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 Therapy in Preschoolers with a Severe Wheezing Episode Diagnosed At the Emergency Department

Phase 3
Active, not recruiting
Conditions
Wheezing
Asthma
Interventions
Drug: Placebo
Drug: Azithromycin
First Posted Date
2020-12-16
Last Posted Date
2024-12-16
Lead Sponsor
University of Arizona
Target Recruit Count
1476
Registration Number
NCT04669288
Locations
🇺🇸

Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, United States

🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

🇺🇸

Children's Hospital of New York Medical Center, New York, New York, United States

and more 5 locations

Clarithromycin Versus Azithromycin in Treatment of Mild COVID-19 Infection

Not Applicable
Completed
Conditions
Covid19
Interventions
First Posted Date
2020-11-10
Last Posted Date
2020-11-10
Lead Sponsor
South Valley University
Target Recruit Count
300
Registration Number
NCT04622891
Locations
🇪🇬

south-Vally University faculty of medicine, Qena, Egypt

Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire

Not Applicable
Completed
Conditions
Azithromycin
Child Mortality
Interventions
First Posted Date
2020-11-05
Last Posted Date
2021-07-20
Lead Sponsor
FHI 360
Target Recruit Count
1735
Registration Number
NCT04617626
Locations
🇨🇮

Boundiali Health District, Boundiali, Savanes Region, Côte D'Ivoire

Efficacy and Safety of Favipiravir in Covid-19 Patients in Indonesia

Phase 3
Completed
Conditions
Covid19
Infectious Disease
SARS-CoV Infection
Interventions
First Posted Date
2020-11-03
Last Posted Date
2023-03-08
Lead Sponsor
Ina-Respond
Target Recruit Count
130
Registration Number
NCT04613271
Locations
🇮🇩

RSPI Sulianti Saroso, Jakarta, DKI Jakarta, Indonesia

🇮🇩

RSJ Soerodjo, Magelang, Central Java, Indonesia

🇮🇩

RSUP Dr. Kariadi, Semarang, Central Of Java, Indonesia

Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Phase 1
Withdrawn
Conditions
Covid19
SARS (Severe Acute Respiratory Syndrome)
Interventions
Drug: Hydroxychloroquine
Dietary Supplement: Vitamins and Minerals
Drug: Azithromycin
First Posted Date
2020-10-19
Last Posted Date
2021-12-07
Lead Sponsor
International Brain Research Foundation
Registration Number
NCT04590274

Evaluation of the Efficacy and Safety of Treatments for Patients Hospitalized for COVID-19 Infection Without Signs of Acute Respiratory Failure, in Tunisia

Phase 3
Withdrawn
Conditions
COVID 19
Patients Hospitalized
Interventions
Drug: HCQ
Drug: Azithromycin
Drug: Doxycycline
Dietary Supplement: Zinc
First Posted Date
2020-08-27
Last Posted Date
2020-08-27
Lead Sponsor
Abderrahmane Mami Hospital
Registration Number
NCT04528927
Locations
🇹🇳

Eshmoun Clinical Research Centre, Tunis, Tunisia

Eosinophil-guided Reduction of Inhaled Corticosteroids

Phase 4
Recruiting
Conditions
COPD
Inhaled Corticosteroid
COPD Exacerbation
Azithromycin
Pneumonia
Interventions
First Posted Date
2020-07-22
Last Posted Date
2024-03-05
Lead Sponsor
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
Target Recruit Count
444
Registration Number
NCT04481555
Locations
🇩🇰

Silkeborg Sygehus, Silkeborg, Denmark

🇩🇰

Aarhus University Hospital, Aarhus, Denmark

🇩🇰

Hvidovre Hospital, Copenhagen, Denmark

and more 6 locations

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Phase 1
Conditions
Pulmonary Infection
Sars-CoV2
COVID
Interventions
Drug: Oseltamivir
Drug: Azithromycin
Biological: Umbilical Cord Mesenchymal Stem Cells
First Posted Date
2020-07-07
Last Posted Date
2020-07-07
Lead Sponsor
Indonesia University
Target Recruit Count
40
Registration Number
NCT04457609
Locations
🇮🇩

Sulianti Saroso Center for Infectious Disease, Jakarta, DKI Jakarta, Indonesia

🇮🇩

Universitas Indonesia Hospital, Depok, West Java, Indonesia

🇮🇩

Persahabatan General Hospital, Jakarta, DKI Jakarta, Indonesia

and more 1 locations

A Study of Combination Therapies to Treat COVID-19 Infection

Phase 2
Withdrawn
Conditions
SARS Pneumonia
Corona Virus Infection
Coronavirus Infection
Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere
Coronavirus-19
COVID
SARS-CoV 2
COVID-19
Interventions
First Posted Date
2020-07-07
Last Posted Date
2021-04-08
Lead Sponsor
ProgenaBiome
Registration Number
NCT04459702
Locations
🇺🇸

ProgenaBiome, Ventura, California, United States

Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients

Phase 2
Terminated
Conditions
COVID-19
Interventions
First Posted Date
2020-07-07
Last Posted Date
2023-09-13
Lead Sponsor
University of New Mexico
Target Recruit Count
28
Registration Number
NCT04458948
Locations
🇺🇸

University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States

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