Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children
Brief Summary: This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.


Options:
A: Inclusion Criteria:

* aged 6 to 23 months
* have received at least two doses of pneumococcal conjugate vaccine (Prevnar) and Haemophilus influenzae type B vaccine
* have evidence of acute otitis media (AOM) defined as:

  1. Recent (within 48 hours), onset of signs and symptoms and a score of greater than or equal to 3 on the AOM-SOS scale.
  2. Middle ear effusion evidenced by at least two of the following:
* decreased or absent tympanic membrane mobility by pneumatic otoscopy,
* yellow or white discoloration of the tympanic membrane,
* opacification of the tympanic membrane, plus
* 1+ bulging of the tympanic membrane with either marked erythema or otalgia, or
* 2+ or 3+ bulging of the tympanic membrane

Exclusion Criteria:

* certain signs or symptoms (e.g., toxic appearance \[capillary refill greater than 3 seconds, systolic blood pressure less than 60 mm Hg\], otalgia for a period greater than 48 hours, spontaneous perforation of the tympanic membrane and drainage or temperature greater than or equal to 105 degrees F);
* clinical or anatomical characteristics that might obscure response to treatment (e.g., tympanostomy tube\[s\] in place or a history of tympanostomy tubes, unrepaired or repaired overt or submucous cleft palate, high-arched palate, or Down's syndrome);
* underlying systemic problems that might obscure response to infection (e.g., serious underlying disease \[e.g., cystic fibrosis, neoplasm, juvenile diabetes\]), concomitant infection that would preclude evaluation of the response of the child's AOM to study medication, known renal insufficiency (i.e., serum creatinine greater than or equal to 1.5 times upper limit of normal for age), known hepatic insufficiency or a history of amoxicillin-clavulanate-associated cholestatic jaundice or hepatic dysfunction, history of immune dysfunction, deficiency or receipt of immunosuppressive therapy, chronic gastrointestinal conditions (i.e., malabsorption, inflammatory bowel disease), malignancy;
* sensorineural hearing loss either unilateral or bilateral;
* comedications (e.g., systemic corticosteroids at any point while enrolled in the study, more than one dose of systemic antimicrobial therapy within 96, any investigational drug or vaccine;
* hypersensitivity to penicillin, amoxicillin or amoxicillin-clavulanate, or phenylketonuria or known hypersensitivity to aspartame;
* unable to complete the study protocol or not having access to a telephone; and
* current enrollment in another study or previously enrolled in this study.
B: Inclusion Criteria:

* Children with acute otitis media

Exclusion Criteria:

* Amoxicillin allergy
* Tympanic membrane perforation
* Tympanostomy tubes (current)
* Complication of acute otitis media such as mastoiditis
C: Inclusion Criteria:

* Children between the ages of 6 months - 12 years who were diagnosed with Acute Otitis Media

Exclusion Criteria:

* 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
* 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
D: Inclusion Criteria:

* Acute otitis media
* Age 6 - 35 mo

Exclusion Criteria:

* Spontaneous perforation of the tympanic membrane and drainage
* Systemic or nasal corticosteroid therapy within 3 preceding days
* Antihistamine therapy with 3 preceding days
* Oseltamivir therapy within 3 preceding days
* Allergy to amoxicillin/penicillin
* Tympanostomy tube present in tympanic membrane
* Clinical evidence of infection requiring systemic antimicrobial treatment
* Documented Ebstein Barr virus infection within 7 preceding days
* Down syndrome or other condition to affect middle ear infections
* Known immunodeficiency
* Vomiting or another symptom to violate per oral dosage
* Poor parental co-operation due to language or other reasons
* Use of any investigational drugs during the 4 preceding weeks

Answer: D