Otitis MediaNCT00250900
Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
A study testing Prescription Fill Status in people with Otitis Media, run by Yale University at 1 site in United States.
Trial summary
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- Prescription Fill Status
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years
- All sexes
- Child
Who may be able to join
- Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media
Who cannot join
- clinician suspicion or diagnosis of a concurrent bacterial infection
- patient appeared "toxic" as determined by the PEM clinician
- patient was hospitalized
- history of compromised immunity
- patient was treated with antimicrobials in the preceding seven days
- either tympanic membrane was perforated
Show all 10Show fewer
- myringotomy tubes were present
- uncertain access to medical care
- primary language of the parent or guardian was neither English nor Spanish
- prior enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription
Read the detailed description
We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.
- Conditions
- Otitis Media
- Being tested
- Prescription Fill Status
- Keywords
- Otitis, Antibiotic, Prescription
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescription Fill StatusBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of each group that filled the antibiotic prescription
Secondary outcomes (1)
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startJul 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- David M Spiro, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250900
- Sponsor's protocol ID
- WASPYALE2005
- Other IDs
- #AI01703 NIH, #MO1-RR00125 GCRC
- Status last verified
- Nov 2005
- First submitted
- 7 Nov 2005
- Last updated
- 30 Nov 2006
- Results posted
- No
Publications
Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235.
PubMed 16968847
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wait and See Antibiotic Prescription for Acute Otitis Media: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00250900
- Acronym / sponsor ID
- WASPYALE2005
- Conditions
- Otitis Media
- Keywords
- Otitis, Antibiotic, Prescription
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Jul 2004
- Study completion
- Aug 2005
- First posted
- 8 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if a wait and see prescription for ear infections in childhood reduces use of antibiotics compared to an immediate prescription
Detailed description
We conducted a randomized, controlled trial evaluating a consecutive series of children diagnosed with AOM during a one year period in an urban pediatric emergency department, utilizing diagnostic recommendations from contemporary evidence-based guidelines. The objectives of the study were to determine whether treatment of AOM using a "Wait and See Prescription" (WASP) significantly reduces use of antimicrobials compared with a "Standard Prescription" (SP) and to evaluate the effects of this intervention on clinical symptoms and adverse outcomes related to antibiotic use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media
Key exclusion criteria (10 listed)
- clinician suspicion or diagnosis of a concurrent bacterial infection
- patient appeared "toxic" as determined by the PEM clinician
- patient was hospitalized
- history of compromised immunity
- patient was treated with antimicrobials in the preceding seven days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prescription Fill Status | Behavioural | – |
Primary outcome
Proportion of each group that filled the antibiotic prescription
1 secondary outcome
Clinical course of the illness; side effects of medications; days of school/work missed; unscheduled medical visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2006.
- Results publication: PubMed 16968847Spiro DM, Tay KY, Arnold DH, Dziura JD, Baker MD, Shapiro ED. Wait-and-see prescription for the treatment of acute otitis media: a randomized controlled trial. JAMA. 2006 Sep 13;296(10):1235-41. doi: 10.1001/jama.296.10.1235.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Spiro, MD, MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescription Fill Status in people with Otitis Media, run by Yale University at 1 site in United States.
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 1 inclusion and 10 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 30 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of each group that filled the antibiotic prescription. 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 NCT00250900, which also lists 1 linked publication.
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 30 Nov 2006.