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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

At routine follow-up 3 and 5 days post-ingestion or earlier if necessary

Results posted on

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

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

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=5 Participants
39 Participants
n=7 Participants
74 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
19 months
n=5 Participants
20 months
n=7 Participants
19 months
n=5 Participants
Sex: Female, Male
Female
14 Participants
n=5 Participants
15 Participants
n=7 Participants
29 Participants
n=5 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
24 Participants
n=7 Participants
45 Participants
n=5 Participants
Region of Enrollment
South Africa
35 participants
n=5 Participants
39 participants
n=7 Participants
74 participants
n=5 Participants

PRIMARY outcome

Timeframe: At routine follow-up 3 and 5 days post-ingestion or earlier if necessary

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Amoxicillin

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 Kate Balme

Poisons Information Centre, Red Cross War Memorial Children's Hospital and University of Cape Town

Phone: +27 21 658 5308

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place