Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03551210
Status:
COMPLETED
Last Update Posted:
2023-02-16
First Post:
2018-05-28
Brief Title:
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
An International Multicenter Randomized Double-blind Double-dummy Two-way Parallel Group Controlled Study to Compare the Efficacy and Safety of Intravenous and Oral Nemonoxacin Versus Tavanic in Adult Patients With Community-acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 48 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 714 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
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 48 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 714 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None