Evaluation of Bacteria in the Mouth and Throat of Healthy Adults Before and After the Administration of Either Levofloxacin or Azithromycin, Both Antibiotic Medications

NCT00821782 | Completed Phase 1

• 1 other identifier: CR012235
• Study Type: interventional
• Target: 143
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Healthy Volunteer

Keywords

Bacteria; Oral flora bacteria; Resistance

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Levofloxacin; Azithromycin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Related Publications (1)

• 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.

  PMID: 19419343 DERIVED

Related Links

• 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

MeSH Terms

Interventions

Levofloxacin; Azithromycin

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: June 1, 2006
• Study Completion: September 1, 2006
• Last Updated: May 19, 2011

Record last verified: 2010-04