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
-

PK PD Study of IDA and Azithromycin for NTDs ( ComboNTDs )

First Posted Date
2018-09-10
Last Posted Date
2019-02-28
Lead Sponsor
Lihir Medical Centre
Target Recruit Count
42
Registration Number
NCT03664063
Locations
🇵🇬

Lihir Medical Centre, Londolovit, New Ireland Province, Papua New Guinea

Efficacy of Azithromycin as an Adjunct to Non-Surgical Periodontal Treatment

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2018-08-14
Last Posted Date
2022-09-09
Lead Sponsor
Universidad Nacional Andres Bello
Target Recruit Count
18
Registration Number
NCT03629288
Locations
🇨🇱

Universidad Nacional Andres Bello, Viña Del Mar, Valparaíso, Chile

Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

First Posted Date
2018-08-01
Last Posted Date
2021-01-07
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
177
Registration Number
NCT03608774
Locations
🇺🇸

University of Washington - Harborview Medical Center - Center for AIDS and STD, Seattle, Washington, United States

🇺🇸

Fenway Health - The Fenway Institute, Boston, Massachusetts, United States

Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)

First Posted Date
2018-06-26
Last Posted Date
2022-09-01
Lead Sponsor
University of California, San Francisco
Target Recruit Count
301
Registration Number
NCT03568643
Locations
🇧🇫

Centre de Recherche en santé de nouna, Nouna, Boucle Du Mouhoun, Burkina Faso

Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial

First Posted Date
2018-06-21
Last Posted Date
2021-01-26
Lead Sponsor
Vital Pakistan Trust
Target Recruit Count
957
Registration Number
NCT03564652
Locations
🇵🇰

Peri-urban slums of Karachi (Rehri Goth, Bhains Colony and Ali Akber Shah Goth), Karachi, Sindh, Pakistan

Accuracy and Consequences of Using Trial-of-antibiotics for TB Diagnosis (ACT-TB Study)

First Posted Date
2018-06-04
Last Posted Date
2021-04-28
Lead Sponsor
London School of Hygiene and Tropical Medicine
Target Recruit Count
1583
Registration Number
NCT03545373
Locations
🇲🇼

University of Malawi College of Medicine, Blantyre, Southern, Malawi

Azithromycin Compared With Doxycycline for Treating Anorectal Chlamydia Trachomatis Infection Concomitant to a Vaginal Infection

First Posted Date
2018-05-22
Last Posted Date
2018-06-04
Lead Sponsor
University Hospital, Bordeaux
Target Recruit Count
460
Registration Number
NCT03532464
Locations
🇫🇷

CeGIDD - Marseille, Marseille, Marignane, France

🇫🇷

Hôpital Hôtel Dieu, Paris, France

🇫🇷

CeGGID - Bordeaux, Bordeaux, France

and more 4 locations

Treatment of Macrolide-resistant Mycoplasma Pneumoniae

First Posted Date
2018-05-21
Last Posted Date
2021-07-28
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
100
Registration Number
NCT03530319
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Addition of Azithromycin to Cefazolin Will Reduce Post CS Infections More Than Cefazolin Only.

Phase 1
Conditions
Interventions
First Posted Date
2018-04-18
Last Posted Date
2018-04-18
Lead Sponsor
Ain Shams University
Target Recruit Count
400
Registration Number
NCT03502356
Locations
🇪🇬

Ain Shams, Cairo, Elabasy, Egypt

© Copyright 2024. All Rights Reserved by MedPath