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

NCT01253980 | Completed Results DMC

• 2 other identifiers: 095/2010PACTR201201000259370
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Kerosene Pneumonitis

Keywords

pneumonitis; paraffin; kerosene

Outcome Measures

Primary Outcomes (1)

• Treatment Failure

  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.

  At routine follow-up 3 and 5 days post-ingestion or earlier if necessary

Study Arms (2)

Amoxicillin

ACTIVE COMPARATOR

Amoxicillin

Drug: Amoxicillin

Placebo suspension

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Amoxicillin DRUG

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

Amoxicillin

Placebo 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

Placebo suspension

Eligibility Criteria

• Age: 3 Months - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Red Cross War Memorial Children's Hospital

Cape Town, Western Cape, 7700, South Africa

Location

Related Publications (1)

• 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.

  PMID: 26114347 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination leading to small number of participants. Some patients did not attend follow-up and were only contacted by phone, therefore clinical data not available for all participants at follow-up.

Results Point of Contact

• Title: Dr Kate Balme
• Organization: Poisons Information Centre, Red Cross War Memorial Children's Hospital and University of Cape Town

kate.balme@uct.ac.za

+27 21 658 5308

Study Officials

• Heather Zar, MBBCh PhD

  University of Cape Town

  STUDY DIRECTOR

• Michael D Mann, MMed Paed PhD

  University of Cape Town

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 6, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 9, 2015
• Results First Posted: June 26, 2013

Record last verified: 2015-10

Locations

ZA (1)