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
-

Tebipenem Trial in Children With Shigellosis

Phase 2
Recruiting
Conditions
Shigellosis
Interventions
First Posted Date
2021-11-16
Last Posted Date
2024-07-15
Lead Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Target Recruit Count
162
Registration Number
NCT05121974
Locations
🇧🇩

International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh

International Milk Composition (IMiC) Consortium

Active, not recruiting
Conditions
Infant Growth
Maternal Health
Infant Nutrition
Interventions
Dietary Supplement: Vitamin B3
Biological: Azithromycin
Dietary Supplement: Fortified food supplement
First Posted Date
2021-11-15
Last Posted Date
2024-12-05
Lead Sponsor
University of Manitoba
Target Recruit Count
1000
Registration Number
NCT05119166
Locations
🇨🇦

Manitoba Interdisciplinary Lactation Centre (MILC), Winnipeg, Manitoba, Canada

Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea

Phase 4
Completed
Conditions
Neisseria Gonorrhoeae
Interventions
First Posted Date
2021-08-30
Last Posted Date
2024-08-02
Lead Sponsor
Institute of Tropical Medicine, Belgium
Target Recruit Count
42
Registration Number
NCT05027516
Locations
🇧🇪

Institute of Tropical Medicine, Antwerpen, Belgium

Hypertonic Saline for MAC

Phase 4
Recruiting
Conditions
Nontuberculous Mycobacterial Lung Disease
Nontuberculous Mycobacterium Infection
Interventions
First Posted Date
2021-06-10
Last Posted Date
2023-12-19
Lead Sponsor
Oregon Health and Science University
Target Recruit Count
50
Registration Number
NCT04921943
Locations
🇺🇸

NYU Langone Health, New York, New York, United States

🇨🇦

University Health Network, Toronto, Ontario, Canada

🇺🇸

Oregon Health & Science University, Portland, Oregon, United States

Experimental Human Infection With Neisseria Gonorrhoeae (LptA Trial)

Phase 1
Completed
Conditions
Gonococcal Infection
Interventions
Drug: Azithromycin
Drug: Ceftriaxone
Drug: Ciprofloxacin
Biological: Neisseria gonorrhoeae strain FA1090 A26
Biological: Neisseria gonorrhoeae strain FA7527
First Posted Date
2021-05-03
Last Posted Date
2021-12-02
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
16
Registration Number
NCT04870138
Locations
🇺🇸

University of North Carolina Health Care - Infectious Diseases, Chapel Hill, North Carolina, United States

EAT-DUTA AndroCoV Trial

Phase 2
Completed
Conditions
Covid19
Interventions
First Posted Date
2021-01-28
Last Posted Date
2021-01-28
Lead Sponsor
Corpometria Institute
Target Recruit Count
138
Registration Number
NCT04729491
Locations
🇧🇷

Corpometria Institute, Brasília, DF, Brazil

Infant Mortality Reduction by the Mass Administration of Azithromycin

Phase 4
Recruiting
Conditions
Child Mortality
Interventions
Drug: Placebo
Drug: Azithromycin
First Posted Date
2021-01-20
Last Posted Date
2023-06-13
Lead Sponsor
University of California, San Francisco
Target Recruit Count
694400
Registration Number
NCT04716712
Locations
🇧🇫

Helen Keller International, Ouagadougou, Burkina Faso

🇺🇸

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

🇧🇫

Centre de Recherche en Sante de Nouna, Nouna, Burkina Faso

The Effect of Azithromycin Use on Conduction System of Heart in COVID-19 Positive Children

Completed
Conditions
Azithromycin Adverse Reaction
Covid19
Long QT Syndrome
Interventions
First Posted Date
2021-01-07
Last Posted Date
2021-01-07
Lead Sponsor
Kayseri City Hospital
Target Recruit Count
105
Registration Number
NCT04699097
Locations
🇹🇷

Süleyman Sunkak, Kayseri, In The USA Or Canada, Please Select..., Turkey

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Phase 3
Completed
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
First Posted Date
2020-12-21
Last Posted Date
2024-06-28
Lead Sponsor
Insmed Incorporated
Target Recruit Count
99
Registration Number
NCT04677543
Locations
🇪🇸

ESP002, Barcelona, Spain

🇪🇸

ESP004, Madrid, Spain

🇪🇸

ESP003, Barcelona, Spain

and more 59 locations

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Phase 3
Active, not recruiting
Conditions
Mycobacterium Infections, Nontuberculous
Interventions
Drug: ALIS
Drug: Azithromycin
Drug: Ethambutol
Drug: ELC (matching placebo for ALIS)
First Posted Date
2020-12-21
Last Posted Date
2024-12-24
Lead Sponsor
Insmed Incorporated
Target Recruit Count
425
Registration Number
NCT04677569
Locations
🇺🇸

USA014, Saint Petersburg, Florida, United States

🇺🇸

USA084, Sebastian, Florida, United States

🇺🇸

USA067, Tampa, Florida, United States

and more 159 locations
© Copyright 2025. All Rights Reserved by MedPath