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Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01253980
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : June 26, 2013
Last Update Posted : November 9, 2015
Information provided by (Responsible Party):
Kate Balme, University of Cape Town

Brief 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.

Condition or disease Intervention/treatment Phase
Kerosene Pneumonitis Drug: Amoxicillin Drug: Placebo Not Applicable

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.)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Prophylactic Antibiotics in the Management of Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Study Start Date : July 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Amoxicillin
Drug: Amoxicillin
Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days

Placebo Comparator: Placebo suspension
Drug: Placebo

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

Primary Outcome Measures :
  1. Treatment Failure [ Time Frame: At routine follow-up 3 and 5 days post-ingestion or earlier if necessary ]
    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.

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Ages Eligible for Study:   3 Months to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ingestion in the preceding 24 hours
  • Presence of respiratory symptoms and/or signs at presentation
  • Informed consent obtained from parent or legal guardian
  • Resident within the Red Cross Hospital drainage area and able to come for two follow-up appointments

Exclusion Criteria:

  • Asymptomatic and no clinical signs
  • Too ill to be excluded from receiving an antibiotic as judged by:

    • Requiring more than 2L/min nasal-prong oxygen
    • Requiring continuous or intermittent positive airway pressure ventilation
    • Fever > 40˚C
  • Needing an antibiotic for another reason e.g. otitis media, tonsillitis
  • Current antibiotic use, prior to kerosene ingestion
  • Allergic to amoxicillin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01253980

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South Africa
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa, 7700
Sponsors and Collaborators
University of Cape Town
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Study Director: Heather Zar, MBBCh PhD University of Cape Town
Study Director: Michael D Mann, MMed Paed PhD University of Cape Town
Publications of Results:
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Responsible Party: Kate Balme, Dr, University of Cape Town Identifier: NCT01253980    
Other Study ID Numbers: 095/2010
PACTR201201000259370 ( Registry Identifier: Pan African Clinical Trial Registry )
First Posted: December 6, 2010    Key Record Dates
Results First Posted: June 26, 2013
Last Update Posted: November 9, 2015
Last Verified: October 2015
Keywords provided by Kate Balme, University of Cape Town:
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents