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

NCT00034736 | Completed Phase 3

• 1 other identifier: CR002392
• Study Type: interventional
• Target: 691
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Keywords

Pneumonia; Bacterial pneumonia; Community acquired pneumonia; Lung Inflammation; Quinolones; Levofloxacin; Ceftriaxone; Erythromycin; Clarithromycin

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.

Secondary Outcomes (1)

• 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.

Interventions

Levofloxacin DRUG

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Publications (1)

• Bradley JS, Arguedas A, Blumer JL, Saez-Llorens X, Melkote R, Noel GJ. Comparative study of levofloxacin in the treatment of children with community-acquired pneumonia. Pediatr Infect Dis J. 2007 Oct;26(10):868-78. doi: 10.1097/INF.0b013e3180cbd2c7.

  PMID: 17901791 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Pneumonia; Pneumonia, Bacterial; Community-Acquired Pneumonia

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Community-Acquired Infections

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 2, 2002
• First Posted: May 3, 2002
• Study Start: August 1, 2002
• Study Completion: June 1, 2004
• Last Updated: June 8, 2011

Record last verified: 2010-12