Trial Outcomes & Findings for Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia (NCT NCT04963764)
NCT ID: NCT04963764
Last Updated: 2024-02-15
Results Overview
Number of patients enrolled in Stage 2 (Randomized Pilot Trial) per site
COMPLETED
EARLY_PHASE1
5 participants
Day 7
2024-02-15
Participant Flow
Participant milestones
| Measure |
Stage 1 - Consented to Have Procalcitonin Testing Performed
Enrolled participants with procalcitonin testing performed
|
Stage 2 - Placebo
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Stage 2 - Amoxicillin
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|---|
|
Stage 1
STARTED
|
5
|
0
|
0
|
|
Stage 1
COMPLETED
|
5
|
0
|
0
|
|
Stage 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Stage 2
STARTED
|
0
|
0
|
1
|
|
Stage 2
COMPLETED
|
0
|
0
|
0
|
|
Stage 2
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Procalcitonin to Reduce Antibiotic Use in Pediatric Pneumonia
Baseline characteristics by cohort
| Measure |
Stage 2 - Placebo
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Stage 2 - Amoxicillin
n=1 Participants
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age 12-71 Months
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: The one participant in the Amoxicillin arm withdrew from the study on Day 7. There were no participants enrolled in the Placebo arm.
Number of patients enrolled in Stage 2 (Randomized Pilot Trial) per site
Outcome measures
| Measure |
Placebo
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Amoxicillin
n=1 Participants
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|
|
Total Pilot Trial Enrollment
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at completion of pilot trial (6 months)Population: Of 36 eligible participants approached, five (13.9%) provided informed consent to be included in Stage 1
Number of eligible participants approached regarding trial participation who provided informed consent to participate in Stage 1 of the trial compared with number of participants approached for participation
Outcome measures
| Measure |
Placebo
n=36 Participants
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Amoxicillin
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|
|
Consent Rate for Stage 1 (Procalcitonin Ascertainment)
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at completion of pilot trial (6 months)Population: Of 5 eligible participants who received procalcitonin in Stage 1, 3 (60%) had PCT \<0.25.
Proportion of participants who received procalcitonin in Stage 1 who had an eligible procalcitonin for Stage 2 (PCT \<0.25)
Outcome measures
| Measure |
Placebo
n=5 Participants
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Amoxicillin
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|
|
Rate of Eligible Participants for Stage 2 (Randomized Pilot Trial)
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Measured at completion of pilot trial (6 months)Population: Of the 2 eligible participants for Stage 2 who were approached, one provided informed consent for Stage 2.
Number of eligible participants for Stage 2 (PCT \<0.25) who provided informed consent to participate in Stage 2 of the trial compared with number of eligible participants approached for participation
Outcome measures
| Measure |
Placebo
n=2 Participants
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Amoxicillin
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|
|
Consent Rate for Stage 2 (Randomized Pilot Trial)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: No patients were randomized to the Placebo group. One patient withdrew from the Amoxicillin group on Day 7. Therefore, this patient was lost to follow up.
Number of enrolled participants who did not complete the Day 7 follow-up visit
Outcome measures
| Measure |
Placebo
Randomization to receive either oral placebo or amoxicillin for a standard course (10 days)
Placebo: Participants will be randomized to receive oral placebo for a standard course (10 days)
|
Amoxicillin
n=1 Participants
Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)
Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
|
|---|---|---|
|
Lost to Follow-Up at Day 7
|
0 Participants
|
1 Participants
|
Adverse Events
Stage 2 - Placebo
Stage 2 - Amoxicillin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Todd Florin
Ann & Robert H. Lurie Children's Hospital of Chicago
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place