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

Melinta Therapeutics

Status and phase: Completed; Phase 3

Conditions: Community-acquired Bacterial Pneumonia

Treatments: Drug: Moxifloxacin; Other: Placebo to match solithromycin; Drug: Solithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01756339

CE01-300

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: 860 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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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860 participants in 2 patient groups

Solithromycin

Experimental group

Description:

Solithromycin 800 mg orally (PO) on Day 1 followed by 400 mg PO daily on Days 2 through 5, followed by placebo on Days 6 and 7

Treatment:

Drug: Solithromycin

Other: Placebo to match solithromycin

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin 400 mg PO daily on Day 1 through Day 7

Treatment:

Drug: Moxifloxacin