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
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia
Intervention: Levofloxacin (Drug)
Phase: Phase 3
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The purpose of this study is to determine the safety and efficacy of levofloxacin in the
treatment of children with community acquired pneumonia.
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.
Secondary outcome: Clinical response rate (cure or improved response) at 1-3 days after the last dose. Rate of elimination of disease-causing bacteria at 1-3 and 10-17 days after the last dose. Safety evaluations monitored throughout the study.
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.
Minimum age: 6 Months.
Maximum age: 16 Years.
- Signs and symptoms of pneumonia including at least 2 of the following: fever, cough,
chest pain, shortness of breath, physical examination showing lung tissue has become
airless and of solid consistency, white blood cell count >15,000/uL or <5000/uL
(normal range is approximately from 3800/uL to 9800/uL)
- Chest x-ray showing evidence of lung infection
- Production of sputum (not an absolute requirement for enrollment
- However, all reasonable attempts to obtain a sputum specimen should be made
- Parental consent to participate in the study
- Patients who have used antibiotics that affect the whole body for more than 24 hours
immediately before the start of the study
- Requirement of antibiotic therapy that affects the whole body, other than study
- Suspected infection with a bacteria known to be resistant to any of the study drugs
- Signs and symptoms of infection with a bacteria that affects the central nervous
- History of a previous sensitivity or serious adverse reaction to any antibiotic
similar to those used in this study
- History of cystic fibrosis
- Abnormal kidney function, as determined by blood test (serum creatinine)
- History or presence of joint disease or disease of the tissues surrounding joints, or
any other signs or symptoms in muscles or bones that may make it difficult to evaluate
any future complaints concernng muscles or bones
- Hospitalization or residence in a long-term care facility for 14 or more days before
the beginning of pneumonia symptoms
- Infection acquired in a hospital
- Poorly controlled seizure disorder or at significant risk for seizures
- Unstable psychiatric disorder
- Known or highly suspected to be infected tuberculosis
- Known HIV (human immunodeficiency virus) infection requiring treatment to prevent PCP
(pneumocystis carinii pneumonia
- A type of pneumonia that mainly affects those with compromised immune systems)
- Persistent use of corticosteroids
Locations and Contacts
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
Starting date: March 2002
Ending date: June 2004
Last updated: October 11, 2007