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Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children

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ClinicalTrials.gov Identifier: NCT01160055
Recruitment Status : Withdrawn (Key aspects linked to sample management and analysis were not met during feasibility assessment limiting the ability of the study to reach its objectives.)
First Posted : July 12, 2010
Last Update Posted : April 13, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date July 1, 2010
First Posted Date July 12, 2010
Last Update Posted Date April 13, 2015
Study Start Date October 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2010)
Occurrence of bacterial pathogens isolated from middle ear fluid samples. [ Time Frame: 12 Months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01160055 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 8, 2010)
  • Occurrence of bacterial serotypes. [ Time Frame: 12 Months ]
  • Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques. [ Time Frame: 12 Months ]
  • Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media. [ Time Frame: 12 Months ]
  • Occurrence of spontaneous otorrhoea. [ Time Frame: 12 Months ]
  • Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy. [ Time Frame: 12 Months ]
  • Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine. [ Time Frame: 12 Months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
Official Title Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt
Brief Summary The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Middle ear fluid, Urine.
Sampling Method Non-Probability Sample
Study Population Children aged >= 3 months to < 5 years visiting ear, nose and throat specialists for the treatment of acute otitis media.
Condition Infections, Streptococcal
Intervention Procedure: Middle ear fluid and urine.
Middle ear fluid and urine collection.
Study Groups/Cohorts
  • Cohort A
    Subjects with a new episode of Acute Otitis Media (<3 days of onset) who have not yet received antibiotic therapy for the episode.
    Intervention: Procedure: Middle ear fluid and urine.
  • Cohort B
    Subjects who have had a diagnosis of Acute Otitis Media within 2-3 days prior to study enrolment and received antibiotic therapy, but remain symptomatic.
    Intervention: Procedure: Middle ear fluid and urine.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: August 2, 2012)
0
Original Estimated Enrollment
 (submitted: July 8, 2010)
200
Estimated Study Completion Date June 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age: >= 3 months and < 5 years at the time of enrolment. The subject becomes ineligible on the fifth birthday.
  • Signs, symptoms, and conditions:
  • One of the functional or general signs of otalgia, conjunctivitis, fever AND EITHER
  • Paradise's criteria, OR
  • Spontaneous otorrhoea of less than 1 day.
  • Onset of signs and symptoms of acute otitis media within 3 days prior to diagnosis of acute otitis media by a physician. To be included as treatment failure, subjects must have then received antibiotic treatment from the physician, but remain symptomatic 2-3 days after initiation of treatment.
  • Written informed consent obtained from parent(s) or Legally Acceptable Representative prior to study start.

Exclusion Criteria:

  • Hospitalised during the diagnosis of acute otitis media or during treatment,
  • Otitis externa, or otitis media with effusion,
  • Presence of a transtympanic aerator,
  • Systemic antibiotic treatment received for a disease other than acute otitis media in the 3 days prior to enrolment,
  • Receiving antimicrobial prophylaxis for recurrent acute otitis media,
  • Provision of antibiotic by the ear nose and throat specialist at the enrolment visit, prior to the sampling of the middle ear fluid by tympanocentesis or spontaneous otorrhoea,
  • Patients on antibiotics for acute otitis media who are clinically improving.
  • Child in care.
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Egypt
 
Administrative Information
NCT Number NCT01160055
Other Study ID Numbers 113368
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2015