Clinical Trials Logo
  1. Home
  2. Otitis Media
  3. NCT00768534
  4. Details
NCT00768534 Clinical Trial

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

Otitis Media Clinical Trial

Official title:
Microbiological Analysis Of Spontaneous Draining Acute Otitis Media Including Serotype Distribution Of Pneumococcal Isolates

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00768534
Other study ID # 0887X1-4454
Secondary ID B1841014
Status Completed
Phase N/A
First received October 7, 2008
Last updated October 5, 2016
Start date October 2008
Est. completion date October 2015

Study information
Verified date October 2016
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Observational

Clinical Trial Summary

Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

Recruitment information / eligibility
Status Completed
Enrollment 2138
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 5 Years
Eligibility Inclusion Criteria:

Main inclusion criteria:

- Children >= 2 months and =< 5 years

- Spontaneous draining AOM =< 2 days Main

Exclusion Criteria:

exclusion criteria:

- Previous operation of the ear

- Chronic otitis media or tube placement with drainage >= 3 days

- Chronic disease/immune deficiency

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Dr. Andreas Busse Tegernsee Bavarian

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary serotype distribution 30 days No
See also
  Status Clinical Trial Phase
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02452164 - Family MobilePhone Otoscopy in Diagnostics of Otitis Media N/A
Completed NCT01199016 - Effect of Prevnar 13 on Ear Infections in Children Phase 4
Terminated NCT00778063 - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Recruiting NCT03722160 - Clinical Study of the Solo Tympanostomy Tube Device N/A
Recruiting NCT04447521 - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Completed NCT02600559 - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes Phase 3
Completed NCT01444391 - inVENT-visIOn Study N/A
Enrolling by invitation NCT01437436 - The Effect of Obesity on Ventilation Tube Insertion N/A
Completed NCT01003210 - Homeopathic Ear Drops for Otitis Media Study N/A
Recruiting NCT00393159 - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Phase 4
Completed NCT00617682 - Maternal Immunization To Prevent Infant Otitis Media Phase 1/Phase 2
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Withdrawn NCT01908764 - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery Phase 1
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT02616458 - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population N/A
Completed NCT00051753 - Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media Phase 3
Completed NCT00044473 - A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat Phase 3

External Links