Trial Outcomes & Findings for Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia (NCT NCT01041209)

Results Overview

The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

At baseline

Results posted on

2016-12-28

Participant Flow

Participant milestones

Participant milestones
Measure	Bacterial Pneumonia Score (BPS) Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS \> or = 4 points)	Guideline Use of antibiotics according to local enforced guidelines
Overall Study STARTED	60	60
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bacterial Pneumonia Score (BPS) Guided Antibiotic Use in Children With Community Acquired Pneumonia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bacterial Pneumonia Score (BPS) n=60 Participants Bacterial Pneumonia Score (BPS) guidance	Guideline n=60 Participants Enforced guidelines	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22.4 years STANDARD_DEVIATION 13.2 • n=5 Participants	26.1 years STANDARD_DEVIATION 13.2 • n=7 Participants	24.2 years STANDARD_DEVIATION 14.1 • n=5 Participants
Gender Female	33 Participants n=5 Participants	30 Participants n=7 Participants	63 Participants n=5 Participants
Gender Male	27 Participants n=5 Participants	30 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment Argentina	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline

The proportion of patients receiving antibiotics was compared between both groups (BPS vs Guidelines).

Outcome measures

Outcome measures
Measure	Bacterial Pneumonia Score (BPS) n=60 Participants Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS \>= 4 points	Guideline n=60 Participants Indication of antibiotics according to local (Hospital) guidelines
Use of Antibiotics in Each Group	28 participants	52 participants

SECONDARY outcome

Timeframe: 1, 2, 5, 7 and 10 days from baseline

Treatment failure was defined as: 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. Proportion of patients with treatment failure was compared between both groups (BPS vs Guideline).

Outcome measures

Outcome measures
Measure	Bacterial Pneumonia Score (BPS) n=60 Participants Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS \>= 4 points	Guideline n=60 Participants Indication of antibiotics according to local (Hospital) guidelines
Treatment Failure in Each Group	5 participants	5 participants

Adverse Events

Bacterial Pneumonia Score (BPS)

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 43070140

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place