Short-course Antimicrobial Therapy for Paediatric Respiratory Infections

NCT ID: NCT02380352

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-04-30

Brief Summary

Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.

Conditions

Community-acquired Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Short-course

5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID

Group Type: EXPERIMENTAL

Amoxicillin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.

Standard

5 days amoxicillin 90 mg/kg/day divided TID followed by alternate formulation 5 days amoxicillin 90 mg/kg/day divided TID

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

Interventions

Amoxicillin

Intervention Type: DRUG

Placebo

Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.

Intervention Type: DRUG

Other Intervention Names

Amoxil

Eligibility Criteria

Inclusion Criteria

Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:

1. fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation;

2. any one of:

1. tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age);

2. cough on exam or by history;

3. increased work of breathing on exam; or

4. auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;

3. infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and

Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.

Exclusion Criteria

Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey M Pernica, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

McMaster Children's Hospital

Hamilton, Ontario, Canada

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Countries

Canada

References

Pernica JM, Harman S, Kam AJ, Carciumaru R, Vanniyasingam T, Crawford T, Dalgleish D, Khan S, Slinger RS, Fulford M, Main C, Smieja M, Thabane L, Loeb M. Short-Course Antimicrobial Therapy for Pediatric Community-Acquired Pneumonia: The SAFER Randomized Clinical Trial. JAMA Pediatr. 2021 May 1;175(5):475-482. doi: 10.1001/jamapediatrics.2020.6735.

Reference Type: DERIVED

PMID: 33683325 (View on PubMed)

Pernica J, Harman S, Kam A, Bailey J, Carciumaru R, Khan S, Fulford M, Thabane L, Slinger R, Main C, Smieja M, Loeb M. Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial. Trials. 2018 Feb 1;19(1):83. doi: 10.1186/s13063-018-2457-2.

Reference Type: DERIVED

PMID: 29391051 (View on PubMed)

Other Identifiers

SAFER 001 PSI

Identifier Type: -

Identifier Source: org_study_id

NCT01707485

Identifier Type: -

Identifier Source: nct_alias