A Phase 2 interventional study of Ceftaroline fosamil and NXL104 (q8h) and Ceftaroline fosamil and NXL104 (q12h) in Urinary Tract Infections, sponsored by Forest Laboratories. Completed at 50 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-03.
Sponsored by Forest Laboratories · Phase 2, Interventional, and Treatment
This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 217 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must meet the following inclusion criteria:
Exclusion Criteria:
Subjects must NOT meet any of the following exclusion criteria:
Drug: Ceftaroline fosamil and NXL104 (q8h) · Drug: Placebo
Drug: Ceftaroline fosamil and NXL104 (q12h) · Drug: Placebo
Drug: Doripenem · Drug: Placebo
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
Also known as: Ceftaroline fosamil and Avibactam(NXL104) (q8h)
600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
Also known as: Ceftaroline fosamil and Avibactam(NXL104) (q12h)
500 mg doripenem IV q8h;
On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
Also known as: placebo (saline)
Microbiological response of Microbiologically Evaluable (ME) at Test of Cure (TOC)
The number and percentage of subjects in each treatment group recorded as having a favorable microbiological response in the ME Population at Test-of-Cure (TOC)
Time frame: 5 to 11 days after last dose of study drug
Evaluate safety
Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI. Summaries of AEs, SAEs, deaths, laboratory evaluations (hematology and coagulation studies, comprehensive metabolic panel, and urinalysis), vital signs, ECGs, and physical examinations will be provided for each treatment group.
Time frame: from administration of first dose of study drug to the Late -Follow -Up (LFU) visit (28 to 42 days after administration of the last dose of study drug)
Clinical response in CE at Test of Cure
The number and percentage of subjects in each treatment group classified as clinical cure Clinically Evaluable (CE) Population at TOC
Time frame: 5 to 11 days after last dose of study drug
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Forest Laboratories