The primary objective of this study was to evaluate the clinical efficacy of treatment with Nemonoxacin compared with Tavanic® in patients with community-acquired pneumonia (CAP).
Treatment-naive patients with CAP and patients with treatment failure were screened and if met the eligible criteria were randomized to receive either treatment with investigational product or comparator. Patients started to receive intravenous therapy with Nemonoxacin or Tavanic® and then upon a decision of investigator patients were switched to oral therapy with the same product. Intravenous therapy included two consequence infusions (antibiotic solution and placebo solution) to maintain blinding. Intravenous therapy should have been given for at least 3 days and could have been prolonged by a decision of investigator up to 7 days. Then investigator switched a patient from intravenous to oral therapy on Day 4(8) of the study if the specific criteria of clinical stability were achieved. To maintain blinding during oral antibiotic therapy each Tavanic® tablet was placed into a capsule shell (over-encapsulated), that was identical in appearance to a Nemonoxacin-containing capsules. The average duration of treatment (including intravenous and oral therapy) for each patient was 7(14) days and during this period patients should have stayed at hospital. After completion of the treatment patients could have been discharged from the hospital and returned for examinations within 1-2 days after the last dose (end of treatment visit). Then the patients attended the investigational site within 7-9 days after the last dose (test of cure visit). Then the investigator contacted the patients by phone within 21-23 days after the last dose (long-term follow-up visit).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
342
Solution for infusion, 500 mg (250 ml)
Capsules, 250 mg
Solution for infusion, 500 mg (100 ml)
Regional budget healthcare institution "Ivanovo regional clinical hospital"
Number of Patients With Clinical Success as Judged by the Investigator
Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy; chest roentgenograms (CT scans) are cured or improved
Time frame: Visit 4 (within 7-9 days after last dose)
Number of Patients With Clinical Success as Judged by the Investigator
Clinical response is evaluated as clinical success if: all signs and symptoms of pneumonia are resolved or improved with no worsening or appearance of new signs and symptoms of pneumonia; there is no requirement for additional antibiotic therapy
Time frame: Visit 2(day 4/8 ot treatment), Visit 3 (within 1-2 days after last dose)
Number of Patients With Infection Relapse
Time frame: Visit 5 (within 21-23 days after last dose)
Time to Switch Therapy From Intravenous to Oral Therapy
Time frame: Up to Visit 2 (day 4/8 ot treatment)
Number of Patients Required for Other Antibiotic Treatment
Time frame: Up to 21-23 days after last dose
Number of Patients With Microbiological Success
Microbiological response is evaluated as microbiological success if culture study demonstrates eradication of pathogen or no material available for culture because of clinical success
Time frame: Visit 2 (day 4/8 ot treatment), 3 (within 1-2 days after last dose), 4 (within 7-9 days after last dose)
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Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg
0.9% NaCl (250 ml), solution for infusion
0.9% NaCl (100 ml), solution for infusion
Ivanovo, Russia
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