Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia (SOLITAIRE-IV)

Melinta Therapeutics

Status and phase: Completed; Phase 3

Conditions: Community-acquired Bacterial Pneumonia

Treatments: Drug: Moxifloxacin; Drug: Solithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968733

CE01-301

Details and patient eligibility

About

This study will evaluate the safety and efficacy of an experimental antibiotic, solithromycin, in the treatment of adult patients with community-acquired pneumonia.

Full 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.

Enrollment: 863 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Fungal pneumonia
• Pneumocystis jiroveci pneumonia
• Aspiration pneumonia
• Other non-infectious causes of pulmonary infiltrates
• Primary or metastatic lung cancer
• Cystic fibrosis
• Active or suspected tuberculosis
• HIV or myasthenia gravis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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863 participants in 2 patient groups

Moxifloxacin

Active Comparator group

Description:

Intravenous with the potential step-down to oral moxifloxacin

Treatment:

Drug: Moxifloxacin

Solithromycin

Experimental group

Description:

Intravenous with potential step-down to oral solithromycin

Treatment:

Drug: Solithromycin