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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kate Balme, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01253980
First received: December 3, 2010
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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 Intervention
Kerosene Pneumonitis
Drug: Amoxicillin
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Prophylactic Antibiotics in the Management of Pneumonitis Following Paraffin (Kerosene) Ingestion in Children

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • Treatment Failure [ Time Frame: At routine follow-up 3 and 5 days post-ingestion or earlier if necessary ] [ Designated as safety issue: No ]
    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.


Enrollment: 74
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amoxicillin
Amoxicillin
Drug: Amoxicillin
Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days
Placebo Comparator: Placebo suspension
Placebo
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


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.)

  Eligibility

Ages Eligible for Study:   3 Months to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253980

Locations
South Africa
Red Cross War Memorial Children's Hospital
Cape Town, Western Cape, South Africa, 7700
Sponsors and Collaborators
University of Cape Town
Investigators
Study Director: Heather Zar, MBBCh PhD University of Cape Town
Study Director: Michael D Mann, MMed Paed PhD University of Cape Town
  More Information

No publications provided

Responsible Party: Kate Balme, Dr, University of Cape Town
ClinicalTrials.gov Identifier: NCT01253980     History of Changes
Other Study ID Numbers: 095/2010, PACTR201201000259370
Study First Received: December 3, 2010
Results First Received: May 6, 2013
Last Updated: June 25, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Cape Town:
pneumonitis
paraffin
kerosene

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014