- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00044473
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
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
An Open-Label Study of Levofloxacin to Evaluate Bacteriologic Outcome in the Treatment of Children Who Are at Risk for Acute Otitis Media That is Difficult to Treat
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.
Study Overview
Detailed Description
Rapid and severe onset of middle ear infection is a common bacterial infection in children.
These infections, particularly when they occur early in life and are recurrent, are associated with considerable disease and can lead to increasingly serious infections.
This is a multicenter study to determine the effectiveness of levofloxacin in eliminating bacteria in the middle ear fluid of children between 6 months and 5 years of age 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).
The study consists of a 1-day screening period when patients will be tested for eligibility for the study; a 4 to 6-day treatment, blood collection, possible collection of fluid from the middle ear, and assessment period; and a post-treatment period to assess the status of the middle ear infection.
All patients will receive levofloxacin 2 times daily (up to a maximum daily dose of 500 mg) mixed with liquid and taken by mouth for 10 days.
Safety evaluations will include laboratory tests, physical examinations, vital sign measurements, and recording of adverse events, including any report of joint pain or signs and symptoms of joint disease.
Effectiveness will be assessed by the rate of elimination of the bacteria identified at the start of the study and by signs and symptoms, as well as microscopic evidence that the patient is cured of the middle ear infection.
The study hypothesis is that levofloxacin will be effective in eliminating bacteria in the middle ear fluid of children with a rapid and severe onset of infection and inflammation of the middle ear and who are at high risk for infections that are difficult to treat.
Levofloxacin 10 milligrams/kilogram (mg/kg) 2 times daily (up to a maximum daily dose of 500 mg) mixed with liquid and taken by mouth for 10 days
Study Type
Interventional
Enrollment (Actual)
206
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Rate of elimination of the disease-producing bacteria identified at the start of the study; signs and symptoms and microscopic evidence of cure
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion
December 7, 2022
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
August 29, 2002
First Submitted That Met QC Criteria
September 3, 2002
First Posted (Estimate)
September 4, 2002
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Otorhinolaryngologic Diseases
- Ear Diseases
- Otitis
- Otitis Media
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Levofloxacin
- Ofloxacin
Other Study ID Numbers
- CR002389
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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