Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
Research Ethics Number (La Trobe University): 00/124
Study information
Scientific title
Acronym
ROBIn (Reduction of Breast Infection) Trial
Study hypothesis
The aim of our study was to prevent mastitis in breastfeeding women with cracked nipples colonised with S. aureus. The hypothesis was that a course of antibiotics would reduce mastitis in breastfeeding women with cracked nipples colonized with S. aureus. Participating women were randomised to receive a seven-day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Mastitis (prevention of) in lactating women
Intervention
Women with nipple swab positive for Staphylococcus aureus are randomised to receive a seven-day course of:
1. Flucloxacillin 500 mg qid, or
2. Identical placebo capsules
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Flucloxacillin
Primary outcome measure
Incidence of mastitis in each group in the week following recruitment.
Secondary outcome measures
Nipple healing, nipple pain.
Overall study start date
01/11/2001
Overall study end date
30/11/2002
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Breastfeeding women with at least one damaged nipple
2. English-speaking
3. Live in Melbourne
4. Not allergic to penicillin
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
10
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/11/2001
Recruitment end date
30/11/2002
Locations
Countries of recruitment
Australia
Study participating centre
Director
Carlton
VIC 3053
Australia
Sponsor information
Organisation
La Trobe University (Australia)
Sponsor details
Faculty of Health Sciences
Melbourne
VIC 3086
Australia
+61 (0)3 9479 3583
lhs@latrobe.edu.au
Sponsor type
University/education
Website
http://www.latrobe.edu.au/health/healthsci_schoolcent.html
ROR
Funders
Funder type
Research council
Funder name
Medical Research Foundation for Women and Babies, Melbourne (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Australian National Health and Medical Research Council Public Health scholarship (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Antibiotics provided by CSL Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 16/09/2004 | Yes | No |