Phase 2
Completed N=38
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
Source: ClinicalTrials.gov NCT00796224 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) — 12173.023; 7950.949 ng*hr/ml
Summary
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) |
12173.023; 7950.949 | — |
| SECONDARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf) |
15536.196; 9645.630 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Azithromycin |
774.750; 901.644 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin |
3.0; 2.0; 30.303; 28.959 | — |
| SECONDARY Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference) |
99.96; 152.75; 293.14; 579.72; 381.96; 381.69 | — |
| SECONDARY Number of Participants With a Clinical Response |
18; 16; 0; 2 | — |
| SECONDARY Adverse Events (AEs) and Serious AEs (SAEs) |
4; 5; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects age 6 months to < 12 years.
- Have clinical signs/symptoms of acute otitis media in at least one ear.
- Parent(s)/legal guardian(s) provide written informed consent.
Exclusion Criteria
- Clinical significant other disease.
- Recent use of investigational drugs, prescription or nonprescription drugs.
Data sourced from ClinicalTrials.gov (NCT00796224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.