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Trial record 1 of 1 for:    NCT02891915
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Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children

This study is currently recruiting participants.
Verified April 5, 2017 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02891915
First Posted: September 8, 2016
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
  Purpose
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)

Condition Intervention Phase
Pneumonia Drug: Amoxicillin Drug: Amoxicillin-clavulanate Drug: Cefdinir Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IV Double-Blind, Placebo-Controlled, Randomized Trial to Evaluate Short Course vs.Standard Course Outpatient Therapy of Community Acquired Pneumonia in Children (SCOUT-CAP)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Desirability of Outcome Ranking (DOOR) [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days) ]

Secondary Outcome Measures:
  • Adequate clinical response rates (a component of DOOR) [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days), Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]
  • Desirability of Outcome Ranking (DOOR) [ Time Frame: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]
  • Frequency of solicited events [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days), Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]
  • Receipt of non-study systemic antibiotics for all causes during medically attended visits [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days), Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]
  • Receipt of non-study systemic antibiotics for persistent or worsening pneumonia during medically attended visits [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days), Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]
  • Resolution of symptoms (a component of DOOR) [ Time Frame: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days), Outcome Assessment Visit 2 (Study Day 22 +/- 3 days) ]

Estimated Enrollment: 400
Actual Study Start Date: October 4, 2016
Estimated Study Completion Date: March 1, 2019
Estimated Primary Completion Date: January 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Short
200 subjects will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Drug: Amoxicillin
Amoxicillin is an aminopenicillin antibiotic
Drug: Amoxicillin-clavulanate
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.
Drug: Cefdinir
Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Other: Placebo
Placebo
Active Comparator: Standard
200 subjects will receive a standard course of the initially prescribed antibiotic( Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Drug: Amoxicillin
Amoxicillin is an aminopenicillin antibiotic
Drug: Amoxicillin-clavulanate
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.
Drug: Cefdinir
Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 6 - 71 months
  2. Provider diagnosis of CAP and prescription of antibiotic therapy with amoxicillin, amoxicillin-clavulanate, or cefdinir

    - amoxicillin or amoxicillin-clavulanate prescribed at a amoxicillin dose of 60 mg/kg/day

    -- cefdinir prescribed at a minimum dose of 10 mg/kg/day

  3. Parental report of clinical improvement

    - based on lack of either subjective or known fever temperature >/= 38.3°C in the preceding 24 hours; current respiratory rate no greater than 50 breaths/minute (<2 years of age) or breaths/minute (= / > 2 years of age); and current grade of cough < 3

  4. Ability of a parent or guardian to understand and comply with the study procedures and be available for all study visits
  5. Signed written informed consent by a parent or guardian

Exclusion Criteria:

1. Treatment with any systemic antibiotic therapy within 7 days before the diagnosis of CAP 2. Initial therapy for CAP with combination antibiotic therapy

  • amoxicillin, amoxicillin/clavulanate or cefdinir plus one or more additional oral, intravenous, or intramuscular antibiotics 3. History of anaphylaxis or severe drug allergy to amoxicillin, if prescribed amoxicillin or amoxicillin/clavulanic acid; or oral cephalosporin antibiotics (except cefaclor), if prescribed cefdinir 4. Presence of concomitant bacterial infection that requires > 5 days of antibiotic therapy 5. Radiographic findings (where applicable) of complicated pneumonia at presentation or any subsequent chest radiograph up to the time of enrollment
  • clinically significant pleural effusion, lung abscess, or pneumatocele 6. Hospitalization for pneumonia during Day -5 to -1 of antibiotic therapy for CAP
  • subjects who require serial clinical assessments, but are discharged within 24 hours will not be considered hospitalized and will not satisfy this exclusion criterion 7. Pneumonia due to S. aureus or group A streptococcus documented by positive blood culture or PCR, at the time of enrollment 8. History of pneumonia within the previous 6 months 9. History of persistent asthma within the previous 6 months or current acute asthma exacerbation
  • persistent asthma is defined as receiving daily asthma maintenance therapy such as inhaled corticosteroids, cromolyn, theophylline, or leukotriene receptor antagonists

    -- acute asthma exacerbation is defined as receiving concomitant bronchodilator therapy and systemic corticosteroids 10. Provider-diagnosis of aspiration pneumonia, bronchiolitis, or bronchitis 11. Surgery or other invasive procedures of the upper or lower airway (e.g., bronchoscopy, laryngoscopy) with general anesthesia or hospitalization </=7 days before diagnosis of CAP 12. History of an underlying chronic medical condition

  • including chronic heart disease, chronic lung disease (except asthma), congenital anomalies of the airways or lung, cystic fibrosis, chronic renal disease including nephrotic syndrome, protein-losing enteropathy of any cause, severe malnutrition, genetic syndromes, neurocognitive disorders, or metabolic disorders (including phenylketonuria) 13. History of a condition that compromises the immune system
  • HIV infection, primary immunodeficiency, anatomic or functional asplenia; receipt of a hematopoietic stem cell or solid organ transplant at any time; receipt of immunosuppressive therapy including chemotherapeutic agents, biologic agents, antimetabolites or radiation therapy during the past 12 months; or daily use of systemic corticosteroids for more than 7 consecutive days during the past 14 days 14. Any other condition that in the judgment of the investigator precludes participation because it could affect the safety of the subject 15. Current enrollment in another clinical trial of an investigational agent 16. Previous enrollment in this trial
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891915


Contacts
Contact: Clarence Buddy Creech 16159362186 buddy.creech@vanderbilt.edu

Locations
United States, Alabama
University of Alabama - Children's of Alabama - Infectious Diseases/Virology Not yet recruiting
Birmingham, Alabama, United States, 35233-1711
United States, Arkansas
Arkansas Children's Hospital - Infectious Diseases Not yet recruiting
Little Rock, Arkansas, United States, 72202-3500
United States, Kentucky
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases Not yet recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
Washington University School of Medicine in St. Louis - Infectious Diseases Not yet recruiting
Saint Louis, Missouri, United States, 63110-1010
United States, North Carolina
Duke Human Vaccine Institute - Duke Clinical Vaccine Unit Recruiting
Durham, North Carolina, United States, 27704
United States, Ohio
Cincinnati Children's Hospital Medical Center - Infectious Diseases Completed
Cincinnati, Ohio, United States, 45229-3039
United States, Pennsylvania
Children's Hospital of Philadelphia - The Center for Pediatric Clinical Effectiveness Recruiting
Philadelphia, Pennsylvania, United States, 19104-3309
Children's Hospital of Pittsburgh of UPMC - General Academic Pediatric Recruiting
Pittsburgh, Pennsylvania, United States, 15213-3205
United States, Tennessee
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center Recruiting
Nashville, Tennessee, United States, 37232-2573
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02891915     History of Changes
Other Study ID Numbers: 14-0079
HHSN272201300023I
First Submitted: September 1, 2016
First Posted: September 8, 2016
Last Update Posted: October 27, 2017
Last Verified: April 5, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Antimicrobial
Beta-Lactam
Pneumonia
Short Course
Standard Course
Therapy

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
beta-Lactams
Cefdinir
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action