Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
2
VRE Carriage, ESBL Carriage
To evaluate the dynamics of carriage [of resistant bacteria] upon introduction of antibiotic challenge.
Key facts
- Sponsor
- Region Uppsala
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 25 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Gävleborg county
External identifiers
- EU CT number
- 2024-517434-17-01
- EudraCT number
- 2019-000244-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
To evaluate the dynamics of carriage [of resistant bacteria] upon introduction of antibiotic challenge.
Secondary objectives 1
- To more generally evaluate changes in the composition of the intestinal flora during the administration of antibiotics.
Conditions and MedDRA coding
VRE Carriage, ESBL Carriage
Regulatory references
- Plan to share IPD
- Yes
- IPD plan description
- IPD that underlie results in publication
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-517434-17-00 | Influence of antibiotic treatment on the normal flora and the presence of resistance genes in known carriers of ESBL and VRE | Region Uppsala |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Signed consent, >18 years of age, Verified carriage of VRE/EPE in screening or clinical culture, Negativity in latest screening for VRE/EPE, For EPE carriers the isolate must be ressitant (R) to ciprofloxacin, Adquate contraception for fertile women (as recommended bythe CTFG)
Exclusion criteria 1
- Known allergy to ciprofloxacin or contraindication for ciprofloxacin treatmen (for EPE arm), kidney failure as defined by creatinin clearance < 30 ml/min/1,73 m3 or serum creatinin > 168 µmol (for EPE arm), significant interaction with ciprofloxacin (EPE arm), known allergy or contraindication for vancomycin (VRE arm), pregnancy or breastfeeding, other morbidity or condition which makes the person ineligible for inklusion
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1 a) Transition from negative to positive fecal screen for VRE/EPE directly after antibiotic challenge. 1b) Differences in the microbiota's composition and diversity compared to before antibitoic challenge.
Secondary endpoints 1
- 2a) Time for participants who transitioned from negative to positive VRE/EPE carriage to transition back to negative. 2b) Time for the intestinal microbiota's composition and diversity to return to baseline. 2c) Differences regarding detection of resistance in with conventional methods compared to metagenomic methods, defined as discordant results.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB05076MIG · Substance
- Active substance
- Vancomycin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 2500 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07470MIG · Substance
- Active substance
- Ciprofloxacin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 5000 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Uppsala
- Sponsor organisation
- Region Uppsala
- Address
- Storgatan 27, Uppsala Domkyrkofors. Uppsala Domkyrkofors.
- City
- Uppsala
- Postcode
- 753 31
- Country
- Sweden
Scientific contact point
- Organisation
- Region Uppsala
- Contact name
- Regionens hus, Uppsala
Public contact point
- Organisation
- Region Uppsala
- Contact name
- Regionens hus, Uppsala
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 60 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Sweden | 2024-10-25 | 2024-10-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Studieprotokoll redacted | 3 |
| Recruitment arrangements (for publication) | Godkand av EPM | 1 |
| Subject information and informed consent form (for publication) | Information till forskningspersoner | 2 |
| Subject information and informed consent form (for publication) | Samtyckesformular | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Ciprofloxacin Accord | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-15 | Sweden | Acceptable 2024-10-25
|
2024-10-25 |