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

Infections, Streptococcal Clinical Trial

Official title:

Identification and Characterisation of the Bacteria Causing Acute Otitis Media (AOM) Episodes in Young Children in Egypt

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01160055
• Other study ID #: 113368
• Status: Withdrawn
• Phase: N/A
• First received: July 1, 2010
• Last updated: April 9, 2015
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Streptococcal
• Otitis Media
• Streptococcal Infections

Intervention

Procedure:
• Middle ear fluid and urine.
Middle ear fluid and urine collection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of bacterial pathogens isolated from middle ear fluid samples.		12 Months	No
Secondary	Occurrence of bacterial serotypes.		12 Months	No
Secondary	Antimicrobial susceptibility of bacteria isolated from middle ear fluid samples, as assessed by standard microbiological techniques.		12 Months	No
Secondary	Occurrence of treatment failure of acute otitis media and of recurrent acute otitis media.		12 Months	No
Secondary	Occurrence of spontaneous otorrhoea.		12 Months	No
Secondary	Occurrence of bacteria in acute otitis media cases with treatment failure and in new Acute Otitis Media cases without treatment therapy.		12 Months	No
Secondary	Occurrence of bacteria in acute otitis media cases vaccinated with a pneumococcal vaccine.		12 Months	No