Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
- Conditions
- Acute otitis mediaTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2014-004164-38-Outside-EU/EEA
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 38
1. Male or female pediatric subjects age 6 months to 6 years old inclusive.
2. For each subject, the parent(s) or legal guardian(s) must be willing and able to provide written informed consent. Where appropriate, the assent of the subject will also be obtained. Subject’s age and relationship to the parent(s) or legal guardian(s) must be verified and documented.
3. Have clinical signs or symptoms of acute otitis media in at least one ear as follows:
•Purulent otorrhea of less than or equal to (=) 24 hours duration
•At least 2 otoscopic signs of middle ear effusion
•Decreased or absent tympanic membrane mobility by pneumatic otoscopy
•Yellow or white discoloration of tympanic membrane
•Opacification of tympanic membrane (other than scarring)
4. At least 1 indicator of acute inflammation to support the diagnosis of AOM:
•Ear pain, including unaccustomed tugging or rubbing
•Marked redness of tympanic membrane
•Distinct fullness or bulging of tympanic membrane
5. Subjects may be inpatients or outpatients. Subjects or their parent(s) or guardian(s) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 38
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
2. Inability to take oral medications or any condition possibly affecting drug absorption.
3. Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
4. Previously diagnosed disease(s) of immune function.
5. Known or suspected hypersensitivity, or intolerance to azithromycin or other
macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor.
6. Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
7. Any medical condition that could interfere with the evaluation of the study drug and would make the subject unsuitable for enrollment, including: Tympanostomy tubes in place, Otitis externa, evidence of chronic middle ear disease including retraction pockets, cholesteatoma and erforations of the tympanic membrane in the affected ear for less than 24 hours prior to study entry or Mastoiditis.
8. Subjects who have consumed grapefruit or grapefruit containing products within 7 days prior to the dose of study medication, or intending to consume these products during the study.
9. Unwilling or unable to comply with the Life Style Guidelines described in the Protocol of the study.
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: azithromycin following a single dose of either 30 mg/kg IR or 60 mg/kg ER formulation in pediatric subjects with AOM.<br>To evaluate clinical response of azithromycin following a single dose of either 30 mg/kg IR or 60 mg/kg ER formulation in pediatric subjects with AOM.;Main Objective: To compare the pharmacokinetics of azithromycin following a single dose of either 30 milligram per kilogram (mg/kg) IR or 60 mg/kg ER formulation in pediatric subjects with AOM.;Primary end point(s): Area Under the Curve From Time Zero to 72 Hours (AUC72Hours);Timepoint(s) of evaluation of this end point: Predose or 0 to 72 Hours
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: - Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose<br>- Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose<br>- Predose or 0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose<br>- 1,2,3,4,8,24,48,72 hours post-dose<br>- Days 7,8,9 or 10<br>- Baseline up to 28 days;Secondary end point(s): - Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)<br>- Maximum Observed Plasma Concentration (Cmax) of Azithromycin<br>- Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin<br>- Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)<br>- Number of Subjects With a Clinical Response<br>- Adverse Events (AEs) and Serious AEs (SAEs)