You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

CLINICAL TRIALS PROFILE FOR AZTREONAM


✉ Email this page to a colleague

« Back to Dashboard


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.
>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
Bronchiectasis 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for aztreonam
Intervention Trials
Infections 29
Communicable Diseases 26
Infection 25
Fibrosis 19
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for aztreonam

Trials by Country

Trials by Country for aztreonam
Location Trials
United States 440
Australia 23
Spain 22
India 22
China 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for aztreonam
Location Trials
California 25
Florida 23
Texas 22
Illinois 20
Ohio 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for aztreonam

Clinical Trial Phase

Clinical Trial Phase for aztreonam
Clinical Trial Phase Trials
Phase 4 6
Phase 3 26
Phase 2/Phase 3 2
[disabled in preview] 25
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for aztreonam
Clinical Trial Phase Trials
Completed 43
Terminated 6
Recruiting 5
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for aztreonam

Sponsor Name

Sponsor Name for aztreonam
Sponsor Trials
Gilead Sciences 20
Pfizer 9
Cubist Pharmaceuticals LLC 5
[disabled in preview] 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for aztreonam
Sponsor Trials
Industry 62
Other 35
U.S. Fed 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.