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Phase 2 N=207 Randomized Double-blind Treatment

Study to Evaluate the Efficacy and Safety of Intravenous Infusion With Nemonoxacin Malate Sodium Chloride

Pneumonia

Enrolled (actual)
207
Serious AEs
2.4%
Results posted
Feb 2015
Primary outcome: Primary: Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population — 60; 58; 59; 7 participants — p=0.133

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Nemonoxacin 500 mg (Drug); Nemonoxacin 650 mg (Drug); Moxifloxacin 400 mg (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
TaiGen Biotechnology Co., Ltd.
Primary completion
Dec 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the mITT Population
60; 58; 59; 7; 4; 2 0.133
SECONDARY
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 4 in the Clinically Evaluable (CE) Population
56; 56; 58; 7; 3; 2 0.118
SECONDARY
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the mITT Population
61; 60; 59; 4; 4; 2 0.456
SECONDARY
Difference in the Clinical Cure Rate of Two Doses of Intravenously Infused Nemonoxacin Malate Sodium Chloride Injection at Visit 3 in the CE Population
58; 56; 56; 4; 3; 2 0.458
SECONDARY
Subject Number for Microbiologically Cured and Failure at Visit 4 in b-mITT (Bacteriological mITT) Population
21; 17; 16; 3; 1; 0 0.959
SECONDARY
Subject Number for Microbiologically Cured and Failure at Visit 4 in BE (Bacteriological Evaluable) Population
20; 17; 15; 3; 1; 0 0.960
SECONDARY
Subject Number for Microbiologically Cured and Failure at Visit 3 in b-mITT (Bacteriological mITT) Population
22; 18; 16; 2; 1; 0 0.950
SECONDARY
Subject Number for Microbiologically Cured and Failure at Visit 3 in BE (Bacteriological Evaluable) Population
21; 18; 16; 2; 1; 0 0.949
SECONDARY
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in b-mITT (Bacteriological mITT) Population
21; 17; 16; 3; 2; 1 0.491
SECONDARY
Subject Number of Success and Failure in Overall Efficacy at Visit 4 in BE (Bacteriological Evaluable) Population
20; 17; 15; 3; 2; 1 0.501
SECONDARY
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in b-mITT (Bacteriological mITT) Population
22; 17; 15; 2; 2; 1 0.807
SECONDARY
Subject Number of Success and Failure in Overall Efficacy at Visit 3 in BE (Bacteriological Evaluable) Population
21; 17; 15; 2; 2; 1 0.779

Summary

The purpose of this study is to Evaluate the Efficacy, safety and pharmacokinetics of Intravenous Nemonoxacin Compared with Intravenous Moxifloxacin in Adult Patients with community-acquired pneumonia (CAP).

Eligibility Criteria

Inclusion Criteria

  • Ages between 18 and 75;
  • Weighs between 40 ~ 100 kg, and BMI ≥ 18 kg/m2;
  • Must have a clinical diagnosis of CAP
  • Chest X-ray and /or CT scan show new or persist/progressive infiltrates
  • Patients with PORT/PSI score II, III or IV.
  • If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
  • The patient is able to receive an intravenous infusion of the drug .

Exclusion Criteria

  • Patients with PORT/PSI score I or VI.
  • Severe CAP is present if a patient needs invasive mechanical ventilation or requires vasopressors.
  • Known or suspected severe bronchiectasis, cystic fibrosis, active pulmonary tuberculosis or infection with other mycobacteria or fungi, known bronchial obstruction, a history of post-obstructive pneumonia, other confounding respiratory diseases, such as lung cancer, malignancy metastatic to the lungs, lung abscess, empyema, suspected aspiration pneumonia due to vomiting, or non-bacterial respiratory infection (chronic obstructive pulmonary disease [COPD] is not exclusionary)
  • Clinically significant conduction or other abnormality on 12-lead ECG, or QTc interval
  • Potassium is < 3.5 mmol/L
  • Any known disease that seriously affect the immune system
  • Active hepatitis or decompensated cirrhosis;
  • Have used quinolones or fluoroquinolones within 14 days before enrollment
  • Patients who are being or will be on a long-term medication of steroids
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01944774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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