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
-

Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

First Posted Date
2016-07-21
Last Posted Date
2016-09-27
Lead Sponsor
University of Chile
Target Recruit Count
54
Registration Number
NCT02839408
Locations
🇨🇱

Faculty of Dentistry of University of Chile, Santiago, Chile

Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years

Completed
Conditions
Interventions
First Posted Date
2016-06-17
Last Posted Date
2016-06-17
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
2055
Registration Number
NCT02803944
Locations
🇫🇷

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud, 165 Chemin du Grand Revoyet, Pierre-Bénite, France

Azithromycin - Ivermectin Mass Drug Administration for Skin Disease

First Posted Date
2016-05-17
Last Posted Date
2019-09-17
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
1291
Registration Number
NCT02775617
Locations
🇸🇧

Atoifi Adventist Hospital, Atoifi, Malaita, Solomon Islands

Nepal Undifferentiated Febrile Illness Trial

First Posted Date
2016-05-16
Last Posted Date
2023-12-06
Lead Sponsor
Oxford University Clinical Research Unit, Vietnam
Target Recruit Count
330
Registration Number
NCT02773407
Locations
🇳🇵

Nepal Civil Service Hospital, Kathmandu, Nepal

🇳🇵

Patan Hospital, Kathmandu, Nepal

A Randomized Controlled Trial of Three Antibiotic Regimens for First Trimester Abortions

First Posted Date
2016-04-29
Last Posted Date
2022-02-11
Lead Sponsor
Medstar Health Research Institute
Target Recruit Count
181
Registration Number
NCT02756403
Locations
🇺🇸

MedStar Washington Hospital Center, Washington, District of Columbia, United States

🇺🇸

Planned Parenthood Metropolitan Washington, Silver Spring, Maryland, United States

Sanitation, Water, and Instruction in Face-washing for Trachoma I/II

First Posted Date
2016-04-28
Last Posted Date
2023-08-21
Lead Sponsor
University of California, San Francisco
Target Recruit Count
340000
Registration Number
NCT02754583
Locations
🇪🇹

The Carter Center Ethiopia, Addis Ababa, Ethiopia

Cefixime / Azithromycin pK Study

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-03-15
Last Posted Date
2017-09-15
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
10
Registration Number
NCT02708992
Locations
🇺🇸

Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit, Durham, North Carolina, United States

Microbial, Immune, and Metabolic Perturbations by Antibiotics (MIME Study)

First Posted Date
2016-03-14
Last Posted Date
2024-12-12
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
210
Registration Number
NCT02707042
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF)

First Posted Date
2016-02-09
Last Posted Date
2021-06-28
Lead Sponsor
Seattle Children's Hospital
Target Recruit Count
119
Registration Number
NCT02677701
Locations
🇺🇸

Children's Hospital of Los Angeles, Los Angeles, California, United States

🇺🇸

University Hospitals Case Medical Center/Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

🇺🇸

The Nemours Children's Clinic - Orlando, Orlando, Florida, United States

and more 36 locations

A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2015-12-15
Last Posted Date
2018-06-21
Lead Sponsor
University of Mississippi Medical Center
Registration Number
NCT02630394
Locations
🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

🇺🇸

Vanderbilt University, Nashville, Tennessee, United States

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