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-Prevention in Labor Use Study (A-PLUS)

First Posted Date
2019-03-12
Last Posted Date
2024-10-24
Lead Sponsor
NICHD Global Network for Women's and Children's Health
Target Recruit Count
58747
Registration Number
NCT03871491
Locations
🇨🇩

Kinshasa School of Public Health, Kinshasa, Congo, The Democratic Republic of the

🇧🇩

ICDDRB, Dhaka, Bangladesh

🇬🇹

Institute for Nutrition of Central America and Panama (INCAP), Guatemala City, Guatemala

and more 5 locations

Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

First Posted Date
2019-03-05
Last Posted Date
2023-08-09
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
200
Registration Number
NCT03862495
Locations
🇨🇳

Nanhai Hospital of Southern Medical University, Guangzhou, Guangdong, China

🇨🇳

Dermatology Hospital of Southern Medical Hospital, Guangzhou, Guangdong, China

Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

First Posted Date
2019-02-26
Last Posted Date
2023-06-07
Lead Sponsor
Oxford University Clinical Research Unit, Vietnam
Target Recruit Count
364
Registration Number
NCT03854929
Locations
🇻🇳

Children's Hospital 2, Ho Chi Minh City, Vietnam

Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin

Not Applicable
Conditions
Interventions
First Posted Date
2019-02-05
Last Posted Date
2019-02-05
Lead Sponsor
Cairo University
Target Recruit Count
30
Registration Number
NCT03831269
Locations
🇪🇬

Kasr Alainy Faculty of Medicine Cairo University, Cairo, Egypt

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term

First Posted Date
2019-01-11
Last Posted Date
2024-04-19
Lead Sponsor
University of Oklahoma
Target Recruit Count
186
Registration Number
NCT03801252
Locations
🇺🇸

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Azithromycin Treatment for the Airway Microbiome in Asthma

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2018-11-09
Last Posted Date
2023-08-23
Lead Sponsor
University of Chicago
Target Recruit Count
17
Registration Number
NCT03736629
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

University of Chicago, Chicago, Illinois, United States

Neonates and Azithromycin, an Innovation in the Treatment of Children in Burkina Faso

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-09-24
Last Posted Date
2023-06-27
Lead Sponsor
University of California, San Francisco
Target Recruit Count
21832
Registration Number
NCT03682653
Locations
🇧🇫

Centre de Recherche En Santé de Nouna, Nouna, Burkina Faso

MORDOR II Burkina Faso: Longitudinal Trial

First Posted Date
2018-09-19
Last Posted Date
2023-08-09
Lead Sponsor
University of California, San Francisco
Target Recruit Count
500
Registration Number
NCT03676751
Locations
🇧🇫

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

Community Health Azithromycin Trial in Burkina Faso

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-09-19
Last Posted Date
2023-12-05
Lead Sponsor
University of California, San Francisco
Target Recruit Count
68246
Registration Number
NCT03676764
Locations
🇧🇫

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

Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

First Posted Date
2018-09-14
Last Posted Date
2024-12-04
Lead Sponsor
Kevin Winthrop
Target Recruit Count
474
Registration Number
NCT03672630
Locations
🇺🇸

Loma Linda University Medical Center, Loma Linda, California, United States

🇺🇸

University of California, San Diego, San Diego, California, United States

🇺🇸

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

and more 23 locations
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