scholarly journals Comparative study of the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections in hospitalized adults: results of a randomized, double-blind, Phase II trial

2013 ◽  
Vol 68 (5) ◽  
pp. 1183-1192 ◽  
Author(s):  
Christopher Lucasti ◽  
Irinel Popescu ◽  
Mayakonda K. Ramesh ◽  
Joy Lipka ◽  
Carole Sable
Keyword(s):  
Comparative Study ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Abdominal Infections

scholarly journals Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: design of a double-blind, randomised, placebo-controlled phase II trial

2018 ◽  
Vol 5 (1) ◽  
pp. e000289 ◽  
Author(s):  
Toby M Maher ◽  
Tamera J Corte ◽  
Aryeh Fischer ◽  
Michael Kreuter ◽  
David J Lederer ◽  
...  
Keyword(s):  
Interstitial Lung Disease ◽  
Lung Disease ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Good Clinical Practice ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Patient Reported ◽  
Biomarker Analysis ◽  
Study Participants

IntroductionDespite extensive multidisciplinary team (MDT) assessment, some patients have interstitial lung disease (ILD) that is considered unclassifiable (uILD), for which there are currently no approved treatments. This study will assess the efficacy and safety of the antifibrotic pirfenidone in treating uILD.Methods and analysisThis double-blind, randomised, placebo-controlled phase II trial is enrolling adults with fibrosing ILD, including uILD that fulfils proposed research criteria for interstitial pneumonia with autoimmune features (IPAF), that cannot be classified with moderate or high confidence to any category of ILD following MDT discussion. Study participants must have >10% fibrosis on high-resolution CT scan within the previous 12 months, forced vital capacity (FVC) ≥45% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomised to receive 801 mg pirfenidone or placebo three times daily for 24 weeks. The efficacy of pirfenidone vs placebo will be assessed by daily measurement of FVC using a handheld spirometer over the treatment period. Other functional parameters, patient-reported outcomes, samples for biomarker analysis and safety endpoints will be collected. Additionally, the study will assess the efficacy and safety of pirfenidone with and without concomitant mycophenolate mofetil treatment and in study participants with or without IPAF.Ethics and disseminationThis trial is being conducted in accordance with the International Conference on Harmonisation E6 guideline for Good Clinical Practice, Declaration of Helsinki and local laws for countries in which the research is conducted.Trial registration numberNCT03099187.

scholarly journals Multicenter, Double-Blind, Randomized, Phase II Trial To Assess the Safety and Efficacy of Ceftolozane-Tazobactam plus Metronidazole Compared with Meropenem in Adult Patients with Complicated Intra-Abdominal Infections

2014 ◽  
Vol 58 (9) ◽  
pp. 5350-5357 ◽  
Author(s):  
Christopher Lucasti ◽  
Ellie Hershberger ◽  
Benjamin Miller ◽  
Sara Yankelev ◽  
Judith Steenbergen ◽  
...  
Keyword(s):  
Phase Ii ◽  
Clinical Cure ◽  
Phase Ii Trial ◽  
Success Rates ◽  
Double Blind ◽  
Content Type ◽  
Randomized Phase Ii ◽  
Intent To Treat ◽  
Abdominal Infections ◽  
Event Rates

ABSTRACTCeftolozane-tazobactam (TOL-TAZ) is a novel antibacterial with activity againstPseudomonas aeruginosaand other common Gram-negative pathogens, including extended-spectrum β-lactamase (ESBL)-producingEnterobacteriaceae, that are associated with complicated intra-abdominal infections (cIAIs). This prospective, double-blind, randomized, multicenter, phase II trial assessed patient clinical and microbiological responses to and the safety of TOL-TAZ plus metronidazole compared with those of meropenem. Hospitalized adults with cIAIs that required surgical intervention were randomized (2:1) to receive intravenous (i.v.) TOL-TAZ (1.5 g [containing 1,000 mg TOL and 500 mg TAZ] every 8 h [q8h]) with or without i.v. metronidazole (500 mg q8h) or i.v. meropenem (1 g q8h) for 4 to 7 days. The primary endpoint was the clinical response at the test-of-cure visit in the microbiologically modified intent-to-treat (mMITT) and microbiologically evaluable (ME) populations. Secondary measures included the patients' microbiological response and safety. In total, 82 patients received TOL-TAZ (90.2% with metronidazole), and 39 received meropenem. For the mMITT population, clinical cure was seen in 83.6% of the patients (51/61; 95% confidence interval [CI], 71.9 to 91.8) who received TOL-TAZ and 96.0% of the patients (24/25; 95% CI, 79.6 to 99.9) who received meropenem (difference, −12.4%; 95% CI, −34.9% to 11.1%); in the ME population, clinical cure was seen in 88.7% and 95.8% of the patients (difference, −7.1%; 95% CI, −30.7% to 16.9%) who received TOL-TAZ and meropenem, respectively. TOL-TAZ demonstrated microbiological success againstEscherichia coli(89.5%),Klebsiella pneumoniae(100%), andP. aeruginosa(100%). The adverse event rates were similar in the groups (50.0% with TOL-TAZ and 48.8% with meropenem). TOL-TAZ in combination with metronidazole was well tolerated and resulted in clinical and microbiological success rates supportive of further clinical development in patients with cIAIs. (This study has been registered at ClinicalTrials.gov under registration no. NCT01147640.)

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