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
-

Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease

Phase 3
Terminated
Conditions
COVID-19
Interventions
First Posted Date
2020-04-14
Last Posted Date
2022-01-21
Lead Sponsor
LCMC Health
Target Recruit Count
22
Registration Number
NCT04344444
Locations
🇺🇸

University Medical Center New Orleans, New Orleans, Louisiana, United States

Prevention of SARS-CoV-2 in Hospital Workers s Exposed to the Virus

Phase 3
Completed
Conditions
SARS-CoV-2 Infection
Interventions
First Posted Date
2020-04-14
Last Posted Date
2021-08-03
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
122
Registration Number
NCT04344379
Locations
🇫🇷

Hopial Avicenne, Bobigny, France

🇫🇷

Hôpital GHU Paris Saclay, Le Kremlin-Bicêtre, France

🇫🇷

Hôpital Saint Antoine, Paris, France

and more 5 locations

Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection

Phase 3
Terminated
Conditions
Coronavirus Infection
Interventions
First Posted Date
2020-04-10
Last Posted Date
2024-04-25
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
30
Registration Number
NCT04341727
Locations
🇺🇸

Washington University School of Medicine Infectious Disease Clinical Research Unit, Saint Louis, Missouri, United States

🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients

Phase 2
Conditions
Cancer & COVID 19
Interventions
First Posted Date
2020-04-10
Last Posted Date
2020-04-10
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
1000
Registration Number
NCT04341207
Locations
🇫🇷

Gustave Roussy, Villejuif, Val De Marne, France

Study of Immune Modulatory Drugs and Other Treatments in COVID-19 Patients: Sarilumab, Azithromycin, Hydroxychloroquine Trial - CORIMUNO-19 - VIRO

Phase 2
Suspended
Conditions
COVID19
SARS-CoV-2 Infection
Interventions
First Posted Date
2020-04-10
Last Posted Date
2020-05-06
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
27
Registration Number
NCT04341870
Locations
🇫🇷

AP-HP Hôpital Beaujon, Clichy, France

🇫🇷

AP-HP Hôpital Pitié Salpétrière, Paris, France

🇫🇷

AP-HP Hôpital Avicenne, Bobigny, France

and more 2 locations

Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care With COVID-19: Randomised Controlled Trial

Phase 3
Terminated
Conditions
COVID-19
Respiratory Failure
Interventions
First Posted Date
2020-04-09
Last Posted Date
2020-11-06
Lead Sponsor
Frantisek Duska, MD, PhD
Target Recruit Count
3
Registration Number
NCT04339816
Locations
🇨🇿

František Duška, Praha, Česká Republika, Czechia

Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

Phase 3
Completed
Conditions
COVID 19
Interventions
First Posted Date
2020-04-08
Last Posted Date
2022-02-10
Lead Sponsor
Shehnoor Azhar
Target Recruit Count
550
Registration Number
NCT04338698
Locations
🇵🇰

Gujranwala Medical College, Gujrānwāla, Pakistan

🇵🇰

Khyber Teaching Hospital, Peshawar, Pakistan

🇵🇰

Akram Medical Complex, Lahore, Pakistan

and more 8 locations

Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19

Phase 3
Conditions
COVID-19
Interventions
First Posted Date
2020-04-06
Last Posted Date
2020-04-09
Lead Sponsor
Intermountain Health Care, Inc.
Target Recruit Count
1550
Registration Number
NCT04334382
Locations
🇺🇸

Intermountain Medical Center, Murray, Utah, United States

🇺🇸

University of Utah, Salt Lake City, Utah, United States

A Study of Quintuple Therapy to Treat COVID-19 Infection

Phase 2
Completed
Conditions
COVID-19
Corona Virus Infection
Coronavirus-19
Sars-CoV2
Interventions
Drug: Hydroxychloroquine
Drug: Azithromycin
Dietary Supplement: Vitamin C
Dietary Supplement: Vitamin D
Dietary Supplement: Zinc
First Posted Date
2020-04-06
Last Posted Date
2024-02-29
Lead Sponsor
ProgenaBiome
Target Recruit Count
118
Registration Number
NCT04334512
Locations
🇺🇸

ProgenaBiome, Ventura, California, United States

Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

Phase 2
Terminated
Conditions
SARS-CoV-2
Interventions
First Posted Date
2020-04-06
Last Posted Date
2021-05-17
Lead Sponsor
Duke University
Target Recruit Count
11
Registration Number
NCT04335552
Locations
🇺🇸

Durham VA Medical Center, Durham, North Carolina, United States

🇺🇸

Duke University Hospital, Durham, North Carolina, United States

🇺🇸

Duke Regional Hospital, Durham, North Carolina, United States

and more 1 locations
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