Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Condition: Kerosene Pneumonitis
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.)
    

Intervention name(s): Amoxicillin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days; Placebo suspension made of water, dextrose and glycerine with a similar taste and appearance to the active comparator.
Dose 20-30mg/kg 8 hourly for 5 days
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pneumonitis; paraffin; kerosene