N/A
N=74
Antibiotic Efficacy in Pneumonitis Following Paraffin (Kerosene) Ingestion in Children
Kerosene Pneumonitis
Bottom Line
View on ClinicalTrials.gov: NCT01253980 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Treatment Failure — 3; 2 participants — p=>0.50
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amoxicillin (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Cape Town
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure |
3; 2 | >0.50 |
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.
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
Data sourced from ClinicalTrials.gov (NCT01253980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.