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Last Updated: June 14, 2025

CLINICAL TRIALS PROFILE FOR AZITHROMYCIN


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505(b)(2) Clinical Trials for Azithromycin

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT00694694 ↗ Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed National Institute for Medical Research, Tanzania Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
New Combination NCT00694694 ↗ Azithromycin + Artesunate v Artemether-lumefantrine in Uncomplicated Malaria. Completed London School of Hygiene and Tropical Medicine Phase 3 2008-06-01 This trial sets out to determine whether the combination of azithromycin and artesunate (AZ+AS) is as good as the current standard treatment for uncomplicated malaria in Tanzania, artemether-lumefantrine (AL). There are two reasons this is important 1. there are only a limited range of drug combinations which work against malaria in this area of Tanzania 2. azithromycin has antimalarial properties, but is also a broad-spectrum antibiotic, so if the combination is an effective antimalarial it might have a place where there are no diagnostic facilities as syndromic treatment for fever. Artesunate and azithromycin have both been used alone or in combination with other drugs in children in Tanzania for many years, and are considered safe. There is trial evidence for the effectiveness of this combination in adults in Asia, as well as in-vitro (laboratory) evidence that it works against the malaria parasite. The trial randomizes children with non-severe malaria to the new combination AZ+AS or the standard care arm AL. The primary outcome is the parasitological failure rate by day 28- meaning do malaria parasites get cleared, and stay cleared for at least 28 days. Secondary outcomes include safety.
OTC NCT01560962 ↗ Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis Terminated Southern California Institute for Research and Education N/A 2012-01-01 Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments. Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups. In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention. In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash. In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days. In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin. Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.
New Combination NCT03431168 ↗ A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV Active, not recruiting University of Alabama at Birmingham Phase 2 2018-03-07 More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.
OTC NCT04590274 ↗ 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) Not yet recruiting International Brain Research Foundation Phase 1 2020-11-01 Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Azithromycin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000617 ↗ Azithromycin and Coronary Events Study (ACES) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1998-09-01 To determine whether treatment with azithromycin decreases the rate of coronary heart disease events among patients with stable documented coronary artery disease.
NCT00000641 ↗ A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals. Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 To compare the effectiveness and toxicity of two combination drug treatment programs for the treatment of disseminated Mycobacterium avium infection in HIV seropositive patients. [Per 03/06/92 amendment: to evaluate the efficacy of azithromycin when given in conjunction with either ethambutol or clofazimine as maintenance therapy.] Disseminated M. avium infection is the most common systemic bacterial infection complicating AIDS in the United States. The prognosis of patients with disseminated M. avium is extremely poor, particularly when it follows other opportunistic infections or is associated with anemia. Test tube studies and clinical data indicate that the best treatment program may include clofazimine, ethambutol, a rifamycin derivative, and ciprofloxacin. Test tube and animal studies indicate that amikacin is a bactericidal (bacteria destroying) drug that works better when used with ciprofloxacin. Its role in treatment programs is a key issue because of toxicity and because it must be administered parenterally (by injection or intravenously).
NCT00000811 ↗ A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Completed Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Phase 2 1969-12-31 This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.
NCT00000811 ↗ A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Completed Glaxo Wellcome Phase 2 1969-12-31 This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.
NCT00000811 ↗ A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Completed Pfizer Phase 2 1969-12-31 This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.
NCT00000811 ↗ A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 1969-12-31 This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs. SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.
NCT00000883 ↗ Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1997-10-01 The purpose of this study is to see if there are any changes in sugar and fat levels in the blood when patients take anti-HIV therapy for many years. Another goal is to test memory and mental concentrations to determine if anti-HIV drugs protect the brain from damage caused by HIV. (The purpose of this study has been changed from the original version.) HIV-infected patients with low CD4 cell counts are at risk for getting opportunistic (AIDS-related) infections. CD4 cells are cells of the immune system that help fight infection. Anti-HIV therapy may increase CD4 counts, which may lead to a decrease in AIDS-related infections. Problems that anti-HIV therapy is associated with include metabolic problems, neurologic problems, abnormal opportunistic infections, and cancer. Patients in ACTG 362 have been exposed to anti-HIV therapy longer than any other large group in the ACTG. These patients appear to benefit from their therapy, but also suffer problems from it. Observation of these patients should provide more information about long-term anti-HIV treatment and may detect unexpected problems. (This study as been changed. More information about the reasons for conducting this study has been added.)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Azithromycin

Condition Name

Condition Name for Azithromycin
Intervention Trials
Covid-19 37
HIV Infections 22
Covid19 21
Malaria 16
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Condition MeSH

Condition MeSH for Azithromycin
Intervention Trials
COVID-19 91
Infections 72
Infection 70
Communicable Diseases 58
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Clinical Trial Locations for Azithromycin

Trials by Country

Trials by Country for Azithromycin
Location Trials
United States 797
Japan 71
Brazil 69
Canada 49
India 43
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Trials by US State

Trials by US State for Azithromycin
Location Trials
California 64
Texas 41
Pennsylvania 37
North Carolina 37
New York 37
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Clinical Trial Progress for Azithromycin

Clinical Trial Phase

Clinical Trial Phase for Azithromycin
Clinical Trial Phase Trials
Phase 4 135
Phase 3 142
Phase 2/Phase 3 30
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Clinical Trial Status

Clinical Trial Status for Azithromycin
Clinical Trial Phase Trials
Completed 292
Recruiting 82
Not yet recruiting 54
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Clinical Trial Sponsors for Azithromycin

Sponsor Name

Sponsor Name for Azithromycin
Sponsor Trials
Pfizer 69
National Institute of Allergy and Infectious Diseases (NIAID) 31
University of California, San Francisco 29
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Sponsor Type

Sponsor Type for Azithromycin
Sponsor Trials
Other 978
Industry 174
NIH 55
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Azithromycin: Clinical Trials, Market Analysis, and Projections

Introduction to Azithromycin

Azithromycin is a macrolide antibiotic widely used for treating various bacterial infections, including respiratory infections, sexually transmitted infections (STIs), and other bacterial diseases. Its broad-spectrum activity, ease of administration, and favorable safety profile make it a preferred choice in many clinical settings.

Clinical Trials and Outcomes

MORDOR and AVENIR Trials

Significant clinical trials have highlighted the efficacy of azithromycin in reducing childhood mortality. The "Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance" (MORDOR) trial, conducted in Niger, Tanzania, and Malawi, demonstrated that biannual azithromycin distribution reduced overall mortality in children aged 1-59 months, particularly in younger children[1].

The "Azithromycine pour la Vie des Enfants au Niger: Implementation et Recherche" (AVENIR) trial further validated these findings and compared the mortality reduction when treating only 1-11 month-olds versus 1-59 month-olds. The trial showed better outcomes for the younger children when the older children were also treated, highlighting a herd effect[1].

Trachoma Control and Antibiotic Resistance

Azithromycin is also a key component in trachoma control programs. Mass distribution of azithromycin has been shown to reduce trachoma infection, although it also selects for macrolide resistance in various bacteria. However, the resistance decreases when the treatment programs are stopped, indicating that targeted and periodic use can mitigate this issue[1].

Pregnancy and STI Prevention

A randomized, double-masked, placebo-controlled trial in Cameroon tested the effectiveness of azithromycin as an adjunct to trimethoprim-sulfamethoxazole (TMP-SMX) in preventing malaria and STIs in pregnant women with HIV. While the trial did not show a significant reduction in malaria or STIs, it highlighted azithromycin's safety profile and potential benefits in reducing adverse birth outcomes[4].

Market Analysis

Current Market Size and Growth

The global azithromycin market was valued at USD 7.77 billion in 2024 and is projected to reach USD 11.92 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 5.50% during the forecast period of 2025 to 2032[2].

Market Segmentation

The azithromycin market is segmented by source (in-house and contract manufacturing organizations), type (oral, injection, and ophthalmic), application (bacterial infections, Mycobacterium Avium Complex (MAC) infection, and others), demographic (children and adults), end-users (clinics, hospitals, and others), and distribution channels (hospital pharmacy, retail pharmacy, and online pharmacy)[2].

Drivers of Market Growth

Increasing Prevalence of Respiratory Infections

The rising global prevalence of respiratory infections such as pneumonia, bronchitis, and sinusitis significantly drives the demand for azithromycin. The COVID-19 pandemic has further increased its use in treating bacterial respiratory infections[2].

Growing Incidence of Sexually Transmitted Infections (STIs)

Azithromycin's effectiveness in treating STIs like chlamydia and gonorrhea makes it a crucial antibiotic in this area. The World Health Organization (WHO) reports over 1 million STIs acquired daily worldwide, contributing to the growing need for azithromycin[2].

Technological Advancements

Innovations in drug delivery systems, such as continuous flow reactors and nanoformulations, are enhancing azithromycin's production efficiency and bioavailability. Controlled-release formulations are also improving patient compliance by reducing the frequency of dosing[2].

Market Trends

Growing Demand for Azithromycin in Respiratory Infections

The increasing demand for azithromycin in treating respiratory infections, especially during the COVID-19 pandemic, has been a significant trend. Azithromycin's use in combination with other drugs for severe cases of pneumonia and bronchitis has gained popularity[2].

Rising Awareness of Antibiotic Options

There is a growing awareness of the importance of antibiotic stewardship and the need for effective antibiotics like azithromycin. This awareness, coupled with the emergence of antibiotic-resistant bacteria, is driving the adoption of advanced azithromycin formulations[2].

Challenges and Opportunities

Challenges

  • Antibiotic Resistance: The proliferation of antibiotic-resistant bacteria is a significant challenge. Ongoing surveillance of resistance patterns and prudent antibiotic stewardship are essential to address this issue[5].
  • Safety Concerns: Over-prescription and safety concerns are other challenges that need to be managed through careful prescribing practices and regulatory oversight[5].

Opportunities

  • Innovations in Drug Delivery: Research into novel drug delivery systems such as nanoparticles or liposomes could revolutionize azithromycin application by improving bioavailability and targeted delivery[5].
  • Combination Therapies: Exploring combination therapies that enhance efficacy while mitigating resistance development presents substantial potential for market expansion[5].

Future Projections

Market Size and Growth

By 2030, the azithromycin market is expected to reach USD 10.33 billion, growing at a CAGR of 5.68% from 2025 to 2030. This growth is driven by the rising prevalence of infections, global increases in healthcare expenditures, and frequent approvals for new indications and formulations[5].

Geographical Expansion

The market is expected to expand across various regions, with significant growth anticipated in developing nations due to the increasing burden of lower respiratory infections and other bacterial diseases[2].

Key Takeaways

  • Azithromycin has shown significant efficacy in reducing childhood mortality and treating various bacterial infections.
  • The global azithromycin market is projected to grow substantially, driven by the increasing prevalence of respiratory infections and STIs.
  • Technological advancements in drug delivery systems and the development of new formulations are key drivers of market growth.
  • Managing antibiotic resistance and safety concerns are critical challenges that need to be addressed.

FAQs

What are the primary applications of azithromycin?

Azithromycin is primarily used to treat bacterial infections such as respiratory infections (pneumonia, bronchitis), STIs (chlamydia, gonorrhea), and other bacterial diseases.

How does azithromycin impact childhood mortality?

Clinical trials like the MORDOR and AVENIR trials have shown that biannual azithromycin distribution can reduce overall mortality in children aged 1-59 months, particularly in younger children.

What are the key drivers of the azithromycin market growth?

The market growth is driven by the increasing prevalence of respiratory infections, the growing incidence of STIs, technological advancements in drug delivery systems, and the emergence of antibiotic-resistant bacteria.

What are the challenges facing the azithromycin market?

The main challenges include the proliferation of antibiotic-resistant bacteria, safety concerns regarding over-prescription, and stringent regulatory environments.

How is azithromycin used in pregnancy?

Azithromycin is used as an adjunct to other prophylactic regimens to prevent malaria and STIs in pregnant women with HIV, although its effectiveness in these contexts is still under study.

Sources

  1. Grand Rounds September 27, 2024: Azithromycin for Childhood Mortality - Randomizing Entire Countries - Rethinking Clinical Trials.
  2. Global Azithromycin Market Size, Share, Trends & Forecast By 2032 - Data Bridge Market Research.
  3. Azithromycin Market Trend, Forecast, Drivers, Restraints, Company Profiles and Key Players Analysis by 2028 - BioSpace.
  4. A Randomized, Double-Masked, Placebo-Controlled, Phase IIB Clinical Trial - Open Forum Infectious Diseases.
  5. Azithromycin Market Size & Share 2025-2030 - 360iResearch.
Last updated: 2025-01-01

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