Duration of Antimicrobial Therapy for Paediatric Pneumonia

This study has suspended participant recruitment.
(Pilot phase completed.)
Sponsor:
Information provided by (Responsible Party):
Jeffrey Pernica, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier:
NCT01707485
First received: October 12, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

This study will investigate the feasibility of testing whether a 5-day course of antibiotics is as effective as a 10-day course for the treatment of uncomplicated community-acquired pneumonia (CAP) in children. To accomplish this, previously well children aged 1-10 years who present to McMaster Children's Hospital (MCH) emergency department (ED) with CAP will, if they consent, be randomly chosen to be given either a 5 day or 10 day course of amoxicillin. Neither the child, the child's caregiver, nor the researchers will know whether the child is in the 5- or 10-day antibiotic group. Once the child has received the medication and for two weeks after that, caregivers of children will be asked to complete a daily symptom diary for their child, and will come to MCH at the end of the two week period (between day 14-18) to be assessed by one of the researchers. This information will then be used to compare both groups of children to determine if a 5 days of treatment is non-inferior to 10 days. The investigators hypothesize that running such a trial is feasible.


Condition Intervention Phase
Pneumonia
Drug: amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short Course Antimicrobial Therapy for Paediatric Community-Acquired Pneumonia: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Hamilton Health Sciences Corporation:

Primary Outcome Measures:
  • clinical cure [ Time Frame: 14-18 days post-randomization ] [ Designated as safety issue: No ]
    Resolution of symptoms and signs of pneumonia.


Secondary Outcome Measures:
  • absentee days [ Time Frame: 14 d post-randomization ] [ Designated as safety issue: No ]
  • number of days of adverse reactions [ Time Frame: 14 d post randomization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Short course
amoxicillin. high-dose, 5 days
Drug: amoxicillin
dosed 75-100 mg/kg/day (standardized dosing)
Active Comparator: Standard therapy
amoxicillin, high-dose, 10 days
Drug: amoxicillin
dosed 75-100 mg/kg/day (standardized dosing)

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children aged 1-10 y presenting to the emergency department
  • must fulfil definition of 'pneumonia', ie.

    1) any one of:

  • fever in the ED,
  • a recorded fever at home in the 48h prior to presentation, or
  • WBC > 12 or WBC < 5 in the ED;

    2) any one of:

  • tachypnoea on exam;
  • cough on exam or by history;
  • increased work of breathing on exam; or
  • auscultatory findings consistent with pneumonia; 3) a lobar consolidation on chest radiograph as judged by the ED physician; and 4) the attending ED physician diagnoses the child with primary CAP
  • well enough to be discharged home from the emergency

Exclusion Criteria:

  • 2 or more episodes of emesis in the emergency
  • history of CF, anatomic lung disease, bronchiectasis, congenital heart disease, repeated aspirations, malignancy, immune suppression, recent prolonged admission to hospital, pneumonia diagnosed within the last month, lung abscess within the past six months, > 24 hours of beta-lactam antibiotic therapy prior to presentation, allergy to penicillin, allergy to food colouring
  • evidence of empyaema or necrotizing pneumonia on chest radiograph
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707485

Locations
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Jeffrey Pernica, MD Hamilton Health Sciences Corporation
  More Information

No publications provided

Responsible Party: Jeffrey Pernica, Head, Division of Pediatric Infectious Disease, Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT01707485     History of Changes
Other Study ID Numbers: NIF-12303
Study First Received: October 12, 2012
Last Updated: April 1, 2014
Health Authority: Canada: Health Canada

Keywords provided by Hamilton Health Sciences Corporation:
Antibiotics

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014