Healthy VolunteerPhase 1NCT00821782
Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications
A Phase 1 study testing Levofloxacin; Azithromycin in people with Healthy Volunteer, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
Trial summary
Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin, floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then periodically for 6 weeks after the last dose of study drug is taken Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Levofloxacin; Azithromycin
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Sep 2006
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Healthy on the basis of a pre-study physical examination, medical history, and the laboratory results of blood hematology, biochemistry, and urinalysis performed within 24 hours before the first dose
- Renal function tests must be within the normal laboratory reference ranges
- Normotensive with sitting (5 minutes) blood pressure between the range of 90 to 140 mmHg systolic, inclusive, and 50-90 mmHg diastolic, inclusive
- Normal temperature for at least 72 hours. Normal defined as >36.0 C (96.8 F) to <37.5 C (99.5 F)
- Weight as defined by BMI range of 18 to 32 kg/m2, inclusive
- Must have read and signed the informed consent document before the first study-related procedure indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Who cannot join
- History of allergy or serious adverse reaction to levofloxacin or any other quinolone or to azithromycin or any other macrolide
- Clinically significant abnormal laboratory values
- Previous systemic antimicrobial therapy within 3 months of Study Entry for any reason
- Hospitalized for any cause within 3 months prior to Study Entry
- Current drug abuse, alcohol abuse, or homelessness
- Requirement for any prescription or non-prescription medication or supplements such as vitamins and herbal supplements, except for paracetamol (acetaminophen) for the treatment of headache and other pain, hormone replacement therapy, and birth control medication upon study entry and during study conduct
- Pregnancy or breastfeeding
- Has received an experimental drug or medical device within the previous 3 months or involvement in any other experimental protocol.
About this study
Official title: A Randomized, Open-Label Study Comparing Levofloxacin Once-Daily 750 mg PO for 5 Days and Azithromycin Once-Daily 500 mg on Day One and Then 250 mg Days 2 Through 5 In a Microbiologic Evaluation for Emergence of Resistance in the Oropharyngeal Flora of Healthy Subjects
Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin, floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then periodically for 6 weeks after the last dose of study drug is taken
Read the detailed description
This is a randomized, open-label, single center, exploratory, Phase 1 study to explore changes and resistance patterns of bacteria in the oral flora of healthy male and female adult subjects. The study is to enroll approximately 140 healthy subjects. Approximately 70 subjects are to receive levofloxacin once daily for 5 days and 70 are to receive azithromycin once daily for 5 days. Male or female healthy subjects, 18 years or older may participate. Subjects will be treated on an outpatient basis at a Phase 1 facility. Laboratory testing (blood and urine collection) and microbiologic testing (throat swab) will be performed before dosing with study drug at the Study Entry (Visit 1). Subjects will return daily to the testing facility for their once-daily dosing of study drug for Visits 2 through 5 for a total of 5 consecutive days. At Visit 5 laboratory and microbiologic testing will be performed. Subjects will again return to the testing facility for the 2-Week (Visit 6), 4-Week (Visit 7) and 6-Week (Visit 8) Post-Therapy Visits to undergo microbiologic testing (throat swab). The primary endpoint is the emergence of bacterial resistance in the oropharyngeal flora starting prior to the initiation of study drug through a 6-week observation period. Microbiologic testing (throat swab) will be conducted prior to dosing on Day 1 and following dosing on Days 5, 19, 33, and 47. Safety assessments will be conducted prior to drug administration, during study drug treatment, and at the end-of-therapy visit. These included clinical laboratory evaluations, vital signs, physical examinations, pregnancy testing, and collection of adverse events. Serious adverse events will be collected for 30 days following the last dose of study drug. Levofloxacin Once-Daily 750 mg PO For 5 Days And Azithromycin Once-Daily 500 mg PO On Day One And Then 250 mg On Days 2 Through 5
- Conditions
- Healthy Volunteer
- Being tested
- Levofloxacin; Azithromycin
- Keywords
- Bacteria, Oral flora bacteria, Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin; AzithromycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the emergence or worsening of bacterial resistance in the mouth and throat through six weeks after completion of the antibiotic
Secondary outcomes (1)
All bacterial species cultured from the mouth and throat will be recorded. Each bacterial species seen at baseline, the proportion of subjects in which there was bacterial resistance will be summarized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startJun 2006
- Study completionSep 2006
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 Healthy VolunteerStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821782
- Sponsor's protocol ID
- CR012235
- Status last verified
- Apr 2010
- First submitted
- 9 Jan 2009
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Nord CE, Peterson J, Ambruzs M, Fisher AC. Levofloxacin versus azithromycin on the oropharyngeal carriage and selection of antibacterial- resistant streptococci in the microflora of healthy adults. Curr Med Res Opin. 2009 Jun;25(6):1461-7. doi: 10.1185/03007990902953468.
PubMed 19419343
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study Comparing Levofloxacin Once-Daily 750 mg PO for 5 Days and Azithromycin Once-Daily 500 mg on Day One and Then 250 mg Days 2 Through 5 In a Microbiologic Evaluation for Emergence of Resistance in the Oropharyngeal Flora of Healthy Subjects
- ClinicalTrials.gov ID
- NCT00821782
- Acronym / sponsor ID
- CR012235
- Conditions
- Healthy Volunteer
- Keywords
- Bacteria, Oral flora bacteria, Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 13 Jan 2009 (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.
Evaluation of bacteria in the mouth and throat before study drug ( Levofloxacin, floroquinolone antibiotic and Azithromycin, a macrolide antibiotic) is started and then periodically for 6 weeks after the last dose of study drug is taken
Detailed description
This is a randomized, open-label, single center, exploratory, Phase 1 study to explore changes and resistance patterns of bacteria in the oral flora of healthy male and female adult subjects. The study is to enroll approximately 140 healthy subjects. Approximately 70 subjects are to receive levofloxacin once daily for 5 days and 70 are to receive azithromycin once daily for 5 days. Male or female healthy subjects, 18 years or older may participate. Subjects will be treated on an outpatient basis at a Phase 1 facility. Laboratory testing (blood and urine collection) and microbiologic testing (throat swab) will be performed before dosing with study drug at the Study Entry (Visit 1). Subjects will return daily to the testing facility for their once-daily dosing of study drug for Visits 2 through 5 for a total of 5 consecutive days. At Visit 5 laboratory and microbiologic testing will be performed. Subjects will again return to the testing facility for the 2-Week (Visit 6), 4-Week (Visit 7) and 6-Week (Visit 8) Post-Therapy Visits to undergo microbiologic testing (throat swab). The primary endpoint is the emergence of bacterial resistance in the oropharyngeal flora starting prior to the initiation of study drug through a 6-week observation period. Microbiologic testing (throat swab) will be conducted prior to dosing on Day 1 and following dosing on Days 5, 19, 33, and 47. Safety assessments will be conducted prior to drug administration, during study drug treatment, and at the end-of-therapy visit. These included clinical laboratory evaluations, vital signs, physical examinations, pregnancy testing, and collection of adverse events. Serious adverse events will be collected for 30 days following the last dose of study drug. Levofloxacin Once-Daily 750 mg PO For 5 Days And Azithromycin Once-Daily 500 mg PO On Day One And Then 250 mg On Days 2 Through 5
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- Healthy on the basis of a pre-study physical examination, medical history, and the laboratory results of blood hematology, biochemistry, and urinalysis performed within 24 hours before the first dose
- Renal function tests must be within the normal laboratory reference ranges
- Normotensive with sitting (5 minutes) blood pressure between the range of 90 to 140 mmHg systolic, inclusive, and 50-90 mmHg diastolic, inclusive
- Normal temperature for at least 72 hours. Normal defined as >36.0 C (96.8 F) to <37.5 C (99.5 F)
Key exclusion criteria (8 listed)
- History of allergy or serious adverse reaction to levofloxacin or any other quinolone or to azithromycin or any other macrolide
- Clinically significant abnormal laboratory values
- Previous systemic antimicrobial therapy within 3 months of Study Entry for any reason
- Hospitalized for any cause within 3 months prior to Study Entry
- Current drug abuse, alcohol abuse, or homelessness
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; Azithromycin | Drug | – |
Primary outcome
The primary endpoint is the emergence or worsening of bacterial resistance in the mouth and throat through six weeks after completion of the antibiotic
1 secondary outcome
All bacterial species cultured from the mouth and throat will be recorded. Each bacterial species seen at baseline, the proportion of subjects in which there was bacterial resistance will be summarized.
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 19 May 2011.
- Derived from this study: PubMed 19419343Nord CE, Peterson J, Ambruzs M, Fisher AC. Levofloxacin versus azithromycin on the oropharyngeal carriage and selection of antibacterial- resistant streptococci in the microflora of healthy adults. Curr Med Res Opin. 2009 Jun;25(6):1461-7. doi: 10.1185/03007990902953468.
- N OPEN-LABEL RANDOMIZED STUDY COMPARING LEVOFLOXACIN 750 MG/DAY FOR 5 DAYS AND AZITHROMYCIN 500 MG ON DAY 1 AND 250MG ON DAYS 2-5 IN A MICROBIOLOGIC EVALUATION FOR EMERGENCE OF BACTERIAL RESISTANCE IN HEALTHY SUBJECTS' OROPHARYNGEAL FLORALink 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.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levofloxacin; Azithromycin in people with Healthy Volunteer, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
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 7 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 19 May 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The primary endpoint is the emergence or worsening of bacterial resistance in the mouth and throat through six weeks after completion of the antibiotic. 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 NCT00821782, 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 19 May 2011.