Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04963764
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2021-06-16
Brief Title:
Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia
Status:
COMPLETED
Status Verified Date:
2022-10
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:
PRAPP
Brief Summary:
This pilot study will evaluate study processes and feasibility of a future large-scale clinical trial that proposes to test whether low-risk children managed as outpatients with community-acquired pneumonia CAP and procalcitonin PCT levels 025 ngmL treated with placebo have a similar clinical response to those treated with antibiotics and fewer adverse effects
Detailed Description:
This pilot clinical trial is a 3-site randomized placebo-controlled double-blinded trial assessing the feasibility of comparing amoxicillin to placebo in children 12 months to 6 years of age who present to the ED with Community Acquired Pneumonia CAP a procalcitonin PCT concentration of 025 ngmL and who will be treated as outpatients
Screening and Enrollment This pilot feasibility trial will enroll over a 6-month period and take place at three sites Ann and Robert H Lurie Childrens Hospital of Chicago Cincinnati Childrens Hospital Medical Center and The Childrens Hospital of Philadelphia that are or were members of the Pediatric Emergency Care Applied Research Network PECARN This study aims to enroll 36 patients in total 2 patients per month per site Clinical research coordinators CRCs at participating EDs will screen potentially eligible patients with respiratory tract symptoms and discuss eligibility with the treating attending physician If thought to be eligible and a diagnosis of CAP is presumed by the treating physician the CRC will approach the patient to complete screening procedures The study will proceed in 2 stages each with its own informed consent process During Stage 1 baseline characteristics and serum PCT levels will be ascertained Stage 2 will consist of a randomized trial of amoxicillin vs placebo in the subset of patients from Stage 1 that have PCT 025 ngmL
Randomization After enrollment and confirmation of a PCT 025 ngmL patients will be randomized to a 10-day course of either amoxicillin 80-100 mgkg divided BID up to 4000 mgday or placebo Randomization to amoxicillin or placebo will be at a 11 ratio with block sizes of 2 and 4 Patients will be stratified by the clinical site and randomization will be performed through an online system As a double-blind clinical trial the study patients and their parentsguardians investigators and study staff will be blinded to study treatment assignment for the duration of the study
Study Drug Administration Local investigational drug pharmacies will be provided with active study medication ie amoxicillin and matching placebo Site pharmacies at each institution will store study drug and dispense as needed Study medications will both be liquid reconstituted from powder and will resemble each other with regards to appearance favor consistency and packaging Study products will be labeled with numerical codes that will maintain allocation concealment Site investigational pharmacies will be provided with amoxicillin and placebo in addition to the randomization scheme The pharmacy will aliquot amoxicillin and placebo into blinded bottles based on randomization scheme
Follow-up The guardians of participants will be asked to complete a daily symptom diary using an online data collection form in REDCap during the first 7 days after the initial Emergency Department study visit The follow-up will assess patient condition clinical response signs or symptoms of clinical deterioration and other adverse effects The primary outcome will be assessed at day 7 - 2 days using video chat technology that is standard on most smart phones tablets and computers Video follow-up will be performed by site clinician investigators In the rare case that a mobile device or computer with video chat technology is not available to the family the day 7 follow-up will occur by telephone or text through an online system A final follow-up performed by site research staff by telephone call will occur at Day 21 - 2 days to assess overall disease course and secondary outcomes
Data Collection At baseline demographics medical history and history of current illness will be obtained from all participants during stage 1 pre-randomization Vital signs will be obtained and a brief physical examination will be performed After the initial ED visit patients will record symptoms on daily basis for 6 days via an online data collection form Follow-up assessments will be completed via telehealth visit or telephone for days 7 and 21 Follow-up visits will collect data regarding symptoms adverse events and return to medical care in addition to assessing adherence to study procedures ie medication adherence and daily symptom diary completion If there is concern for adverse events or deterioration that may warrant medical care the participants caregiver will be instructed to contact their primary care physician emergency department or call 911 as indicated
Screening and Enrollment This pilot feasibility trial will enroll over a 6-month period and take place at three sites Ann and Robert H Lurie Childrens Hospital of Chicago Cincinnati Childrens Hospital Medical Center and The Childrens Hospital of Philadelphia that are or were members of the Pediatric Emergency Care Applied Research Network PECARN This study aims to enroll 36 patients in total 2 patients per month per site Clinical research coordinators CRCs at participating EDs will screen potentially eligible patients with respiratory tract symptoms and discuss eligibility with the treating attending physician If thought to be eligible and a diagnosis of CAP is presumed by the treating physician the CRC will approach the patient to complete screening procedures The study will proceed in 2 stages each with its own informed consent process During Stage 1 baseline characteristics and serum PCT levels will be ascertained Stage 2 will consist of a randomized trial of amoxicillin vs placebo in the subset of patients from Stage 1 that have PCT 025 ngmL
Randomization After enrollment and confirmation of a PCT 025 ngmL patients will be randomized to a 10-day course of either amoxicillin 80-100 mgkg divided BID up to 4000 mgday or placebo Randomization to amoxicillin or placebo will be at a 11 ratio with block sizes of 2 and 4 Patients will be stratified by the clinical site and randomization will be performed through an online system As a double-blind clinical trial the study patients and their parentsguardians investigators and study staff will be blinded to study treatment assignment for the duration of the study
Study Drug Administration Local investigational drug pharmacies will be provided with active study medication ie amoxicillin and matching placebo Site pharmacies at each institution will store study drug and dispense as needed Study medications will both be liquid reconstituted from powder and will resemble each other with regards to appearance favor consistency and packaging Study products will be labeled with numerical codes that will maintain allocation concealment Site investigational pharmacies will be provided with amoxicillin and placebo in addition to the randomization scheme The pharmacy will aliquot amoxicillin and placebo into blinded bottles based on randomization scheme
Follow-up The guardians of participants will be asked to complete a daily symptom diary using an online data collection form in REDCap during the first 7 days after the initial Emergency Department study visit The follow-up will assess patient condition clinical response signs or symptoms of clinical deterioration and other adverse effects The primary outcome will be assessed at day 7 - 2 days using video chat technology that is standard on most smart phones tablets and computers Video follow-up will be performed by site clinician investigators In the rare case that a mobile device or computer with video chat technology is not available to the family the day 7 follow-up will occur by telephone or text through an online system A final follow-up performed by site research staff by telephone call will occur at Day 21 - 2 days to assess overall disease course and secondary outcomes
Data Collection At baseline demographics medical history and history of current illness will be obtained from all participants during stage 1 pre-randomization Vital signs will be obtained and a brief physical examination will be performed After the initial ED visit patients will record symptoms on daily basis for 6 days via an online data collection form Follow-up assessments will be completed via telehealth visit or telephone for days 7 and 21 Follow-up visits will collect data regarding symptoms adverse events and return to medical care in addition to assessing adherence to study procedures ie medication adherence and daily symptom diary completion If there is concern for adverse events or deterioration that may warrant medical care the participants caregiver will be instructed to contact their primary care physician emergency department or call 911 as indicated
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