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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR AZTREONAM

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Clinical Trials for Aztreonam

Trial ID Title Status Sponsor Phase Summary
NCT00104520 Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa Completed Gilead Sciences Phase 3 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 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 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 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 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 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.
NCT00303589 A Study of Beta-Lactam in Hospitalized Patients With Skin and Skin Structure Infections Completed Hoffmann-La Roche Phase 2 This 3 arm study will compare the efficacy and safety of beta-lactam with that of 'standard care' in patients with complicated skin and skin structure infections requiring hospitalization. Patients will be randomized to receive 1)beta-lactam 750mg iv q8h 2)beta-lactam 1500mg iv q8h or 3)'standard care' [PRP (nafcillin or flucloxacillin) or vancomycin, plus aztreonam or ciprofloxacin]. The anticipated time on study treatment is <3 months and the target sample size is 100-500 individuals.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Aztreonam

Condition Name

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

Condition MeSH for Aztreonam
Intervention Trials
Infection 23
Communicable Diseases 21
Fibrosis 19
Cystic Fibrosis 19
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Clinical Trial Locations for Aztreonam

Trials by Country

Trials by Country for Aztreonam
Location Trials
United States 399
Australia 23
Canada 18
Spain 14
Brazil 11
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Trials by US State

Trials by US State for Aztreonam
Location Trials
Texas 20
Florida 20
California 19
Ohio 16
Illinois 16
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Clinical Trial Progress for Aztreonam

Clinical Trial Phase

Clinical Trial Phase for Aztreonam
Clinical Trial Phase Trials
Phase 4 5
Phase 3 23
Phase 2 13
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Clinical Trial Status

Clinical Trial Status for Aztreonam
Clinical Trial Phase Trials
Completed 29
Not yet recruiting 6
Recruiting 6
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Clinical Trial Sponsors for Aztreonam

Sponsor Name

Sponsor Name for Aztreonam
Sponsor Trials
Gilead Sciences 19
Forest Laboratories 4
Cubist Pharmaceuticals LLC 4
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Sponsor Type

Sponsor Type for Aztreonam
Sponsor Trials
Industry 47
Other 26
U.S. Fed 1
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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Accenture
Julphar
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Merck
Chubb
Argus Health

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