A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat

NCT00044473 | Completed Phase 3

• 1 other identifier: CR002389
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the rate of elimination of bacteria by levofloxacin in middle ear fluid of children with a rapid and severe onset of infection and inflammation of the middle ear who are at high risk for infections that are difficult to treat.

Conditions

Otitis Media

Keywords

Otitis Media; Ear Diaeases; Levofloxacin; Quinolones

Outcome Measures

Primary Outcomes (1)

• Rate of elimination of the disease-producing bacteria identified at the start of the study; signs and symptoms and microscopic evidence of cure

Secondary Outcomes (1)

• Physical examinations including examination of the muscles, joints, and bones; vital sign measurements, laboratory tests, and incidence of adverse events including any report of joint pain or joint disease

Interventions

levofloxacin DRUG

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with signs and symptoms of rapid onset of severe infection of the middle ear defined as: either fluid draining from the middle ear (with a minimum of 2 of the following: decreased or absent eardrum mobility seen on physical examination
• yellow or white discoloration of the eardrum
• opaque eardrum) and (a minimum of 1 of the following: ear pain within 24 hours of the start of the study including the child's unexpected tugging or rubbing of the ear
• marked redness of the eardrum
• distinct fullness or bulging of the eardrum) or rapid onset of severe drainage of pus from the external ear lasting less than 48 hours and not due to inflammation of the external ear
• At risk for difficult-to-treat middle ear infection defined as having a minimum of 1 of the following: recurrent middle ear infection (defined as \>=3 episodes, including the current episode, of rapid onset of rapid onset of severe middle ear infection during the 6 months before the study or \>=4 episodes, including the current episode, of rapid onset of rapid onset of severe middle ear infection during the year before the study), persistent middle ear infection defined by signs and symptoms of rapid onset of severe middle ear infection on the third day after starting any antibiotic treatment (with the exception of amoxicillin/clavulanate that included \>=90 milligrams/kilograms/day \[mg/kg/day\] of amoxicillin)
• Currently taking antibiotic medication to prevent middle ear infection (must be discontinued when beginning the study)
• Completed treatment with an antibiotic intended to treat middle ear infection within 30 days before the start of the study.

You may not qualify if:

• Patients with a history of a previous sensitivity or serious adverse reaction to the type of antibiotic used in this study
• Tubes in place in the affected ear to allow drainage of fluid from the middle ear
• Requirement of antibiotic therapy that affects the whole body, other than the study drug
• A serious bacterial infection in addition to middle ear infection that may interfere with assessment of the patient's response to study medication
• Diagnosis of bacterial meningitis
• 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 concerning muscles or bones
• Chronic use of corticosteroids

Sponsors & Collaborators

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

Related Publications (1)

• Arguedas A, Dagan R, Pichichero M, Leibovitz E, Blumer J, McNeeley DF, Melkote R, Noel GJ. An open-label, double tympanocentesis study of levofloxacin therapy in children with, or at high risk for, recurrent or persistent acute otitis media. Pediatr Infect Dis J. 2006 Dec;25(12):1102-9. doi: 10.1097/01.inf.0000246828.13834.f9.

  PMID: 17133154 DERIVED

Related Links

• A Study of Levofloxacin to Evaluate Bacteriologic Outcome in Children with Difficult To Treat Acute Otitis Media

MeSH Terms

Conditions

Otitis Media

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 29, 2002
• First Posted: September 4, 2002
• Study Start: November 1, 2002
• Study Completion: July 1, 2003
• Last Updated: June 8, 2011

Record last verified: 2011-01