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Last Updated: June 30, 2022

CLINICAL TRIALS PROFILE FOR AZTREONAM


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All Clinical Trials for Aztreonam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00104520 ↗ Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa Completed Gilead Sciences Phase 3 2005-02-01 The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00112359 ↗ International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa Completed Gilead Sciences Phase 3 2005-05-01 The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00128492 ↗ Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) Completed Gilead Sciences Phase 3 2005-08-01 The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
NCT00228410 ↗ Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 2002-11-01 To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections.
NCT00261807 ↗ Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections Completed Cubist Pharmaceuticals LLC N/A 2005-06-01 Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
NCT00261807 ↗ Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections Completed University of Maryland N/A 2005-06-01 Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
NCT00261807 ↗ Daptomycin for the Treatment of Severe Necrotizing Soft-Tissue Infections Completed University of Maryland, Baltimore N/A 2005-06-01 Daptomycin is a new antimicrobial agent which has activity against resistant Gram positive cocci including MRSA. The phase 3 clinical trials for skin and soft tissue infections (SSTI) with Staphylococci and Streptococci have already demonstrated that daptomycin was noninferior to the comparator agent (vancomycin or beta-lactams) (10). Although this clinical trial did not include any patients with clostridial infection, there is in vitro data to support the activity of daptomycin against a variety of clostridial species(11) ( Clostridium perfringens) Therefore, for this trial we will include patients with clostridial infections with this species. Additionally, the patients in the SSTI study were not as ill as the proposed study population. Therefore for treatment of such severe infections, we would like to use a higher dose of daptomycin (6mg/kg/dose). The reasons for using a higher dose of daptomycin in this subgroup are as follows: 1. Patients who are severely ill have an increased volume of distribution; and therefore have a lower serum concentration of daptomycin. These patients might require a higher dose of daptomycin to achieve the desired serum concentration. 2. One of the organisms involved in necrotizing fasciitis is enterococcus (both-fecalis and faecium). E.faecium has higher MICs to daptomycin and would require a higher dose of the drug to achieve adequate free (unbound) serum concentration of the drug. 3. Both necrotizing fasciitis and endocarditis are serious deep seated infections. The clinical trials for endocarditis are using 6mg/kg/dose of daptomycin. Therefore for optimal treatment of necrotizing fasciitis, it is justifiable that we should use the higher dose of daptomycin. Objective: To evaluate the clinical and microbiological efficacy and safety of higher dose daptomycin therapy in the treatment of patients with severe necrotizing skin and soft tissue infections. Type of Study: Open label, single center study.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aztreonam

Condition Name

Condition Name for Aztreonam
Intervention Trials
Cystic Fibrosis 19
Pseudomonas Aeruginosa 4
Bacterial Infections 3
Infection 3
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Condition MeSH

Condition MeSH for Aztreonam
Intervention Trials
Infections 26
Infection 25
Communicable Diseases 23
Fibrosis 19
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Clinical Trial Locations for Aztreonam

Trials by Country

Trials by Country for Aztreonam
Location Trials
United States 438
Australia 23
Spain 22
India 22
Canada 18
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Trials by US State

Trials by US State for Aztreonam
Location Trials
California 25
Florida 23
Texas 22
Illinois 20
Ohio 19
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Clinical Trial Progress for Aztreonam

Clinical Trial Phase

Clinical Trial Phase for Aztreonam
Clinical Trial Phase Trials
Phase 4 6
Phase 3 24
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Aztreonam
Clinical Trial Phase Trials
Completed 43
Terminated 6
Approved for marketing 2
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Clinical Trial Sponsors for Aztreonam

Sponsor Name

Sponsor Name for Aztreonam
Sponsor Trials
Gilead Sciences 20
Pfizer 8
Forest Laboratories 5
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Sponsor Type

Sponsor Type for Aztreonam
Sponsor Trials
Industry 59
Other 34
U.S. Fed 2
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