Trial Outcomes & Findings for Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children (NCT NCT02891915)
NCT ID: NCT02891915
Last Updated: 2021-02-03
Results Overview
DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
385 participants
Primary outcome timeframe
Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)
Results posted on
2021-02-03
Participant Flow
Children, males and females, aged 6-71 months who are diagnosed with Community Acquired Pneumonia (CAP) and initially treated in outpatient clinics, urgent care facilities, and emergency departments were enrolled. Participants were enrolled between 02DEC2016 and 22NOV2019.
Participant milestones
| Measure |
Short Course
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
193
|
|
Overall Study
COMPLETED
|
179
|
181
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
Short Course
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Overall Study
Enrolled but Treatment Not Administered
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Became Ineligible After Enrollment
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
Baseline characteristics by cohort
| Measure |
Short Course
n=192 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=193 Participants
Participants will receive a standard course of the initially prescribed antibiotic( Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
Total
n=385 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.6 months
STANDARD_DEVIATION 16.6 • n=5 Participants
|
36.8 months
STANDARD_DEVIATION 17.8 • n=7 Participants
|
35.7 months
STANDARD_DEVIATION 17.2 • n=5 Participants
|
|
Age, Customized
< 24 Months
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Age, Customized
24-71 Months
|
137 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
176 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
349 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
121 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 participants
n=5 Participants
|
193 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
Region of Enrollment
United States · Arkansas Children's Hospital
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Children's Hospital of Philadelphia
|
59 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Children's Hospital of Pittsburgh
|
67 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Cincinnati Children's Hospital
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Duke University
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Region of Enrollment
United States · University of Alabama at Birmingham-Pediatrics
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Vanderbilt University Medical Center
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Washington University
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Initial Antibiotic
Amoxicillin
|
176 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
350 Participants
n=5 Participants
|
|
Initial Antibiotic
Amoxicillin Clavulanate
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Initial Antibiotic
Cefdinir
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Initial Site of Treatment
ED
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Initial Site of Treatment
Out-Patient/Urgent Care
|
151 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
304 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Intent to Treat (ITT) Population: All randomized subjects that were still eligible on Day 1 of the study. Analysis of DOOR will use all subjects in the ITT population. Subjects with missing values of DOOR will have their values imputed. However, summaries of observed ordinal clinical response values presented below are based on complete data without imputation.
DOOR is a composite endpoint created using clinical outcomes from the first 5 days and at Outcome Assessment Visit #1 (OAV #1). It is based on adequate clinical response at OAV #1, solicited symptoms from first 5 days and number of days of antibiotics use for worsening pneumonia from the first 5 days of the study.
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Desirability of Outcome Ranking (DOOR)
Death from any cause
|
0 Participants
|
0 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and no adverse events
|
97 Participants
|
107 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with mild adverse events
|
47 Participants
|
42 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with moderate adverse events
|
14 Participants
|
10 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with severe adverse events
|
0 Participants
|
2 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with persistent symptoms of fever, tachypnea, or cough
|
10 Participants
|
12 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Lack of adequate clinical response with ED/clinic visit but no hospitalization
|
2 Participants
|
1 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Lack of adequate clinical response with hospitalization
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: ITT Population: All randomized subjects that were still eligible on Day 1 of the study. Analysis of DOOR will use all subjects in the ITT population. Subjects with missing values of DOOR will have their values imputed. However, summaries of observed ordinal clinical response values presented below are based on complete data without imputation.
DOOR is a composite endpoint created using clinical outcomes from the first 18 days and at Outcome Assessment Visit #2 (OAV #2). It is based on adequate clinical response at OAV #2, solicited symptoms from first 18 days and number of days of antibiotics use for worsening pneumonia from the first 18 days of the study.
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and no solicited events
|
73 Participants
|
81 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with mild solicited events
|
53 Participants
|
51 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with moderate solicited events
|
25 Participants
|
20 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with resolution of symptoms and with severe solicited events
|
3 Participants
|
4 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Adequate clinical response with persistent symptoms of fever, tachypnea, or cough
|
7 Participants
|
8 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Lack of adequate clinical response with ED/clinic visit but no hospitalization
|
2 Participants
|
3 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Lack of adequate clinical response with hospitalization
|
0 Participants
|
0 Participants
|
|
Desirability of Outcome Ranking (DOOR)
Death from any cause
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1.
This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #1.
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Resolution of Symptoms (a Component of DOOR)
Lack of Resolution of Symptoms
|
12 Participants
|
13 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Fever
|
2 Participants
|
1 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Elevated respiratory rate
|
2 Participants
|
7 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Cough
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2.
This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #2.
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Resolution of Symptoms (a Component of DOOR)
Elevated respiratory rate
|
2 Participants
|
1 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Lack of Resolution of Symptoms
|
9 Participants
|
11 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Fever
|
0 Participants
|
3 Participants
|
|
Resolution of Symptoms (a Component of DOOR)
Cough
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1.
Lack of adequate clinical response at OAV #1 is defined as the presence of a medically attended visit to an Emergency Department (ED) or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 5.
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Adequate Clinical Response Rates (a Component of DOOR)
Lack of Adequate Clinical Response
|
2 Participants
|
1 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
ED or Clinic Visit
|
2 Participants
|
1 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Receipt of Non-Study Antibiotic
|
2 Participants
|
1 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Hospitalization
|
0 Participants
|
0 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Surgical Procedure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2.
Lack of adequate clinical response at OAV #2 is defined as the presence of a medically attended visit to an ED or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 18.
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Adequate Clinical Response Rates (a Component of DOOR)
Lack of Adequate Clinical Response
|
2 Participants
|
3 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
ED or Clinic Visit
|
4 Participants
|
2 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Receipt of Non-Study Antibiotic
|
2 Participants
|
3 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Hospitalization
|
0 Participants
|
0 Participants
|
|
Adequate Clinical Response Rates (a Component of DOOR)
Surgical Procedure
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1.
This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 5
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Reporting Solicited Symptoms
Any Event
|
74 Participants
|
68 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Irritability
|
52 Participants
|
43 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Vomiting
|
11 Participants
|
11 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Diarrhea
|
23 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Allergic Reaction
|
15 Participants
|
15 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Stomatitis
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Candidiasis
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2.
This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 18
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Reporting Solicited Symptoms
Candidiasis
|
7 Participants
|
7 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Any Event
|
91 Participants
|
89 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Irritability
|
67 Participants
|
60 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Vomiting
|
19 Participants
|
24 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Diarrhea
|
33 Participants
|
30 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Allergic Reaction
|
22 Participants
|
21 Participants
|
|
Number of Participants Reporting Solicited Symptoms
Stomatitis
|
1 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1.
This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 5
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
ED or Clinic Visit
|
2 Participants
|
1 Participants
|
|
Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
Receipt of Non-Study Antibiotic
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2.
This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 18
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
ED or Clinic Visit
|
4 Participants
|
2 Participants
|
|
Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
Receipt of Non-Study Antibiotic
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)Population: Complete Case at OAV #1. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #1, and completed OAV #1 with non-missing data for all DOOR components at OAV #1.
This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 5
Outcome measures
| Measure |
Short Course
n=170 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=174 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
ED or Clinic Visit
|
8 Participants
|
7 Participants
|
|
Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
Receipt of Non-Study Antibiotic
|
7 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)Population: Complete Case at OAV #2. This population is made of subjects who were treated with at least one dose of study product, did not terminate early from the study before OAV #2, and completed OAV #2 with non-missing data for all DOOR components at OAV #2.
This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 18
Outcome measures
| Measure |
Short Course
n=163 Participants
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=167 Participants
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
ED or Clinic Visit
|
29 Participants
|
32 Participants
|
|
Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
Receipt of Non-Study Antibiotic
|
18 Participants
|
11 Participants
|
Adverse Events
Short Course
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Standard Course
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Short Course
n=192 participants at risk
Participants will receive a short course of the initially prescribed antibiotic for 5 days plus 5 days of matching placebo
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
Placebo: Placebo
|
Standard Course
n=193 participants at risk
Participants will receive a standard course of the initially prescribed antibiotic (Amoxicillin, Amoxicillin-Clavulanate, Cefdinir) for 10 days
Amoxicillin: Amoxicillin is an aminopenicillin antibiotic
Amoxicillin-clavulanate: A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
Cefdinir: Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
|
|---|---|---|
|
General disorders
Irritability
|
38.0%
73/192 • Number of events 370 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
33.7%
65/193 • Number of events 313 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
23/192 • Number of events 41 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
14.5%
28/193 • Number of events 62 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
|
Gastrointestinal disorders
Diarrhea
|
19.3%
37/192 • Number of events 124 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
17.6%
34/193 • Number of events 125 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
|
Immune system disorders
Allergic Reaction
|
11.5%
22/192 • Number of events 98 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
11.9%
23/193 • Number of events 156 • All adverse events (AEs) that occurred from Receipt of Study Agent (Day 1) through the final Outcome Assessment Visit (Day 22 +/- 3 days) were reported.
Solicited AEs for both the Short and Standard course were assessed using MedDRA 22.0.
|
Additional Information
Dr. C. Buddy Creech
Vanderbilt Vaccine Research Program
Phone: 615-343-0332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60