Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000592448
Ethics application status
Approved
Date submitted
14/11/2007
Date registered
19/11/2007
Date last updated
23/06/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Is cotrimoxazole safe and efficacious for treatment of skin sores in Aboriginal children: a pilot study
Scientific title
In Aboriginal children in remote communities, is oral cotrimoxazole as safe and efficacious as intramuscular benzathine penicillin, in achieving resolution of skin sores?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impetigo 2553 0
Condition category
Condition code
Infection 2653 2653 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral cotrimoxazole 4+20 mg/kg (up to 160/800mg) twice daily for 5 days
Intervention code [1] 2284 0
Treatment: Drugs
Comparator / control treatment
Intramuscular benzathine penicillin 45mg/kg (up to 900mg) as a single dose
Control group
Active

Outcomes
Primary outcome [1] 3563 0
Successful treatment (healed or improved) of skin sores
Timepoint [1] 3563 0
Day 7 after commencement of treatment
Secondary outcome [1] 5963 0
Bacterial resolution of skin sores
Timepoint [1] 5963 0
Day 4 and 7
Secondary outcome [2] 5964 0
Evidence of allergy or other adverse effect to study medications
Timepoint [2] 5964 0
Up till day 7

Eligibility
Key inclusion criteria
Diagnosis of purulent or crusted impetigo.
Minimum age
2 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Receipt of any antibiotic in the previous seven days, or receipt of benzathine penicillin in the previous 30 days.
2. The presence of impetigo lesions that are only “flat-dry” (i.e. lesions that are not purulent or crusted)
3. Known allergy to penicillin, sulphonamide drugs or trimethoprim, or other constituents of study medications.
4. Immunocompromised.
5. Acute or chronic dermatosis.
6. Evidence of sepsis, cellulitis, bullous impetigo, boils or carbuncles.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
We will recruit children from households in a remote Aboriginal community. Households will be screened for children with skin sores. Eligible children with impetigo, and their parents/guardians, will be approached for written, informed consent.
Eligible children will be randomised by the use of sealed, sequentially marked,
opaque envelopes in accordance with the CONSORT statements. Randomisation will be by permuted block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 322 0
0810

Funding & Sponsors
Funding source category [1] 2796 0
Charities/Societies/Foundations
Name [1] 2796 0
Menzies School of Health Research
Country [1] 2796 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Menzies School of Health Research
Address
PO Box 41096
Casuarina NT 0811
Country
Australia
Secondary sponsor category [1] 2527 0
None
Name [1] 2527 0
Address [1] 2527 0
Country [1] 2527 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4714 0
Northern Territory Department of Health and Community Services and Menzies School of Health Research
Ethics committee address [1] 4714 0
Menzies School of Health Research
Ethics committee country [1] 4714 0
Australia
Date submitted for ethics approval [1] 4714 0
14/11/2007
Approval date [1] 4714 0
12/12/2007
Ethics approval number [1] 4714 0
07/84

Summary
Brief summary
We aim to conduct a pilot study to determine the efficacy and safety of oral cotrimoxazole compared to benzathine penicillin (BPG), for the treatment of skin sores(also known as impetigo) in children living in a remote Aboriginal community in the Northern Territory. Cotrimoxazole may be a much more acceptable oral alternative compared to the uncomfortable and poorly received intramuscular benzathine penicillin which is the current standard of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28187 0
Address 28187 0
Country 28187 0
Phone 28187 0
Fax 28187 0
Email 28187 0
Contact person for public queries
Name 11344 0
Steven Tong
Address 11344 0
PO Box 41096
Casuarina NT 0811
Country 11344 0
Australia
Phone 11344 0
+61 8 89228196
Fax 11344 0
Email 11344 0
[email protected]
Contact person for scientific queries
Name 2272 0
Steven Tong
Address 2272 0
PO Box 41096
Casuarina NT 0811
Country 2272 0
Australia
Phone 2272 0
+61 8 89228196
Fax 2272 0
Email 2272 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.