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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
PACTR201201000259370 |
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Date of registration:
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28/10/2010 |
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Primary sponsor: |
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Public title:
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The efficacy of prophylactic antibiotics in the management of pneumonitis following paraffin ingestion in children
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Scientific title:
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The efficacy of prophylactic antibiotics in the management of pneumonitis following paraffin ingestion in children |
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Date of first enrolment:
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2010-07-21 |
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Target sample size:
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74 |
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Recruitment status: |
Completed: recruitment & data analysis complete |
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URL:
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HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201201000259370 |
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Study type:
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interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,
Randomised,
Simple randomisation using a table created by a computer software program,
Numbered containers,
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Countries of recruitment
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South Africa
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Contacts
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Name:
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Kate
Balme |
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Address:
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Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
7700
Cape Town
South Africa |
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Telephone:
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021 658 5308 |
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Email:
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kh.balme@uct.ac.za |
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Affiliation:
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Name:
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Kate
Balme |
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Address:
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Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
7700
Cape Town
South Africa |
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Telephone:
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021 658 5308 |
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Email:
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kh.balme@uct.ac.za |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Ingested paraffin in the preceding 24 hours
Presence of respiratory symptoms or signs
Informed consent by parent/legal guardian
Resident within the hospital drainage area and able to come for 2 follow up appointments
Exclusion criteria: 1. Asymptomatic and no clinical signs
2. Too ill to be excluded from receiving an antibiotic as judged by:
o Requiring more than 2L/min nasal-prong oxygen
o Requiring continuous or intermittent positive airway pressure ventilation
o Fever b 40?C
3. Needing an antibiotic for another reason e.g. otitis media, tonsillitis
4. Current antibiotic use, prior to kerosene ingestion
5. Allergic to amoxicillin
Age minimum:
3 Month
Age maximum:
13 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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paraffin (kerosene) poisoning
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Primary Outcome(s)
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Treatment failure
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Secondary Outcome(s)
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Length of stay in hospital
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Presence of respiratory symptoms and signs
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Secondary ID(s)
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NCT01253980
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REC REF 095/2010
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Source(s) of Monetary Support
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Institute of Child Health, UCT
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