Impact on the intestinal microbiota during antibiotic treatment

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2017
INTERVENTION: Trade Name: Ciprofloxacin Product Name: Ciprofloxacin Pharmaceutical Form: Coated tablet Trade Name: Cedax Product Name: Ceftibuten Pharmaceutical Form: Coated tablet Trade Name: Selexid Product Name: Pivmecillinam Pharmaceutical Form: Coated tablet Trade Name: Furadantin Product Name: Nitrofurantoin Pharmaceutical Form: Coated tablet Trade Name: Eusaprim forte Product Name: trimetoprim‐sulfametoxazol Pharmaceutical Form: Coated tablet CONDITION: Impact on the intestinal microbiota during antibiotic treatment Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: ; Main Objective: The objective of the study is: (1) to identify the composition and diversity of the intestinal microbiota and the presence of resistant bacteria and resistance genes, before and up to 1 years after antibiotic treatment (2) and to compare the impact of three different antibiotics (ciprofloxacin, pivmecillinam och ceftibuten) on the microbiota.; Primary end point(s): The primary endoint is the diversity and composition of the intestinal microbiota, the prevalence of multi drug‐resistant Gram‐negative bacteria in screening cultures and the prevalence of antibiotic resistance genes in faeces. Secondary Objective: Not applicable Timepoint(s) of evaluation of this end point: Endpoints will be assessed at repeated time points during the study period: before start of treatment, after completion of treatment, after 7 days and 1, 3, 6 and 12 month after completion of treatment. SECONDARY OUTCOME: Secondary end point(s): Not applicable Timepoint(s) of evaluation of this end point: Not applicable INCLUSION CRITERIA: ‐ At least 18 years of age ‐ Signed written informed consent 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: a9e0042e47c08ba1afaf286609889601789041cb
First added on: Aug 24, 2024