Study to Measure the Impact of Antibiotics on Bacterial Flora in Adults With Acute Sinusitis

NCT00245440 | Terminated Phase 4

• 1 other identifier: HMR3647A-6045
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).

Conditions

Maxillary Sinusitis

Keywords

S.pneumonia; sinusitis; ams; azithromycin

Outcome Measures

Primary Outcomes (1)

• Bacterial resistance or selection

  42 days

Secondary Outcomes (1)

• Bacteriologic outcome

  42 days

Study Arms (2)

1

ACTIVE COMPARATOR

Subjects assigned Azithromycin

Drug: Azithromycin

2

ACTIVE COMPARATOR

Subjects assigned Telithromycin

Drug: Telithromycin

Interventions

Azithromycin DRUG

250 mg tablets; 2 tablets once daily (500 mg) for 3 days

1

Telithromycin DRUG

400 mg tablets; 2 tablets once daily (800 mg) for 5 days

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx.
• Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage.
• All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture.
• Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device \[IUD\]). The patient must agree to continue with the same method throughout the study.

You may not qualify if:

• Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months
• Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days
• Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks)
• Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days
• Patients who are long-term (\> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%)
• Patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic
• Impaired hepatic or renal function (creatinine clearance \[CCL\] \<20 ml/min)
• Severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy.
• Requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents.
• Treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.

Sponsors & Collaborators

• CPL Associates: lead
• Sanofi: collaborator

Study Sites (1)

Southeastern Researchs Associates,Inc.

Taylors, South Carolina, 29687, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Maxillary Sinusitis; Sinusitis; Focal Facial Dermal Dysplasias

Interventions

Azithromycin; telithromycin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ectodermal Dysplasia; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Jerome J Schentag, Pharm.D.

  State University of NY at Buffalo

  PRINCIPAL INVESTIGATOR

• Joseph Paladino, Pharm.D.

  State University of NY at Buffalo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2005
• First Posted: October 28, 2005
• Study Start: December 1, 2005
• Study Completion: July 1, 2006
• Last Updated: October 31, 2007

Record last verified: 2007-10

Locations

US (1)