Antibiotic Resistant Bacteria Clinical Trial
Official title:
Phase 4 Study Into the Effect of Minocycline and Amoxicillin Administration of the Prevalence of Antibiotic Resistant Bacteria and on the Indigenous Oral, Faecal, Cutaneous and Nasal Microbiotas
A randomised, open labelled study design is selected in order to determine the emergence and
persistence of antibiotic resistant bacteria in humans and on the composition of the
indigenous microbiotas at various body sites. These will involve the administration to
volunteers of minocycline and amoxicillin- a control group will receive a placebo.
Microbiology of the skin, saliva, faecal, skin and nasal micro flora, safety and adverse
events, vital signs, will be evaluated. The objectives of metagenomic analysis are:
- To identify the in vivo molecular mechanisms responsible for antibiotic resistance and
its transfer in the indigenous oral and faecal microbiotas using metagenomics resistome
analysis.
- To determine the impact of the use of antimicrobial agents on the oral resistome
- To determine the impact of the use of antimicrobial agents on the faecal resistome
- To determine the ecological impact of the use of antimicrobial agents on the relative
abundance of phylotypes of the indigenous oral microbiota
- To determine the ecological impact of the use of antimicrobial agents on the relative
abundance of phylotypes of the indigenous faecal microbiotas
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research