Text Size

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: February 1, 2012
Last verified: February 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • Length of stay in hospital [ Time Frame: Hours from admission ] [ Designated as safety issue: No ]
    For how long (hours or days) is the patient admitted to the hospital

  • Respiratory symptoms and signs [ Time Frame: At entry point, at 72 hours and 5 days post-ingestion ] [ Designated as safety issue: No ]
    Respiratory symptoms: cough or difficulty breathing Respiratory signs: chest indrawing, stridor, wheezing, crepitations or age specific tachypnoea (respiratory rate >50 breaths per minute (2 to 12 months) or respiratory rate >40 breaths per minute (12 months to 5 years)


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

  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 signs at presentation
  • Informed consent obtained from parent or legal guardian
  • Resident within the Red Cross Hospital drainage area and able to come for 2 follow-up appointments

Exclusion Criteria:

  • Too ill to be excluded from receiving antibiotics ie requiring more than 2L nasal prong oxygen (FiO2 40%), CPAP or ventilation or requiring High Care or ICU admission
  • Allergic to Amoxicillin
  Contacts and Locations
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
Last Updated: February 1, 2012
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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013