Otitis MediaPhase 3NCT00044473
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
A Phase 3 study testing levofloxacin in people with Otitis Media, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- levofloxacin
- How many people
- 206 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jul 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Otitis Media
- Being tested
- levofloxacin
- Keywords
- Otitis Media, Ear Diaeases, Levofloxacin, Quinolones
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levofloxacinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2002 (estimated)
- Study startNov 2002
- Study completionJul 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044473
- Sponsor's protocol ID
- CR002389
- Status last verified
- Jan 2011
- First submitted
- 29 Aug 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
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.
PubMed 17133154
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00044473
- Acronym / sponsor ID
- CR002389
- Conditions
- Otitis Media
- Keywords
- Otitis Media, Ear Diaeases, Levofloxacin, Quinolones
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Jul 2003 (actual)
- First posted
- 4 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levofloxacin | Drug | – |
Primary outcome
Rate of elimination of the disease-producing bacteria identified at the start of the study; signs and symptoms and microscopic evidence of cure
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 17133154Arguedas 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.
- A Study of Levofloxacin to Evaluate Bacteriologic Outcome in Children with Difficult To Treat Acute Otitis MediaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing levofloxacin in people with Otitis Media, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.