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

NCT ID: NCT01253980

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-09-30

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.

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.)

Conditions

Kerosene Pneumonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Amoxicillin

Amoxicillin

Group Type: ACTIVE_COMPARATOR

Amoxicillin

Intervention Type: DRUG

Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days

Placebo suspension

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Amoxicillin

Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Kate Balme

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heather Zar, MBBCh PhD

Role: STUDY_DIRECTOR

University of Cape Town

Michael D Mann, MMed Paed PhD

Role: STUDY_DIRECTOR

University of Cape Town

Locations

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, South Africa

Countries

South Africa

References

Balme KH, Zar H, Swift DK, Mann MD. The efficacy of prophylactic antibiotics in the management of children with kerosene-associated pneumonitis: a double-blind randomised controlled trial. Clin Toxicol (Phila). 2015;53(8):789-96. doi: 10.3109/15563650.2015.1059943. Epub 2015 Jun 26.

Reference Type: RESULT

PMID: 26114347 (View on PubMed)

Other Identifiers

PACTR201201000259370

Identifier Type: REGISTRY

Identifier Source: secondary_id

095/2010

Identifier Type: -

Identifier Source: org_study_id