An open-label, multi-center trial of azithromycin pharmacokinetics in sinus aspirate and serum following oral administration of either a 500 mg immediate-release (IR) once-daily 3 day regimen or a single-dose 2.0g azithromycin microspheres regimen in subjects with acute bacterial sinusitis.

• Conditions: Acute bacterial sinusitis; MedDRA version: 7.1Level: LLTClassification code 10060841

• Registration Number: EUCTR2005-000639-13-FI
• Lead Sponsor: Pfizer Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Written informed consent of the subject or a legally authorized representative ( as outlined in Appendix A,Section 2.2).

2.Male or female subjects, 18 years of age or older.

3.A clinical diagnosis of acute bacterial sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days but not more than 28 days:

a.Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and

b.Presence of one or more of the following signs:i.purulent nasal dischargeii.purulent drainage in the posterior pharynxiii.purulent discharge from the maxillary sinus orifice

4.A positive sinus x-ray* Waters’ View confirming sinusitis:

For all countries, excluding Germany: A sinus radiograph (X-ray) must show at least one of the following in one or both maxillary sinuses:

a. Complete or partial opacification
b. A =5mm air/fluid level

For Germany only: A sinus radiograph (X-ray), which was performed independently of the trial for clinical reasons (i.e., to diagnose sinusitis), must show at least one of the following in one or both maxillary sinuses:

a.Complete or partial opacification
b. A = 5 mm air/fluid level

*At sites where the local standard of care may require a computerized tomography (CT) scan to confirm, or is needed to make a diagnosis, the CT scan, which confirms the presence of sinusitis may be substituted in place of a sinus X-ray.

5.Two or more of the following clinical signs/symptoms must be present:

a.Fever, as defined by: oral temperature: = 38°C or = 100.4°F, or tympanic temperature: = 38.5°C or = 101.2°F

b.Leukocytosis (WBC >10,000/mm3 or = 15% band forms)

c.Frequent coughing

d.Headache

e.Nasal congestion

f.Post-nasal drainage

6.Subjects must be willing to undergo direct aspiration of the sinus cavity by puncture with the SinoJectTM.

7.Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to start of study medication. Women of childbearing potential must use adequate contraception, defined as hormonal contraception, intrauterine device, or barrier methods (condom or vaginal diaphragm) with spermicide, throughout the study and for four weeks after completion of the study. Women who have been surgically sterilized or are at least two years postmenopausal may be enrolled and do not need to use birth control. Women whose method of birth control is hormonal are required to use an additional barrier method during the study and for one month following the completion of the study.

8.Subjects who are willing and able to comply with scheduled study visits, treatment plan, laboratory tests and other trial procedures.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following will not be included in the trial:

1.Previously diagnosed disease(s) of immune function, including: a.Subjects with a baseline absolute neutrophil count less than and equal to 1000/mm,3

b.HIV positive subjects with a CD4 count less than and equal to200/mm3,
and/or

c.Any immunoglobulin or neutrophil disorder.

2.Pregnant or lactating women

3.Abnormal prothrombin time or any other clinically significant laboratory abnormality

4.Concomitant illnesses requiring anti-infective therapy that might interfere with evaluation of a therapeutic response within 5-7 days (azithromycin, ceftriaxone) or 48 hours (any other antibiotic) prior to the baseline visit. Subjects receiving a systemic antifungal or antiviral agent for prophylaxis or for treatment of a non respiratory infection (e.g., for vaginal yeast infection or HSV) are eligible for study entry and may continue those medications.5.Gastrointestinal disturbances that might affect drug absorption (e.g., malabsorption syndromes, peptic ulcer, acute diarrhea)

6.Symptoms of sinusitis( including those decribed in the inclusion criteria above) lasting longer than 28 days.

7.Four or more episodes of acute sinusitis within the preceding 12 months or a history of chronic sinusitis or allergic fungal sinusitis

8.Nasal or sinus surgery within three months prior to enrollment other than for a diagnostic procedure

9.Complicated rhinosinusitis (e.g., osteomyelitis, Pott’s puffy tumor, malignancy involving the sinus, or the requirement for reconstructive surgery). Subjects with significant nasal obstruction due to septal deviation or nasal polyposis.

10.Subjects who are currently hospitalized for any reason

11.Nosocomial rhinosinusitis

12.Diagnosis of cystic fibrosis

13.Severe renal insufficiency (creatinine clearance CrCl, <30 ml/min)

14.Known or suspected hepatic disease

15.Treatment with an investigational drug within 30 days prior to trial enrollment.

16.Prior enrollment in either this or any trial utilizing azithromycin microspheres.

17.Subjects who regularly takes magnesium or aluminum containing antacids.

18.Subjects taking any immunosuppressant medication, coumadin or other anticoagulant medication (e.g., aspirin and other non-steroidal anti-inflammatory drugs).

19.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of the trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.

20.Positive urine drug screen. Subjects with history or are current abusers of alcohol and/or other drugs.

21.Know or suspected hypersensitivity or intolerance to any macrolide-like compound, including erythromycin, clarithromycin, and azithromycin.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified