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Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.

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ClinicalTrials.gov Identifier: NCT03031210
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date October 20, 2020
Actual Study Start Date  ICMJE June 11, 2017
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Clinical failure within 10 days of enrolment [ Time Frame: Day 10 (after enrolment) ]
As a primary outcome, clinical failure will be defined by any of the following occurring within 10 days of enrolment:
  • Death or hospitalisation
  • A need for a change in antibiotic according to the treating physician. In our settings, common reasons to change antibiotic are:
    • Persistence of fever at 72h
    • Clinical deterioration: • Clinical deterioration will include the development of lower chest-wall indrawing, central cyanosis, stridor while calm, or danger signs as defined by: inability to drink or breastfeed, convulsions, persistent vomiting, lethargy, or unconsciousness at any time during a child's treatment.
    • Development of a comorbid condition such as a meningitis, bacteriemia, osteomyelitis or septic arthritis
    • Allergic reaction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Emergency department revisit within 72 hours [ Time Frame: 72 hours ]
    Return to the emergency department in the following 72 hours
  • Second course of antibiotic [ Time Frame: 1 month ]
    Necessity of second course of antibiotics
  • Clinical recurrence [ Time Frame: 1 month ]
    Another diagnosis of pneumonia
  • Adverse events [ Time Frame: 10 days ]
    Any adverse event
  • Number of working days missed by caregivers or school/daycare days missed by patients [ Time Frame: 1 month ]
    Total number of days missed by caregivers or school/daycare days missed by the parents
  • Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration [ Time Frame: 10 days ]
    Measured on a likert scale through a telephone survey
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • ED revisit within 72 hours [ Time Frame: 72 hours ]
  • Second course of antibiotic [ Time Frame: 1 month ]
  • Clinical recurrence [ Time Frame: 1 month ]
  • Adverse events [ Time Frame: 10 days ]
  • Number of working days missed by caregivers or school/daycare days missed by patients [ Time Frame: 1 month ]
  • Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration [ Time Frame: 10 days ]
    Measured on a likert scale through a telephone survey
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
Official Title  ICMJE Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
Brief Summary The aim of this study will be to evaluate whether a twice-daily antibiotic regimen is non-inferior to a thrice-daily regimen for the treatment of non-severe community acquired pneumonia in children presenting at a paediatric Emergency Department (ED).
Detailed Description A single-center, non-blinded, pragmatic, randomized-controlled, non-inferiority clinical trial will be conducted in an urban, university-affiliated, tertiary care pediatric hospital ED. All patients three months old to 18 years of age who had symptoms and signs suggestive of non-severe community acquired pneumonia based on respiratory complaints and a pulmonary infiltrate identified by trained paediatricians or emergency physicians will be eligible to the present study. Study participants will be randomly allocated to receive either amoxicillin (90mg/kg per day) in twice or thrice daily regimen. Primary outcome will be treatment failure within 10 days of enrolment as defined by hospitalisation, need for a change in antibiotic (persistence of fever at 72 hours, clinical deterioration, comorbid condition or development of serious adverse reactions) and death. ED revisits within 72 hours, second course of antibiotic and clinical recurrence rates will be evaluated in the follow-up assessments as well as percent of adverse events encountered, number of days missed (work, school or daycare), coverage vaccination rate, protocol adherence and patient and parental satisfaction. The primary analysis will use an intention-to-treat approach. Per-protocol analysis will also be carried to compare the failure rate. Accounting to a maximal 10% drop-off rate, a sample size of 685 participants per arm was calculated to have a power of 90% to identify a difference of ≤ 5% with an alpha value of 0.05.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Community-acquired Pneumonia
Intervention  ICMJE Drug: Amoxicillin
(90 mg/kg/day) twice daily
Other Name: Amoxil
Study Arms  ICMJE
  • Experimental: Twice a day regimen
    Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
    Intervention: Drug: Amoxicillin
  • Active Comparator: Thrice a day regimen
    Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
    Intervention: Drug: Amoxicillin
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  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
1370
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date June 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients 3 months to 18 years of age attending the pediatric ED and diagnosed with a non-severe pneumonia, will be considered for enrolment. More precisely, the following inclusion criteria will be required:

    1. Presence of respiratory symptoms (cough and/or dyspnea)
    2. Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles)
    3. Presence of fever
    4. Positive chest radiography as interpreted by the treating physician

Exclusion Criteria:

  • Any danger signs associated with pneumonia (severe indrawing, shock or severe dehydration, empyema, important pleural effusion, pulmonary abcess or pneumatocoele)
  • History of anaphylactic or allergic reaction to penicillin or amoxicillin according to the treating physician.
  • History of a serious nonimmunoglobulin E-mediated reactions (eg, Stevens-Johnson syndrome or toxic epidermal necrolysis) attributed to amoxicilin.
  • Caregiver unable to provide consent (language barrier or lack of caregiver presence)
  • Underlying unstable chronic illness (ie. cystic fibrosis, immune suppression, active tuberculosis, bronchiectasis or active pulmonary malignancies)
  • Persistent/chronic pneumonia syndromes (with symptoms for >2 weeks), suspected by the physician to be caused by atypical pathogens, hospital- acquired pneumonia (been hospitalized within 2 weeks prior to enrolment), aspiration pneumonia or recurrent pneumonias.
  • Any history of receiving amoxicillin within the past month
  • Need hospitalisation for any other reasons (ie. persistent vomiting, severe life-threatening infection such as septicaemia or meningitis requiring intravenous antimicrobial agents)
  • Previous participation in study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jocelyn Gravel, MD 514-345-4931 ext 2559 graveljocelyn@hotmail.com
Contact: Ariane Boutin, MD 514-345-4931 arianeboutin@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03031210
Other Study ID Numbers  ICMJE BID pneumonia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jocelyn Gravel, St. Justine's Hospital
Study Sponsor  ICMJE St. Justine's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jocelyn Gravel, MD Sainte-Justine Hospital
PRS Account St. Justine's Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP