PneumoniaPhase 3NCT00034736
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
A Phase 3 study testing Levofloxacin in people with Pneumonia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Levofloxacin
- How many people
- 691 participants
- Where
- No sites listed yet
- Study dates
- Aug 2002to Jun 2004
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
Official title: A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
The purpose of this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
Read the detailed description
This is a multicenter study to determine the efficacy of levofloxacin compared with the "standard of care" (antibiotic medication commonly used for the treatment of infection in question) in treating community acquired pneumonia in children aged 6 months to 16 years. The study consists of 4 phases: a 1-day screening period when patients will be tested for eligibility for the study; 10-day treatment, blood collection, and evaluation period; a post-treatment period beginning 1 to 3 days after the last dose of the study medication; and a post-study period 10 to 17 days after the last dose of study medication to assess whether the patient has been cured of pneumonia. Patients will be divided into 2 groups based upon age and then randomly assigned to receive up to 10 days of either levofloxacin or another antibiotic. The patients in Group 1 will be randomly assigned to levofloxacin or amoxicillin/clavulanate. The patients in Group 2 will be randomly assigned to receive levofloxacin or either ceftriaxone plus erythromycin lactobionate or clarithromycin. Safety evaluations will include laboratory tests, physical examinations, vital sign measurements, and recording of adverse events, including any adverse events affecting muscles or bones. Efficacy assessments include whether the patient was cured of pneumonia based on signs and symptoms of pneumonia reported before the start of the study. Additionally, at both the post-therapy and the post-study visits, responses will be evaluated by patients' signs and symptoms and by microscopic examination of the bacteria identified at the start of the study. The study hypothesis is that the treatment with levofloxacin will be effective in the treatment of children aged 6 months to 16 years with community acquired pneumonia and wil be well tolerated by the patients. Levofloxacin 10 mg/kg once or twice daily, amoxicillin/clavulanate 22.5 mg/kg twice daily, ceftriaxone 25 mg/kg twice daily plus erythromycin lactobionate 10 mg/kg every 6 hours or clarithromycin 7.5 mg/kg twice daily, either intravenously or by mouth for up to 10 days.
- Conditions
- Pneumonia
- Being tested
- Levofloxacin
- Keywords
- Pneumonia, Bacterial pneumonia, Community acquired pneumonia, Lung Inflammation, Quinolones, Levofloxacin, Ceftriaxone, Erythromycin, Clarithromycin
- Medical subject headings
- Pneumonia, Pneumonia, Bacterial, Community-Acquired Pneumonia
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.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startAug 2002
- Study completionJun 2004
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 PneumoniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 691 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
- NCT00034736
- Sponsor's protocol ID
- CR002392
- Status last verified
- Dec 2010
- First submitted
- 2 May 2002
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
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.
PubMed 17901791
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
- A Multicenter, Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of Levofloxacin and Standard of Care Therapy in the Treatment of Children With Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
- ClinicalTrials.gov ID
- NCT00034736
- Acronym / sponsor ID
- CR002392
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Bacterial pneumonia, Community acquired pneumonia, Lung Inflammation, Quinolones, Levofloxacin, Ceftriaxone, Erythromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2002
- Study completion
- Jun 2004 (actual)
- First posted
- 3 May 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 this study is to determine the safety and efficacy of levofloxacin in the treatment of children with community acquired pneumonia.
Detailed description
This is a multicenter study to determine the efficacy of levofloxacin compared with the "standard of care" (antibiotic medication commonly used for the treatment of infection in question) in treating community acquired pneumonia in children aged 6 months to 16 years. The study consists of 4 phases: a 1-day screening period when patients will be tested for eligibility for the study; 10-day treatment, blood collection, and evaluation period; a post-treatment period beginning 1 to 3 days after the last dose of the study medication; and a post-study period 10 to 17 days after the last dose of study medication to assess whether the patient has been cured of pneumonia. Patients will be divided into 2 groups based upon age and then randomly assigned to receive up to 10 days of either levofloxacin or another antibiotic. The patients in Group 1 will be randomly assigned to levofloxacin or amoxicillin/clavulanate. The patients in Group 2 will be randomly assigned to receive levofloxacin or either ceftriaxone plus erythromycin lactobionate or clarithromycin. Safety evaluations will include laboratory tests, physical examinations, vital sign measurements, and recording of adverse events, including any adverse events affecting muscles or bones. Efficacy assessments include whether the patient was cured of pneumonia based on signs and symptoms of pneumonia reported before the start of the study. Additionally, at both the post-therapy and the post-study visits, responses will be evaluated by patients' signs and symptoms and by microscopic examination of the bacteria identified at the start of the study. The study hypothesis is that the treatment with levofloxacin will be effective in the treatment of children aged 6 months to 16 years with community acquired pneumonia and wil be well tolerated by the patients. Levofloxacin 10 mg/kg once or twice daily, amoxicillin/clavulanate 22.5 mg/kg twice daily, ceftriaxone 25 mg/kg twice daily plus erythromycin lactobionate 10 mg/kg every 6 hours or clarithromycin 7.5 mg/kg twice daily, either intravenously or by mouth for up to 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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
Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.
1 secondary outcome
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.
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 17901791Bradley 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.
- A study to compare the efficacy and safety of levofloxacin in the treatment of children with community-acquired pneumonia in the hospital or outpatient settingLink 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 Pneumonia, 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 5 inclusion and 16 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?
Clinical cure rate (cured or not cured) at 10-17 days after the last dose of study medication.. 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 NCT00034736, 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.