Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034736
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
A Study to Compare the Efficacy and Safety of Levofloxacin in the Treatment of Children With Community-acquired Pneumonia in the Hospital or Outpatient Setting
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Open-Label Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia
Detailed Description:
This is a multicenter study to determine the efficacy of levofloxacin compared with the standard of care antibiotic medication commonly used for the treatment of infection in question in treating community acquired pneumonia in children aged 6 months to 16 years The study consists of 4 phases a 1-day screening period when patients will be tested for eligibility for the study 10-day treatment blood collection and evaluation period a post-treatment period beginning 1 to 3 days after the last dose of the study medication and a post-study period 10 to 17 days after the last dose of study medication to assess whether the patient has been cured of pneumonia Patients will be divided into 2 groups based upon age and then randomly assigned to receive up to 10 days of either levofloxacin or another antibiotic The patients in Group 1 will be randomly assigned to levofloxacin or amoxicillinclavulanate The patients in Group 2 will be randomly assigned to receive levofloxacin or either ceftriaxone plus erythromycin lactobionate or clarithromycin Safety evaluations will include laboratory tests physical examinations vital sign measurements and recording of adverse events including any adverse events affecting muscles or bones Efficacy assessments include whether the patient was cured of pneumonia based on signs and symptoms of pneumonia reported before the start of the study Additionally at both the post-therapy and the post-study visits responses will be evaluated by patients signs and symptoms and by microscopic examination of the bacteria identified at the start of the study The study hypothesis is that the treatment with levofloxacin will be effective in the treatment of children aged 6 months to 16 years with community acquired pneumonia and wil be well tolerated by the patients Levofloxacin 10 mgkg once or twice daily amoxicillinclavulanate 225 mgkg twice daily ceftriaxone 25 mgkg twice daily plus erythromycin lactobionate 10 mgkg every 6 hours or clarithromycin 75 mgkg twice daily either intravenously or by mouth for up to 10 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None