Trial Outcomes & Findings for Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine (NCT NCT01875731)
NCT ID: NCT01875731
Last Updated: 2017-03-03
Results Overview
Number of participants with use of any antibiotic, at any time after diagnosis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
At day 7 from baseline
Results posted on
2017-03-03
Participant Flow
Participant milestones
| Measure |
BPS (Bacterial Pneumonia Score)
Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
|
Guideline
Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
32
|
|
Overall Study
COMPLETED
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BPS (Bacterial Pneumonia Score)
Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
|
Guideline
Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use
|
|---|---|---|
|
Overall Study
Fail to obtain lab sample
|
1
|
0
|
Baseline Characteristics
Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Pneumonia and Pneumococcal Vaccine
Baseline characteristics by cohort
| Measure |
BPS (Bacterial Pneumonia Score)
n=33 Participants
Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
|
Guideline
n=32 Participants
Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.2 months
STANDARD_DEVIATION 10.2 • n=5 Participants
|
17.5 months
STANDARD_DEVIATION 11 • n=7 Participants
|
17.5 months
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Gender
Female
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At day 7 from baselineNumber of participants with use of any antibiotic, at any time after diagnosis
Outcome measures
| Measure |
BPS (Bacterial Pneumonia Score)
n=33 Participants
Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
|
Guideline
n=32 Participants
Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use
|
|---|---|---|
|
Use of Antibiotics in Each Group
|
9 participants
|
21 participants
|
SECONDARY outcome
Timeframe: 1, 2, 5, 7 and 10 days from baselineNumber of participants with persistence of fever after 2 days, or tachypnea or diminishing in respiratory rate less than 5 bpm. after 2 days, or signs of severe pneumonia or requiring or changing antibiotics at any time.
Outcome measures
| Measure |
BPS (Bacterial Pneumonia Score)
n=33 Participants
Strategy based on BPS guided antibiotic use
BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
|
Guideline
n=32 Participants
Strategy based on enforced guideline guided antibiotic use
Guideline: Strategy based on enforced guideline guided antibiotic use
|
|---|---|---|
|
Treatment Failure in Each Group
|
3 participants
|
4 participants
|
Adverse Events
BPS (Bacterial Pneumonia Score)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Guideline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Fernando Torres
Hospital General de Niños Pedro de Elizalde
Phone: +54 11 43632100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place