Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201201000259370 Date of Approval: 28/10/2010
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The efficacy of prophylactic antibiotics in the management of pneumonitis following paraffin ingestion in children
Official scientific title The efficacy of prophylactic antibiotics in the management of pneumonitis following paraffin ingestion in children
Brief summary describing the background and objectives of the trial Paraffin 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 children that the use of antibiotics improves the clinical outcome in paraffin (kerosene)induced pneumonitis. This randomised placebo controlled trial will investigate whether the use of a prophylactic antibiotic affects the clinical course of children with pneumonitis following paraffin ingestion
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Paediatrics,paraffin poisoning,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 21/07/2010
Actual trial start date 21/07/2010
Anticipated date of last follow up 20/06/2012
Actual Last follow-up date 26/09/2011
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 74
Recruitment status Completed
Publication URL http://www.ncbi.nlm.nih.gov/pubmed/26114347
Secondary Ids Issuing authority/Trial register
REC REF 095/2010 UCT Faculty of Health Sciences Human Research Ethics Committee
NCT01253980 ClinicalTrials.gov
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used
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 Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Amoxicillin 20-30mg per kg 8 hourly 5 days Antibiotic 100
Control Group Placebo 20-30mg/kg 8 hourly 5 days Mixture of water, dextrose powder and glyerine with similar appearance and taste as experimental group and prepared by the hospital pharmacy 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 > 40 degrees Celsius 3. Needing an antibiotic for another reason e.g. otitis media, tonsillitis 4. Current antibiotic use, prior to kerosene ingestion 5. Allergic to amoxicillin 3 Month(s) 13 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/03/2010 UCT Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Length of stay in hospital Length of stay - at discharge
Primary Outcome Treatment failure At follow-up at 3 and 5 days post-ingestion, or before if necessary.
Secondary Outcome Reported symptoms and clinical signs, specifically related to the respiratory system At follow-up at 3 and 5 days post-ingestion
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memorial Children's Hospital Klipfontein Road, Rondebosch Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Institute of Child Health, UCT Klipfontein Road, Rondebosch Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Kate Balme Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
Primary Sponsor Dr Kate Balme Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Michael Mann UCT Department of Paediatrics and Child Health, Klipfontein Road, Rondebosch Cape Town 7700 South Africa
Prof Heather Zar UCT Department of Paediatrics and Child Health, Klipfontein Road, Rondebosch Cape Town 7700 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kate Balme kh.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
Role Name Email Phone Street address
Principal Investigator Kate Balme kate.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
Role Name Email Phone Street address
Public Enquiries Kate Balme kate.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
Role Name Email Phone Street address
Public Enquiries Kate Balme kh.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
Role Name Email Phone Street address
Scientific Enquiries Kate Balme kh.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
Role Name Email Phone Street address
Scientific Enquiries Kate Balme kate.balme@uct.ac.za 021 658 5308 Red Cross War Memorial Children's Hospital, Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa
REPORTING
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