Clinical Trials Resource Center

Gynecological Infections

July 11, 2016

The Medicines Company has announced phase III results of CARBAVANCE (meropenem-vaborbactam) for complicated urinary tract infection (cUTI). TANGO 1 was a multicenter, randomized, double-blind, double-dummy study to evaluate the efficacy, safety and tolerability of CARBAVANCE compared to piperacillin-tazobactam in the treatment of cUTI, including acute pyelonephritis, in adults. The trial enrolled 550 adult patients randomized 1:1 to receive CARBAVANCE (meropenem 2g-vaborbactam 2g) as a three-hour IV infusion every eight hours or piperacillin 4g-tazobactam 500mg as a 30 minute IV infusion every eight hours, each for up to 10 days. After a minimum of five days of IV therapy, patients who met protocol-defined criteria of improvement were transitioned to oral levofloxacin. For the FDA, the primary assessment was performed in the microbiologic modified intent-to-treat (mMITT) patient population, and was defined as overall success of clinical outcome (cure or improvement and microbiologic outcome of eradication (baseline bacterial pathogen reduced to <104 CFU/ml)). Overall success was observed in 188/192 patients (98.4%) in the meropenem-vaborbactam group and in 171/182 patients (94.0%) in the piperacillin-tazobactam group—a difference of 4.5% (95% CI: 0.7 % to 9.1%). For the EMA, the primary assessment was defined as microbiologic outcome of eradication (baseline bacterial pathogen reduced to <103 CFU/ml) at the test-of-cure (TOC) visit in the mMITT and microbiologic evaluable (ME) patient populations. For the mMITT patient population, the microbiological eradication was 128/192 patients (66.7%) in the meropenem-vaborbactam group and 105/182 patients (57.7%) in the piperacillin-tazobactam group—a difference of 9.0% (95% CI: -0.9% to 18.7%). For the ME patient population, the microbiological eradication was 118/178 patients (66.3%) in the meropenem-vaborbactam group and 102/169 patients (60.4%) in the piperacillin-tazobactam group—a difference of 5.9% (95% CI: -4.2% to 16%). The company believes that TANGO 1 provides the pivotal clinical data necessary for the submission of an NDA with the FDA and a marketing authorization application (MAA) with the EMA. 

August 26, 2002

In an open label study of topical nitroglycerin (NTG) in subjects with vulvodynia, results showed significant decreases in pain intensity and frequency of overall pain. Improvement in pain was reported by 31 of the 34 female subjects. Cellegy Pharmaceuticals, who sponsored the study, plans to develop a topical NTG product for the vulvodynia indication.

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