Trial Outcomes & Findings for Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children (NCT NCT01253980)
NCT ID: NCT01253980
Last Updated: 2015-11-09
Results Overview
A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.
COMPLETED
NA
74 participants
At routine follow-up 3 and 5 days post-ingestion or earlier if necessary
2015-11-09
Participant Flow
Recruitment period: 21 July 2010 - 21 September 2011 (24 hours a day) Patients recruited from Medical Emergency Department
Participant milestones
| Measure |
Placebo
Placebo 20-30mg per kg 8 hourly for 5 days
|
Amoxicillin
Amoxicillin 20-30mg per kg 8 hourly for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
39
|
|
Overall Study
COMPLETED
|
35
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Baseline characteristics by cohort
| Measure |
Placebo
n=35 Participants
Placebo 20-30mg per kg 8 hourly for 5 days
|
Amoxicillin
n=39 Participants
Amoxicillin 20-30mg per kg 8 hourly for 5 days
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
19 months
n=99 Participants
|
20 months
n=107 Participants
|
19 months
n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
35 participants
n=99 Participants
|
39 participants
n=107 Participants
|
74 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At routine follow-up 3 and 5 days post-ingestion or earlier if necessaryPopulation: per protocol
A treatment failure was a patient who at any time deteriorated necessitating a change to the treatment regimen. This was determined by assessing reported symptoms (cough, shortness of breath, wheeze and fever) and comparing clinical signs (respiratory rate, oxygen saturation, wheeze, flaring, grunting, recessions, crepitations, temperature, mental status) to signs at presentation.
Outcome measures
| Measure |
Placebo
n=35 Participants
Placebo 20-30mg per kg 8 hourly for 5 days
|
Amoxicillin
n=39 Participants
Amoxicillin 20-30mg per kg 8 hourly for 5 days
|
|---|---|---|
|
Treatment Failure
|
3 participants
Interval 3.0 to 22.0
|
2 participants
Interval 1.0 to 17.0
|
Adverse Events
Placebo
Amoxicillin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Kate Balme
Poisons Information Centre, Red Cross War Memorial Children's Hospital and University of Cape Town
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place