Resistance to anitbiotics MedDRA version: 16.1 Level: LLT Classification code 10004052 Term: Bacterial resistance System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Azithromycin "Teva"
Product Name: Azithromycin "Teva"
Pharmaceutical Form: Tablet
INN or Proposed INN: Azithromycin
Other descriptive name: AZITHROMYCIN
Concentration unit: mg milligram(s)
Sponsors
Department of Medicine, Køge University Hospital
Department of Medicine, Køge University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is between 18 and 65 years of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 2. Subject has taken antibiotics in the last 12 months (by self-report) 3. Subject has experienced allergic reactions to antibiotic class used in the study 4. Subject has special dietary habits (vegetarian or vegan) 5. Do not report regular bowel movements at least 5 days per week 6. Pregnant or lactating or wish to become pregnant during the period of the study. 7. Not using secure birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To elucidate the dynamics of the gut metagenome upon exposure to antibiotics;Secondary Objective: To identify the role of Bacteriophages in developement of resistance to antibiotics ;Primary end point(s): Change in the gut metagenome ;Timepoint(s) of evaluation of this end point: 2,4,15,30,90 days after strat of antibiotic treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): antibiotic resistance determinants carried on phages;Timepoint(s) of evaluation of this end point: 2,4,15,30,90 days after strat of antibiotic treatment | — |
Countries
Denmark
Contacts
Public ContactPeter Bytzer
Department of Medicine, Køge University Hospital
Outcome results
None listed