Kerosene Pneumonitis Clinical Trial
Official title:
The Efficacy of Prophylactic Antibiotics in the Management of Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Paraffin (kerosene) ingestion in the developing world accounts for a large number of visits to healthcare facilities, especially amongst children. There is no evidence in animals and no good evidence in humans that the use of early antibiotics improves the clinical outcome of paraffin-induced pneumonitis. This randomised placebo-controlled trial will investigate whether the use of early antibiotics affects the clinical course of children with pneumonitis following paraffin ingestion.
The average of 100 children per annum attending Red Cross War Memorial Children's Hospital
9RCWMCH) with the diagnosis of kerosene ingestion would give a sample of 200 children over a
two-year period, with 100 patients in each group. From a postulated secondary infection rate
of 15 to 50% for children not receiving an antibiotic, a midway point of 25% estimated the
treatment failure rate in the placebo group. With no information available on the treatment
failure rate in the active group, failure rates of 10% and 5% were arbitrarily applied. With
25% and 5% treatment failure rates for placebo and active groups respectively, at a level of
significance of α = 0.05 a sample size of 100 per group gives a power of 0.98 and with
failure rates of 25% and 10% a power of 0.80.
Statistical analysis was done using IBM SPSS Version 20 (SPSS Inc., Chicago, IL, USA).
Categorical variables are expressed as n (%) and continuous variables as median
(interquartile range (IQR)). A P value of ≤ 0.05 was considered significant for all
situations. For categorical variables, Fischer's exact test was used for small samples or
less frequent occurrences. Chi-Square testing was applied for larger samples or more
frequent occurrences. Mann-Whitney or Kruskal-Wallis tests were used for ordinal and
continuous variables. Significant correlation between factors and covariates (Spearman's
rank coefficient) favoured univariate analysis over binary logistic regression modelling to
determine potential risk factors for treatment failure. Continuous variables were
categorised for clinical relevance or logistic regression testing. In some instances,
specific clinical parameters or reported symptoms were not recorded or the presence or
absence of a risk factor was unknown. The missing values, unknown factors and the flow of
patient follow-up account for totals not always adding up to the full number of study
participants. In the results for Day 3 and Day 5 post-ingestion, the denominator used to
calculate proportions for reported symptoms included those patients who attended and who
were telephone interviewed, whereas the denominator for clinical signs was only the patients
who attended.
The primary outcome measure was treatment failure, as reported. Secondary outcome measures
were length of hospital stay, reported symptoms (cough, shortness of breath, wheeze and
fever) and clinical signs (respiratory rate, flaring, recessions, grunting, wheeze,
crepitations, temperature and altered mental status) at follow-up at Day 3 and 5
post-ingestion for placebo and active groups. Further investigation explored the role of
confounding conditions (upper respiratory tract infection, active Mycobacterium tuberculosis
infection) and risk factors for treatment failure or delayed resolution (vomiting
post-ingestion, household smoking contact, HIV exposure status, prior respiratory history,
young age etc). Secondary outcome measures, confounding conditions and risk factors are not
reported in this Clinical Trials format, but are reported in the PI's Master's thesis.
(Balme KH. The efficacy of prophylactic antibiotics in the management of pneumonitis
following paraffin (kerosene) ingestion in children [Master's thesis]. [Cape Town]:
University of Cape Town; 2013. 113 p.)
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment