Ignite Creation Date:
2024-05-06 @ 9:03 AM
Last Modification Date:
2024-10-26 @ 12:09 PM
Study NCT ID:
NCT02891915
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2016-09-01
Brief Title:
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase IV Double-Blind Placebo-Controlled Randomized Trial to Evaluate Short Course vsStandard Course Outpatient Therapy of Community Acquired Pneumonia in Children SCOUT-CAP
Status:
COMPLETED
Status Verified Date:
2017-04-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center randomized double-blind placebo-controlled superiority clinical trial will test the effectiveness of short 5-day vsstandard 10-day course therapy in children who are diagnosed with CAP and initially treated in outpatient clinics urgent care facilities and emergency departments Primary objective is to compare the composite overall outcome Desirability of Outcome Ranking DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visit 1 Study Day 8 - 2 days
Detailed Description:
This is a multi-center randomized double-blind placebo-controlled superiority clinical trial evaluating short course 5 day vs standard course 10 day of oral beta-lactam antibiotic therapy amoxicillin amoxicillin-clavulanate cefdinir for treatment of CAP in children 6-71 months of age who have clinically improved prior to enrollment The study will randomize approximately 400 enrolled subjects to one of the two study arms approximately 200 children in each arm in order to reach 360 subjects completing Outcome Assessment Visit 1 Subjects will be randomized 11 to receive either a standard course of the initially prescribed antibiotic 10 days or a short course of the initially prescribed antibiotic 5 days plus 5 days of matching placebo The study will recruit potential subjects from children who are diagnosed with CAP and who are initiated on oral beta-lactam therapy by healthcare providers in EDs outpatient clinics and urgent care centers at the study sites Day -5 is defined as the date on which oral beta-lactam therapy is initiated for a diagnosis of CAP Potential subjects will be identified at any time following clinical diagnosis of pneumonia These subjects will be assessed for eligibility and enrolled on Day -3 to -1 of their initially prescribed oral beta-lactam therapy Subjects may also be enrolled on Day 1 the first day of receipt of study agent provided they have not yet received any doses of the healthcare provider-prescribed antibiotic therapy for that day The Primary objective is to compare the composite overall outcome Desirability of Outcome Ranking DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visit 1 Study Day 8 - 2 days The Secondary objectives are 1 To compare the composite overall outcome DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visit 2 Study Day 22 - 3 days 2 To compare the resolution of symptoms a component of DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visits 1 and 2 3 To compare the clinical response a component of DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visits 1 and 2 4 To compare solicited events a component of DOOR among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visits 1 and 2 5 To compare medically attended visits to Emergency Departments ED or outpatient clinics hospitalizations surgical procedures and receipt of non-study systemic antibiotics components of the clinical response among children 6-71 months of age with CAP assigned to a strategy of short course 5 days vs standard course 10 days outpatient beta-lactam therapy at Outcome Assessment Visits 1 and 2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN272201300023I | None | None | None |