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
-

Effects of Mass Drug Administration of Azithromycin on Mortality and Other Outcomes Among 1-11 Month Old Infants in Mali

Phase 3
Active, not recruiting
Conditions
Mortality
Interventions
Drug: Placebo
Drug: Azithromycin
First Posted Date
2020-06-11
Last Posted Date
2024-12-12
Lead Sponsor
Tampere University
Target Recruit Count
100000
Registration Number
NCT04424511
Locations
🇲🇱

Center for Vaccine Development CVD-Mali, Bamako, Mali

Ivermectin-Azithromycin-Cholecalciferol (IvAzCol) Combination Therapy for COVID-19

Not Applicable
Completed
Conditions
COVID
Interventions
First Posted Date
2020-05-22
Last Posted Date
2022-03-10
Lead Sponsor
Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
Target Recruit Count
30
Registration Number
NCT04399746
Locations
🇲🇽

Outpatient treatment, Mexico City, Mexico

International ALLIANCE Study of Therapies to Prevent Progression of COVID-19

Phase 2
Conditions
COVID19
Interventions
Dietary Supplement: Vitamin C
Drug: Hydroxychloroquine
Drug: Azithromycin
Dietary Supplement: Zinc Citrate
Dietary Supplement: Vitamin D3
Dietary Supplement: Vitamin B12
First Posted Date
2020-05-20
Last Posted Date
2020-09-11
Lead Sponsor
National Institute of Integrative Medicine, Australia
Target Recruit Count
200
Registration Number
NCT04395768
Locations
🇦🇺

National Institute of Integrative Medicine, Melbourne, Victoria, Australia

Ultra Low Doses of Therapy With Radiation Applicated to COVID-19

Not Applicable
Suspended
Conditions
Pneumonia, Viral
Cytokine Storm
Interventions
Radiation: Ultra-Low-dose radiotherapy
Device: ventilatory support with oxygen therapy
Drug: Lopinavir/ritonavir
Drug: Hydroxychloroquine
Drug: Azithromycin
Drug: Piperacillin/tazobactam
Drug: Low molecular weight heparin
Drug: Corticosteroid injection
Drug: Tocilizumab
First Posted Date
2020-05-19
Last Posted Date
2022-03-29
Lead Sponsor
Fundacion GenesisCare
Target Recruit Count
15
Registration Number
NCT04394182
Locations
🇪🇸

Hospital La Milagrosa, GenesisCare, Madrid, Spain

🇪🇸

Hospital Vithas Valencia Consuelo, Valencia, Spain

Randomised Evaluation of COVID-19 Therapy

Phase 3
Recruiting
Conditions
Severe Acute Respiratory Syndrome
Interventions
Drug: Lopinavir-Ritonavir
Biological: Convalescent plasma
Biological: Immunoglobulin
Drug: Corticosteroid
Drug: Synthetic neutralising antibodies
Drug: Empagliflozin
Drug: Anakinra
Drug: High Dose Corticosteroid
Drug: Sotrovimab
Drug: Paxlovid
Drug: Baloxavir Marboxil
Drug: Hydroxychloroquine
Drug: Azithromycin
Drug: Tocilizumab
Drug: Aspirin
Drug: Dimethyl fumarate
Drug: Colchicine
Drug: Baricitinib
Drug: Oseltamivir
Drug: Molnupiravir
First Posted Date
2020-05-11
Last Posted Date
2024-01-05
Lead Sponsor
University of Oxford
Target Recruit Count
70000
Registration Number
NCT04381936
Locations
🇻🇳

Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam

🇬🇭

Kumasi Center for Collaborative Research in Tropical Medicine KNUST, Kumasi, Ghana

🇮🇳

Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, New Delhi, India

and more 4 locations

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Not Applicable
Conditions
Pneumonia, Viral
Interventions
Radiation: Low-dose radiotherapy
Drug: Hydroxychloroquine Sulfate
Drug: Ritonavir/lopinavir
Drug: Tocilizumab Injection [Actemra]
Drug: Azithromycin
Drug: Corticosteroid
Drug: Low molecular weight heparin
Device: Oxygen supply
First Posted Date
2020-05-08
Last Posted Date
2021-07-30
Lead Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Target Recruit Count
106
Registration Number
NCT04380818
Locations
🇪🇸

Hospital Sant Joan de Reus, Reus, Tarragona, Spain

🇪🇸

Hospital Del Mar, Barcelona, Spain

🇪🇸

Hospital Universitario Madrid Sanchinarro, Madrid, Spain

Hydroxychloroquine and Zinc With Either Azithromycin or Doxycycline for Treatment of COVID-19 in Outpatient Setting

First Posted Date
2020-05-01
Last Posted Date
2020-12-09
Lead Sponsor
St. Francis Hospital, New York
Target Recruit Count
18
Registration Number
NCT04370782
Locations
🇺🇸

St Francis Hospital, Roslyn, New York, United States

Proactive Care of Ambulatory COVID19 Patients

Phase 3
Suspended
Conditions
Azithromycin
Ambulatory
Covid19
Interventions
Other: consultation
Drug: Azithromycin
First Posted Date
2020-05-01
Last Posted Date
2023-03-21
Lead Sponsor
Centre Hospitalier Universitaire, Amiens
Target Recruit Count
11
Registration Number
NCT04371107
Locations
🇫🇷

CHU Amiens, Amiens, France

Bacteriotherapy in the Treatment of COVID-19

Conditions
Diarrhea
COVID
Pneumonia
Interventions
Dietary Supplement: SivoMixx (200 billion)
Drug: hydroxychloroquine
Drug: Azithromycin
First Posted Date
2020-04-29
Last Posted Date
2020-05-04
Lead Sponsor
University of Roma La Sapienza
Target Recruit Count
70
Registration Number
NCT04368351
Locations
🇮🇹

Department of Public Heath and Infectious Diseases. University of Rome "Sapienza" (Italy), Rome, Italy

OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome

First Posted Date
2020-04-28
Last Posted Date
2021-04-27
Lead Sponsor
Fondation Hôpital Saint-Joseph
Registration Number
NCT04365582
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