Dysplasia
Interventions
Drug: Placebo
Drug: Azithromycin
First Posted Date
2006-04-27
Last Posted Date
2018-06-27
Lead Sponsor
Hubert Ballard
Target Recruit Count
220
Registration Number
NCT00319956
Locations
🇺🇸

University of Kentucky Medical Center, Lexington, Kentucky, United States

Intrapulmonary Pharmacokinetics of Antibiotics

Phase 4
Terminated
Conditions
Healthy
First Posted Date
2006-04-18
Last Posted Date
2009-02-13
Lead Sponsor
University of Illinois at Chicago
Target Recruit Count
35
Registration Number
NCT00315601
Locations
🇺🇸

Pulmonary Associates PA, Phoenix, Arizona, United States

TELI COM - Telithromycin in Children With Otitis Media

Phase 3
Terminated
Conditions
Otitis Media, Suppurative
Otitis Media, Purulent
First Posted Date
2006-04-17
Last Posted Date
2009-04-03
Lead Sponsor
Sanofi
Target Recruit Count
1500
Registration Number
NCT00315003
Locations
🇵🇪

Sanofi-Aventis, Lima, Peru

Azithromycin Combination Therapy for Malaria

Phase 2
Completed
Conditions
Plasmodium Falciparum Malaria
First Posted Date
2006-03-06
Last Posted Date
2010-08-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
120
Registration Number
NCT00299208
Locations
🇹🇭

Mahidol University Hospital for Tropical Diseases, Bangkok, Thailand

Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex

Phase 2
Conditions
Cystic Fibrosis
Interventions
Drug: Placebo
Drug: Azithromycin
First Posted Date
2006-03-03
Last Posted Date
2009-07-31
Lead Sponsor
Unity Health Toronto
Target Recruit Count
45
Registration Number
NCT00298922
Locations
🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

Not Applicable
Completed
Conditions
Malaria
First Posted Date
2006-02-06
Last Posted Date
2006-02-06
Lead Sponsor
University of North Carolina
Target Recruit Count
141
Registration Number
NCT00287300
Locations
🇲🇼

Mpemba and Madziabango Health Centers, Blantyre, Malawi

Azithromycin in Control of Trachoma II

Phase 4
Withdrawn
Conditions
Trachoma
Interventions
First Posted Date
2006-02-02
Last Posted Date
2012-04-16
Lead Sponsor
University of California, San Francisco
Registration Number
NCT00286026
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

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