A Phase 3 interventional study of Solithromycin and Moxifloxacin in Community-acquired Bacterial Pneumonia, sponsored by Melinta Therapeutics, Inc.. Completed at 270 sites in 26 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by Melinta Therapeutics, Inc. (part of CorMedix Therapeutics) · Phase 3, Interventional, and Treatment
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Community-acquired bacterial pneumonia (CABP) is an acute infection of the pulmonary parenchyma with symptoms such as fever or hypothermia, chills, rigors, chest pain, and/or dyspnea. The widespread emergence of antibiotic resistant pathogens, including the macrolide-resistant Streptococcus pneumoniae, has resulted in a need for new and effective antibiotics that have activity against CABP pathogens. Solithromycin is a fourth generation macrolide antibiotic with excellent activity against resistant S. pneumoniae and other key typical and atypical bacterial respiratory pathogens. A completed Phase 2 study showed comparable efficacy to levofloxacin in adults with CABP.
2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.
This study's enrollment of 863 is above the median of 107 across 1,263 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Melinta Therapeutics, Inc. is the lead sponsor of 32 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
First submitted before Melinta Therapeutics, Inc. became part of CorMedix Therapeutics.
Counted across the registry records on this site, refreshed daily.
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An acute onset of at least 3 of the following signs and symptoms (new or worsening):
At least 1 of the following:
Exclusion Criteria:
Intravenous with the potential step-down to oral moxifloxacin
Drug: Moxifloxacin
Intravenous with potential step-down to oral solithromycin
Drug: Solithromycin
Also known as: CEM-101
Also known as: Avelox
Early clinical response rate in the Intent to Treat (ITT) population.
To determine noninferiority (NI) in early clinical response rate, in at least 2 of the following 4 cardinal symptoms: cough, shortness of breath, chest pain, and sputum production
Time frame: 72 [±12] hours after the first dose of study drug
Early clinical response rate in the microITT population
To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population
Time frame: 72 [±12] hours after the first dose of study drug
Clinical success rates in the ITT and Clinically Evaluable (CE) populations
To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin
Time frame: 5 to 10 days after the last dose of study drug
Showing the first 100 of 270 sites across 26 countries.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Solithromycin