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Last Updated: May 26, 2022

CLINICAL TRIALS PROFILE FOR ZITHROMAX


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505(b)(2) Clinical Trials for Zithromax

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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Zithromax

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00035347 ↗ Intravenous Azithromycin Plus Intravenous Ceftriaxone Followed by Oral Azithromycin With Intravenous Levofloxacin Followed by Oral Levofloxacin for the Treatment of Moderate to Severely Ill Hospitalized Patients With Community Acquired Pneumonia Completed Pfizer Phase 4 2001-01-01 A trial in which patients over 18 years of age who are hospitalized with community acquired pneumonia and are otherwise eligible for entry into the study are randomly selected to receive one of two treatment regimens. After written informed consent is obtained, patients will receive one of the following two treatment regimens: 1) intravenous administration of azithromycin and ceftriaxone followed by azithromycin tablets, or 2) intravenous administration of levofloxacin followed by levofloxacin tablets. At least four study visits are normally conducted up to approximately one month after starting therapy. The objective of this study is to compare the safety and efficacy of the two treatment regimens.
NCT00137007 ↗ Zithromax EV in Community-Acquired Pneumonia (CAP) Completed Pfizer Phase 4 2003-11-01 The intravenous (IV) regimen containing azithromycin (Zithromax) plus ampicillin-sulbactam is consistent with current guidelines for the treatment of CAP. In fact the International guidelines for the treatment of CAP in hospitalised patients suggests the use of a combination between a b-lactam and a macrolide. This trial will allow investigators to evaluate the efficacy of azithromycin plus ampicillin-sulbactam in the treatment of hospitalized subjects with community acquired pneumonia. In addition, this trial will allow investigators to evaluate the safety and toleration of combination therapy.
NCT00237445 ↗ Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days Terminated Sanofi Phase 4 2005-11-01 A multinational, multicenter, randomized, double-blind, study in areas of high pneumococcal resistance comparing the clinical efficacy and health outcomes of outpatients with mild to moderate Community-Acquired Pneumonia (CAP) treated with either telithromycin once daily for 7 days, or azithromycin once daily for 5 days
NCT00266851 ↗ AZMATICS: AZithroMycin/Asthma Trial In Community Settings Completed American Academy of Family Physicians Phase 3 2006-01-01 The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗ AZMATICS: AZithroMycin/Asthma Trial In Community Settings Completed Dean Foundation Phase 3 2006-01-01 The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
NCT00266851 ↗ AZMATICS: AZithroMycin/Asthma Trial In Community Settings Completed Pfizer Phase 3 2006-01-01 The purpose of this study is to assess the effectiveness of the azalide macrolide azithromycin in adults with persistent asthma. Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a statistically significant and clinically meaningful improvement in overall asthma symptoms and other patient-oriented asthma outcomes one year after initiation of treatment of adult primary care patients with asthma? Experimental Design: The investigators propose a one-year randomized, placebo-controlled, blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel observational cohort who will participate 'open label' in 100 adult asthma patients recruited from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN) and others). This "practical clinical trial" will (1) enroll a representative sample of asthma patients encountered in the practices of primary care physicians, (2) employ standard clinical trial methodology to ensure internally valid results and (3) measure outcomes important to patients, so that the results will be valid and applicable to the kinds of asthma patients encountered by family physicians and other primary care providers. Active study sites - - Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison, - Mauston, Rice Lake, Tomah, Wausau - Colorado: Monument - Illinois: Peoria - Nevada: Reno - North Carolina: Granite Falls - North Dakota: Minot - Ohio: Cleveland, Berea - Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford - Rhode Island: East Providence
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zithromax

Condition Name

Condition Name for Zithromax
Intervention Trials
Healthy 7
Trachoma 7
Malaria 6
COVID-19 5
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Condition MeSH

Condition MeSH for Zithromax
Intervention Trials
Infections 11
Infection 11
Communicable Diseases 9
Malaria 8
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Clinical Trial Locations for Zithromax

Trials by Country

Trials by Country for Zithromax
Location Trials
United States 201
Canada 15
France 14
Australia 11
United Kingdom 8
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Trials by US State

Trials by US State for Zithromax
Location Trials
California 20
Maryland 12
Texas 9
Illinois 8
Pennsylvania 8
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Clinical Trial Progress for Zithromax

Clinical Trial Phase

Clinical Trial Phase for Zithromax
Clinical Trial Phase Trials
Phase 4 33
Phase 3 16
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Zithromax
Clinical Trial Phase Trials
Completed 62
Recruiting 12
Withdrawn 7
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Clinical Trial Sponsors for Zithromax

Sponsor Name

Sponsor Name for Zithromax
Sponsor Trials
University of California, San Francisco 16
Pfizer 15
Bill and Melinda Gates Foundation 9
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Sponsor Type

Sponsor Type for Zithromax
Sponsor Trials
Other 204
Industry 35
NIH 11
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