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

• Status: Completed
• Trial end date: 2004-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 drug(s)

• 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 system

• 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