Clinical trial · Observational
Amplification and Selection of Antimicrobial Resistance in the Intestine
Self-controlled Cohort Study of the Amplification and Selection of Antimicrobial Resistance in the Human Intestine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The worldwide increase in the incidence of multidrug-resistant (MDR) pathogens is alarming. Antimicrobial treatment is a risk factor for the isolation of MDR pathogens and can therefore contribute to the observed trend. Differences in the degree of selection pressure caused by various antimicrobials have not been systematically investigated until today. The aim of the proposed project is the determination of the impact of antibiotic treatment on the copy number of resistance genes in the human intestinal microbiome using metagenome shotgun sequencing. The resistance gene count in the gastrointestinal tract will be determined in a clinical cohorts of patients treated with either ciprofloxacin or cotrimoxazol as monotherapy. The subsequent quantification and comparison of the selection pressure facilitates the application of antibiotics with a lower potential to select for resistance. To achieve this goal, a self-controlled, prospective observational epidemiological study will be performed at two centres of the German Centre for Infection Research (Tübingen, Cologne).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukaemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Changes from Baseline of Antimicrobial Resistance Gene Content in the human Intestine at three Time Points with respect to different Antibiotic Treatment Regimes.
- timeFrame
- day 0, day 1, day 3, end of antimicrobial treatment
- description
- Stool samples will be collected from patients at four time points: t0 (baseline) The time point serves as a control. The stool sample will be obtained before treatment start. t1 (early phase) The time point reflects the early phase at day 1 of treatment with either ciprofloxacin or cotrimoxazol. t2 (early-late phase) The time point reflects the early-late phase at day 3 of treatment. t3 (late phase) The time point reflects the end of treatment (max. day 7).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * male or female patients ≥ 18 years * patients with acute leukaemia * admission to one of the 2 study centres * obtained written consent Exclusion Criteria: * treatment with antibiotics in the previous 30 days * pregnancy * patients currently treated for HIV and/or hepatitis b/c * patients who can not estimate scope and consequences of their participation in the study * patients who will most likely not be able to follow the study protocol
References
Publications (1)
- DERIVEDWillmann M, Vehreschild MJGT, Biehl LM, Vogel W, Dorfel D, Hamprecht A, Seifert H, Autenrieth IB, Peter S. Distinct impact of antibiotics on the gut microbiome and resistome: a longitudinal multicenter cohort study. BMC Biol. 2019 Sep 18;17(1):76. doi: 10.1186/s12915-019-0692-y. PMID 31533707