Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications
Information source: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Volunteer
Intervention: Levofloxacin; Azithromycin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC Official(s) and/or principal investigator(s): Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Locations and Contacts
Additional Information
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 FLORA
Starting date: June 2006
Last updated: May 18, 2011
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