Community-acquired Bacterial Pneumonia
Conditions
Keywords
Pneumonia, CABP, CAP, Macrolide
Brief summary
This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.
Detailed description
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.
Interventions
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients ≥ 18 years of age * An acute onset of at least 3 of the following signs and symptoms (new or worsening): 1. Cough 2. Production of purulent sputum 3. Shortness of breath (dyspnea) 4. Chest pain due to pneumonia * At least 1 of the following: 1. Fever 2. Hypothermia 3. Presence of pulmonary rales and/or evidence of pulmonary consolidation * PORT Risk Class II, III, or IV * Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study * Not received any systemic antibiotics during the prior 7 days
Exclusion criteria
* Ventilator-associated pneumonia * Known anatomical or pathological bronchial obstruction or a history of bronchiectasis or documented severe chronic obstructive pulmonary disease * Hospitalization within 90 days or residence in a long-term care facility within 30 days prior to the onset of symptoms * Presence of known: 1. Viral or fungal pneumonia 2. Pneumocystis jiroveci pneumonia 3. Aspiration pneumonia 4. Other non-infectious causes of pulmonary infiltrates (e.g. pulmonary embolism, hypersensitivity pneumonia, congestive heart failure) 5. Primary or metastatic lung cancer 6. Cystic fibrosis 7. Active or suspected tuberculosis * Known HIV or myasthesia gravis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early clinical response rate in the Intent to Treat (ITT) population | 72 [±12] hours after the first dose of study drug | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early clinical response rate in the microITT population | 72 [±12] hours after the first dose of study drug | To determine NI in early clinical response rate of oral solithromycin compared to oral moxifloxacin in the mITT population |
| Clinical success rates in the ITT and Clincally Evaluable (CE) populations | 5 to 10 days after the last dose of study drug | To determine the overall clinical success rates of oral solithromycin compared to moxifloxacin |
Countries
Argentina, Bulgaria, Canada, Czechia, Dominican Republic, Ecuador, Estonia, Germany, Hungary, Latvia, Poland, Puerto Rico, Romania, Russia, South Africa, Spain, United States
Outcome results
None listed