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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00034736 |
Purpose
The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia |
Drug: Levofloxacin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 650 |
| Study Start Date: | March 2002 |
| Estimated Study Completion Date: | June 2004 |
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 amoxicillin/clavulanate. 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 mg/kg once or twice daily, amoxicillin/clavulanate 22.5 mg/kg twice daily, ceftriaxone 25 mg/kg twice daily plus erythromycin lactobionate 10 mg/kg every 6 hours or clarithromycin 7.5 mg/kg twice daily, either intravenously or by mouth for up to 10 days.
Eligibility| Ages Eligible for Study: | 6 Months to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| Study ID Numbers: | CR002392 |
| Study First Received: | May 2, 2002 |
| Last Updated: | October 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00034736 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Levofloxacin Erythromycin Lung Inflammation Community acquired pneumonia Quinolones |
Pneumonia Clarithromycin Ceftriaxone Bacterial pneumonia |
|
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Ofloxacin Enzyme Inhibitors Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |
Anti-Bacterial Agents Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Therapeutic Uses Pneumonia Nucleic Acid Synthesis Inhibitors |