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

NCT01253980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2015-11-09

Study results available
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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.

Conditions

  • Kerosene Pneumonitis

Interventions

DRUG

Amoxicillin

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

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

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Heather Zar, MBBCh PhD · University of Cape Town

  • Michael D Mann, MMed Paed PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01253980 on ClinicalTrials.gov