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Completed

NCT Number: NCT01968733

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

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

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Key information

Conditions

Community-acquired Bacterial Pneumonia Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Caba, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • Cough
  • Production of purulent sputum
  • Shortness of breath (dyspnea)
  • Chest pain due to pneumonia
  • At least 1 of the following:
  • Fever
  • Hypothermia
  • 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

Treatment and study plan

Solithromycin

Drug

Other names: CEM-101

moxifloxacin

Drug

Other names: Avelox

Primary outcomes

  1. Early clinical response rate in the Intent to Treat (ITT) population.

    Time frame: 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 outcomes

  1. Early clinical response rate in the microITT population

    Time frame: 72 [±12] hours after the first dose of study drug

    To determine NI in early clinical response rate of intravenous to oral solithromycin compared to intravenous to oral moxifloxacin in the mITT population

  2. Clinical success rates in the ITT and Clinically Evaluable (CE) populations

    Time frame: 5 to 10 days after the last dose of study drug

    To determine the overall clinical success rates of intravenous to oral solithromycin compared to moxifloxacin

Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients With Community-Acquired Bacterial Pneumonia

Acronym: SOLITAIRE-IV

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 24, 2013
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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