Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494072
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia a Non-inferiority Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this open label randomized non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course usually 7-14 days of antibiotics in hospitalized children aged 3 months to 18 years with uncomplicated community acquired pneumonia
The main questions it aims to answer are
Does a 5 day course work as well as standard longer courses of antibiotics for treating community acquired pneumonia in children
Does a 5 day course cause less antibiotic side effects compared to a standard longer course of antibiotics in children with community acquired pneumonia
Participants will
be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
receive a brief follow up questionnaire regarding clinical symptoms follow up careantibiotics and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group receiving 5 days duration with the control group standard duration to see if 5 days is as successful as a standard duration
The main questions it aims to answer are
Does a 5 day course work as well as standard longer courses of antibiotics for treating community acquired pneumonia in children
Does a 5 day course cause less antibiotic side effects compared to a standard longer course of antibiotics in children with community acquired pneumonia
Participants will
be randomly assigned to either receive 5 total days or a total duration decided by the treating physician
receive a brief follow up questionnaire regarding clinical symptoms follow up careantibiotics and side effects via phone or email at days 5 and 14 from the start of antibiotics
Researchers will compare the experimental group receiving 5 days duration with the control group standard duration to see if 5 days is as successful as a standard duration
Detailed Description:
This is an open label randomized non-inferiority clinical trial to determine if a 5-day antibiotic course works as well compared to a standard antibiotic course usually 7-10 days of antibiotics in hospitalized children who are aged 3 months to less than 18 years old with uncomplicated community acquired pneumonia
We will recruit 150 participants meeting inclusionexclusion criteria Participants will be randomized to one of the study groups In the experimental group the participant will receive a total antibiotic course of 5 days In the other group control group participants will receive the standard-of-care antibiotic course the duration will be decided by the primary treating physician in this group The selection of antibiotic therapy will be made by the treating physician generally in accordance with the institutional clinical practice guideline on community acquired pneumonia prior to enrollment in the study Other medical care aside from the treatment duration will be the same and will be guided by the primary treating doctor The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital
During the consenting process a member of the research team will verify the contact numbers or email of the parentsguardian of participant to be used after discharge for follow-up communication Every participants parentguardian will receive a text messageemail questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement side effects to the antibiotics recurrence of fever or need for additional antibiotics or other medical care Participants parentsguardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern
The primary objective of this study is to compare the failure rate between a short course 5-days and standard antibiotic course usually 7-10 days of antibiotics of antibiotics in hospitalized children with uncomplicated pneumonia Failure will be defined as the clinical need for additional antibiotic treatment emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation
The secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP Adverse drug events include any allergic reaction such as skin rash itching or other andor abdominal symptoms such as vomiting stomach pain and diarrhea
Data will be summarized by n or mean and standard deviation SD or median and interquartile range IQR Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fishers exact test A 95 CI will be calculated for the difference in failure rate between the shorter antibiotic course 5-day group and the standard course group Non-inferiority will be declared if the 95 CI lies below 10 P005 will be considered statistically significant Data will be analyzed by SAS version 94 SAS Institute Inc Cary NC and SPSS version 280 IBM Corp Armonk NY
We will recruit 150 participants meeting inclusionexclusion criteria Participants will be randomized to one of the study groups In the experimental group the participant will receive a total antibiotic course of 5 days In the other group control group participants will receive the standard-of-care antibiotic course the duration will be decided by the primary treating physician in this group The selection of antibiotic therapy will be made by the treating physician generally in accordance with the institutional clinical practice guideline on community acquired pneumonia prior to enrollment in the study Other medical care aside from the treatment duration will be the same and will be guided by the primary treating doctor The primary treating doctor will also decide when the participant is medically ready for discharge from the hospital
During the consenting process a member of the research team will verify the contact numbers or email of the parentsguardian of participant to be used after discharge for follow-up communication Every participants parentguardian will receive a text messageemail questionnaire on day 5 and day 14 after the start of antibiotics to assess for clinical improvement side effects to the antibiotics recurrence of fever or need for additional antibiotics or other medical care Participants parentsguardian will be contacted by phone for additional information if there is concern for a failure or significant medical concern
The primary objective of this study is to compare the failure rate between a short course 5-days and standard antibiotic course usually 7-10 days of antibiotics of antibiotics in hospitalized children with uncomplicated pneumonia Failure will be defined as the clinical need for additional antibiotic treatment emergency department visit or readmission to the hospital for a suspected lower respiratory tract infection within 14 days of treatment initiation
The secondary objective will compare the rate of adverse drug events between short and long-course durations of antibiotic therapy in children hospitalized for CAP Adverse drug events include any allergic reaction such as skin rash itching or other andor abdominal symptoms such as vomiting stomach pain and diarrhea
Data will be summarized by n or mean and standard deviation SD or median and interquartile range IQR Continuous variables will be compared by t-test while categorical variables will be compared by Chi-square or Fishers exact test A 95 CI will be calculated for the difference in failure rate between the shorter antibiotic course 5-day group and the standard course group Non-inferiority will be declared if the 95 CI lies below 10 P005 will be considered statistically significant Data will be analyzed by SAS version 94 SAS Institute Inc Cary NC and SPSS version 280 IBM Corp Armonk NY
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