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Acute Otitis MediaPhase 2NCT00796224

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

A Phase 2 study testing 60 mg/kg azithromycin ER and 30 mg/kg azithromycin IR in people with Acute Otitis Media, run by Pfizer at 2 sites in Costa Rica.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months to 11 years
Conditions the study is for
Acute Otitis Media
What is being tested?
60 mg/kg azithromycin ER and 30 mg/kg azithromycin IR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
2 sitesCosta Rica
Study dates
Dec 2008to Feb 2009
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Clinical significant other disease.
  • Recent use of investigational drugs, prescription or nonprescription drugs.

Trial locations and contacts

2 sites in 1 country.

Costa Rica2 sites

  • Pfizer Investigational Site

    San José, Provincia de San José, 0000

  • Pfizer Investigational Site

    San José, Provincia de San José

Other trials in Costa Rica

About this study

Official title: A Open Label, Randomized, Single Dose, Parallel Arm Study To Determine Pharmacokinetics Of Azithromycin Following Oral Administration Of Immediate-Release Or Extended-Release Formulation In Pediatric Subjects With Acute Otitis Media

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.

Being tested
60 mg/kg azithromycin ER, 30 mg/kg azithromycin IR
Keywords
azithromycin, pharmacokinetics, pediatrics
Medical subject headings
Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 60 mg/kg azithromycin ERDrug

    Also called Zithromax

    subjects taken 60 mg/kg azithromycin ER

  • 30 mg/kg azithromycin IRDrug

    Also called Zithromax

    subjects taken 30 mg/kg azithromycin IR (Immediate Release)

Study groups in NCT00796224
Study groupRoleWhat they receive
1.Active comparator60 mg/kg azithromycin ER (Extended Release)arm
Receives: Drug: 60 mg/kg azithromycin ER
2.Active comparator30 mg/kg azithromycin IR (Immediate Release) arm
Receives: Drug: 30 mg/kg azithromycin IR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve From Time Zero to 72 Hours (AUC72Hours)

    AUC72 = Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hours.

    Measured: Predose/0 to 72 Hours

Secondary outcomes (6)

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Inf)

    AUCinf = AUClast + (Clast* divided by kel), where AUClast is calculated by Linear-Log trapezoidal method, Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

    Measured: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

  2. Maximum Observed Plasma Concentration (Cmax) of Azithromycin

    Measured: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) and Plasma Decay Half Life (t1/2) of Azithromycin

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one-half.

    Measured: Predose/0, 1, 2, 3, 4, 8, 24, 48, 72 hours post-dose

  4. Serum Concentrations of Azithromycin ER (Test) and Azithromycin IR (Reference)

    Measured: 1,2,3,4,8,24,48,72 hours postdose

  5. Number of Participants With a Clinical Response

    Clinical response was assesed between Days 7 and 10, or when subjects discontinued the study prematurely (if applicable). Response was assessed by the investigator as cure or failure. Cure = Clinical signs and symptoms related to the acute illness have resolved, or clinical improvement is such that no additional therapy is necessary. Failure = One or more of the following:

    • Signs and symptoms related to the acute illness have persisted or worsened and additional therapy is necessary;
    • New clinical signs and symptoms of acute illness have developed and additional therapy is necessary

    Measured: Days 7,8,9 or 10

  6. Adverse Events (AEs) and Serious AEs (SAEs)

    All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) was reported.

    Measured: Baseline up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00796224
Sponsor's protocol ID
A0661190
Status last verified
Feb 2010
First submitted
18 Nov 2008
Last updated
18 Feb 2010
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 60 mg/kg azithromycin ER and 30 mg/kg azithromycin IR in people with Acute Otitis Media, run by Pfizer at 2 sites in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to 72 Hours (AUC72Hours) (time frame: Predose/0 to 72 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00796224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2010; AzTrials last refreshed its copy on 7 Nov 2026.

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