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

Primary Purpose

Community-acquired Pneumonia

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Amoxicillin
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-acquired Pneumonia focused on measuring Non-severe community-acquired pneumonia, Amoxicillin treatment, Twice daily antibiotic regimen

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Sainte-JustineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Twice a day regimen

Thrice a day regimen

Arm Description

Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.

Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.

Outcomes

Primary Outcome Measures

Clinical failure within 10 days of 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

Secondary Outcome Measures

Emergency department revisit within 72 hours
Return to the emergency department in the following 72 hours
Second course of antibiotic
Necessity of second course of antibiotics
Clinical recurrence
Another diagnosis of pneumonia
Adverse events
Any adverse event
Number of working days missed by caregivers or school/daycare days missed by patients
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
Measured on a likert scale through a telephone survey

Full Information

First Posted
January 23, 2017
Last Updated
May 3, 2022
Sponsor
St. Justine's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03031210
Brief Title
Twice Daily Treatment With Amoxicillin for Non-severe Community Acquired Pneumonia.
Official Title
Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 11, 2017 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community-acquired Pneumonia
Keywords
Non-severe community-acquired pneumonia, Amoxicillin treatment, Twice daily antibiotic regimen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Twice a day regimen
Arm Type
Experimental
Arm Description
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
Arm Title
Thrice a day regimen
Arm Type
Active Comparator
Arm Description
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Amoxil
Intervention Description
(90 mg/kg/day) twice daily
Primary Outcome Measure Information:
Title
Clinical failure within 10 days of enrolment
Description
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
Time Frame
Day 10 (after enrolment)
Secondary Outcome Measure Information:
Title
Emergency department revisit within 72 hours
Description
Return to the emergency department in the following 72 hours
Time Frame
72 hours
Title
Second course of antibiotic
Description
Necessity of second course of antibiotics
Time Frame
1 month
Title
Clinical recurrence
Description
Another diagnosis of pneumonia
Time Frame
1 month
Title
Adverse events
Description
Any adverse event
Time Frame
10 days
Title
Number of working days missed by caregivers or school/daycare days missed by patients
Description
Total number of days missed by caregivers or school/daycare days missed by the parents
Time Frame
1 month
Title
Patient's and parents satisfaction with the discharge instructions' provided and the ease of administration
Description
Measured on a likert scale through a telephone survey
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: Presence of respiratory symptoms (cough and/or dyspnea) Presence of signs of pneumonia (tachypnea, abnormal breath sounds, crackles) Presence of fever 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Gravel, MD
Phone
514-345-4931
Ext
2559
Email
graveljocelyn@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ariane Boutin, MD
Phone
514-345-4931
Email
arianeboutin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD
Organizational Affiliation
Sainte-Justine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD
Phone
514-345-4931
Ext
2559
Email
graveljocelyn@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ariane Boutin, MD
Phone
514-345-4931
Email
arianeboutin@gmail.com
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD
First Name & Middle Initial & Last Name & Degree
Boutin Ariane, MD
First Name & Middle Initial & Last Name & Degree
Benoit Carriere, MD
First Name & Middle Initial & Last Name & Degree
Marc Lebel, MD
First Name & Middle Initial & Last Name & Degree
Michel Roy, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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