Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT03031210
Recruitment Status : Recruiting
First Posted : January 25, 2017
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jocelyn Gravel, St. Justine's Hospital

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).

Condition or disease Intervention/treatment Phase
Community-acquired Pneumonia Drug: Amoxicillin Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Non-severe Community Acquired Pneumonia With Twice Daily Compared to Thrice Daily Regimen- A Non-inferiority Pragmatic Randomized-controlled Trial.
Actual Study Start Date : June 11, 2017
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Twice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in two doses daily.
Drug: Amoxicillin
(90 mg/kg/day) twice daily
Other Name: Amoxil

Active Comparator: Thrice a day regimen
Patients will received a prescription of amoxicillin (90mg/kg/day) divided in three doses daily.
Drug: Amoxicillin
(90 mg/kg/day) twice daily
Other Name: Amoxil




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Emergency department revisit within 72 hours [ Time Frame: 72 hours ]
    Return to the emergency department in the following 72 hours

  2. Second course of antibiotic [ Time Frame: 1 month ]
    Necessity of second course of antibiotics

  3. Clinical recurrence [ Time Frame: 1 month ]
    Another diagnosis of pneumonia

  4. Adverse events [ Time Frame: 10 days ]
    Any adverse event

  5. 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

  6. 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



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.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

    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

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): NCT03031210


Contacts
Layout table for location contacts
Contact: Jocelyn Gravel, MD 514-345-4931 ext 2559 graveljocelyn@hotmail.com
Contact: Ariane Boutin, MD 514-345-4931 arianeboutin@gmail.com

Locations
Layout table for location information
Canada, Quebec
CHU Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T1C5
Contact: Jocelyn Gravel, MD    514-345-4931 ext 2559    graveljocelyn@hotmail.com   
Contact: Ariane Boutin, MD    514-345-4931    arianeboutin@gmail.com   
Principal Investigator: Jocelyn Gravel, MD         
Principal Investigator: Boutin Ariane, MD         
Sub-Investigator: Benoit Carriere, MD         
Sub-Investigator: Marc Lebel, MD         
Sub-Investigator: Michel Roy, MD         
Sponsors and Collaborators
St. Justine's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Jocelyn Gravel, MD Sainte-Justine Hospital

Layout table for additonal information
Responsible Party: Jocelyn Gravel, Principal investigator, St. Justine's Hospital
ClinicalTrials.gov Identifier: NCT03031210     History of Changes
Other Study ID Numbers: BID pneumonia
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Jocelyn Gravel, St. Justine's Hospital:
Non-severe community-acquired pneumonia
Amoxicillin treatment
Twice daily antibiotic regimen
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents