Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical
      trial will test the effectiveness of short (5-day) vs.standard (10-day) course therapy in
      children who are diagnosed with CAP and initially treated in outpatient clinics, urgent care
      facilities, and emergency departments. Primary objective is to compare the composite overall
      outcome (Desirability of Outcome Ranking, DOOR) among children 6-71 months of age with CAP
      assigned to a strategy of short course (5 days) vs standard course (10 days) outpatient
      beta-lactam therapy at Outcome Assessment Visit #1 (Study Day 8 +/- 2 days)
    

Detailed description: 
      This is a multi-center, randomized, double-blind, placebo-controlled, superiority clinical
      trial evaluating short course (5 day) vs. standard course (10 day) of oral beta-lactam
      antibiotic therapy (amoxicillin, amoxicillin-clavulanate, cefdinir) for treatment of CAP in
      children 6-71 months of age who have clinically improved prior to enrollment. The study will
      randomize approximately 400 enrolled subjects to one of the two study arms (approximately 200
      children in each arm) in order to reach 360 subjects completing Outcome Assessment Visit 1.
      Subjects will be randomized (1:1) to receive either a standard course of the initially
      prescribed antibiotic (10 days) or a short course of the initially prescribed antibiotic (5
      days) plus 5 days of matching placebo. The study will recruit potential subjects from
      children who are diagnosed with CAP and who are initiated on oral beta-lactam therapy by
      healthcare providers in EDs, outpatient clinics, and urgent care centers at the study sites.
      Day -5 is defined as the date on which oral beta-lactam therapy is initiated for a diagnosis
      of CAP. Potential subjects will be identified at any time following clinical diagnosis of
      pneumonia. These subjects will be assessed for eligibility and enrolled on Day -3 to -1 of
      their initially prescribed oral beta-lactam therapy. Subjects may also be enrolled on Day 1
      (the first day of receipt of study agent) provided they have not yet received any doses of
      the healthcare provider-prescribed antibiotic therapy for that day. The Primary objective is
      to compare the composite overall outcome (Desirability of Outcome Ranking, DOOR) among
      children 6-71 months of age with CAP assigned to a strategy of short course (5 days) vs
      standard course (10 days) outpatient beta-lactam therapy at Outcome Assessment Visit #1
      (Study Day 8 +/- 2 days). The Secondary objectives are: 1) To compare the composite overall
      outcome (DOOR) among children 6-71 months of age with CAP assigned to a strategy of short
      course (5 days) vs standard course (10 days) outpatient beta-lactam therapy at Outcome
      Assessment Visit #2 (Study Day 22 +/- 3 days); 2) To compare the resolution of symptoms (a
      component of DOOR) among children 6-71 months of age with CAP assigned to a strategy of short
      course (5 days) vs standard course (10 days) outpatient beta-lactam therapy at Outcome
      Assessment Visits #1 and #2; 3) To compare the clinical response (a component of DOOR) among
      children 6-71 months of age with CAP assigned to a strategy of short course (5 days) vs
      standard course (10 days) outpatient beta-lactam therapy at Outcome Assessment Visits #1 and
      #2; 4) To compare solicited events (a component of DOOR) among children 6-71 months of age
      with CAP assigned to a strategy of short course (5 days) vs standard course (10 days)
      outpatient beta-lactam therapy at Outcome Assessment Visits #1 and #2; 5) To compare
      medically attended visits to Emergency Departments (ED) or outpatient clinics,
      hospitalizations, surgical procedures, and receipt of non-study systemic antibiotics
      (components of the clinical response) among children 6-71 months of age with CAP assigned to
      a strategy of short course (5 days) vs standard course (10 days) outpatient beta-lactam
      therapy at Outcome Assessment Visits #1 and #2
    

Intervention name(s): Amoxicillin; Amoxicillin-clavulanate; Cefdinir; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Amoxicillin is an aminopenicillin antibiotic; A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.; Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.; Placebo
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Cefdinir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Antimicrobial; Beta-Lactam; Pneumonia; Short Course; Standard Course; Therapy