Carbapenemase-producing Enterobacteriaceae InfectionPhase 2KAPEDISNCT04760665
Clinical Trial to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Carbapenemase-producing Klebsiella Pneumoniae
A Phase 2 study testing Fecal microbiota transplantation in people with Carbapenemase-producing Enterobacteriaceae Infection, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carbapenemase-producing Enterobacteriaceae Infection
- What is being tested?
- Fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- 4 Oct 2021to 24 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> = 18 years.
- Signature of the informed consent by the patient or legally designated person
- Absence of active infection by carbapenemase-type KPC-producing Klebsiella pneumoniae at the time of assessment as well as in the month prior to inclusion in the study
Who cannot join
- Terminal situation, or estimated life expectancy of less than 3 months
- Pregnant or lactating women
- Intolerance or inability to take oral medication at the time of assessment
- History of aspiration or dysphagia
- Patients with a history of colectomy, colostomy or ileostomy
- Patients who are receiving or have received antibiotics in the month prior to the inclusion assessment
Show all 14Show fewer
- Neutrophil count less than 500 cells / mm3
- Anticipation of the use of myelosuppressive treatment (eg. dexamethasone, chemotherapy against to solid tumors or prior to transplantation of hematopoietic progenitories) within 30 days after inclusion in the study
- Hematopoietic stem cell transplantation in the month prior to inclusion in the study
- Presence of clinical signs of mucositis
- Forecast of major abdominal surgical intervention in the month following inclusion in the study
- Patients with a Gianella Score> 12 points
- History of having received decolonization guidelines in the previous 3 months
- Severe food allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing
Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial.
The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction.
Read more
Secondary objectives are:
- To evaluate the safety of FMT.
- To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT.
- To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention.
- To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention.
- To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.
- Being tested
- Fecal microbiota transplantation, Placebo
- Keywords
- fecal microbiota transplantation, Klebsiella pneumoniae, carbapenemase, intestinal colonization, decolonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationBiological
Patients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients.
PlaceboOther
Patients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Not described Receives: Biological: Fecal microbiota transplantation |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decolonization
Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.
Measured: 30 days after treatment.
Secondary outcomes (5)
Percentage of patients with adverse effects
Percentage of patients with adverse effects
Measured: 90 days after treatment.
Bacterial load
Amount of KPC-producing Klebsiella pneumoniae (Kp-KPC) after intervention
Measured: 7 days and 30 days after treatment.
Persistent intestinal decolonization
Persistence of intestinal decolonization 90 days after intervention
Measured: 90 days after treatment.
Infections caused by Kp-KPC
Percentage of patients with infections caused by Kp-KPC after intervention
Measured: 90 days after treatment.
Mortality
Percentage of patients died after intervention
Measured: 90 days after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start4 Oct 2021
- Primary completion24 Nov 2023
- Study completion24 Nov 2023
Why it stopped: lack of elegible population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carbapenemase-producing Enterobacteriaceae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Mikrobiomik Healthcare Company S.L.
- Responsible party
- Sponsor
- Investigators
- Juan José Castón Osorio, MD, Principal investigator, Hospital General Universitario Reina Sofía de MurciaÁngela Cano Yuste, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760665
- Sponsor's protocol ID
- KAPEDIS
- Acronym
- KAPEDIS
- Status last verified
- Jul 2024
- First submitted
- 15 Feb 2021
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Perez-Nadales E, Cano A, Recio M, Artacho MJ, Guzman-Puche J, Doblas A, Vidal E, Natera C, Martinez-Martinez L, Torre-Cisneros J, Caston JJ. Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing Klebsiella pneumoniae (KAPEDIS). BMJ Open. 2022 Apr 6;12(4):e058124. doi: 10.1136/bmjopen-2021-058124.
PubMed 35387830
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Superiority, Double Blind Controlled With Placebo, Clinical Trial, to Demonstrate the Effectiveness of Fecal Microbiota Transplantation for Selective Intestinal Decolonization of Patients Colonized by Klebsiella Pneumoniae Carbapenemase (KPC)-Producing
- ClinicalTrials.gov ID
- NCT04760665
- Acronym / sponsor ID
- KAPEDIS / KAPEDIS
- Keywords
- fecal microbiota transplantation, Klebsiella pneumoniae, carbapenemase, intestinal colonization, decolonization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of elegible population
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Mikrobiomik Healthcare Company S.L.
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 24 Nov 2023 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infections caused by carbapenemase-producing Enterobacteriaceae are frequent and often associated with high rates of mortality. Colonized patients are at increased risk of infection for these microorganisms. Moreover, they can act as a reservoir facilitating the transmission to other patients. To date, decolonization strategies with antibiotics have not obtained convincing results. For that reason our main objective is to investigate the efficacy of fecal microbiota transplantation (FMT) for selective intestinal decolonization of patients colonized by KPC-producing Klebsiella pneumoniae (Kp-KPC) at 30 days after FMT. Our hypothesis is that FMT is effective and safe for selective intestinal decolonization in patients colonized by Kp-KPC. The design of the study is a randomized, superiority, double blind controlled with placebo clinical trial.
The main variable is the percentage of patients with intestinal decolonization at 30 days after FMT in intention to treat population (all randomized patients). Decolonization will be considered as the abscence of isolation of Kp-KPC in culture from rectal swab together with the abscence of detection of carbapenemase by mean of polymerase chain reaction.
Secondary objectives are:
- To evaluate the safety of FMT.
- To determine if FMT is associated with decrease in the amount of bacteria at 7 days after FMT and 30 days after FMT.
- To evaluate if FMT is associated with persistent intestinal decolonization at 3 months after intervention.
- To study if FMT is associated with decrease in the incidence of Kp-KPC infections at 3 months after intervention.
- To evaluate if FMT is associated with decrease in mortality due to Kp-KPC infections at 3 months after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplantation | Experimental | Biological: Fecal microbiota transplantation |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age> = 18 years.
- Signature of the informed consent by the patient or legally designated person
- Absence of active infection by carbapenemase-type KPC-producing Klebsiella pneumoniae at the time of assessment as well as in the month prior to inclusion in the study
Key exclusion criteria (14 listed)
- Terminal situation, or estimated life expectancy of less than 3 months
- Pregnant or lactating women
- Intolerance or inability to take oral medication at the time of assessment
- History of aspiration or dysphagia
- Patients with a history of colectomy, colostomy or ileostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantationPatients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients. | Biological | Fecal microbiota transplantation |
| PlaceboPatients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT. | Other | Placebo |
Primary outcome
Decolonization
Time frame: 30 days after treatment.
Percentage of patients with intestinal decolonization after receiving oral capsules of FMT or placebo in intention to treat population.
5 secondary outcomes
Percentage of patients with adverse effects
Time frame: 90 days after treatment.
Bacterial load
Time frame: 7 days and 30 days after treatment.
Persistent intestinal decolonization
Time frame: 90 days after treatment.
Infections caused by Kp-KPC
Time frame: 90 days after treatment.
Mortality
Time frame: 90 days after treatment.
Results and safety
The study was stopped early (reason given: lack of elegible population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 35387830Perez-Nadales E, Cano A, Recio M, Artacho MJ, Guzman-Puche J, Doblas A, Vidal E, Natera C, Martinez-Martinez L, Torre-Cisneros J, Caston JJ. Randomised, double-blind, placebo-controlled, phase 2, superiority trial to demonstrate the effectiveness of faecal microbiota transplantation for selective intestinal decolonisation of patients colonised by carbapenemase-producing Klebsiella pneumoniae (KAPEDIS). BMJ Open. 2022 Apr 6;12(4):e058124. doi: 10.1136/bmjopen-2021-058124.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan José Castón Osorio, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
Ángela Cano Yuste, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal microbiota transplantation in people with Carbapenemase-producing Enterobacteriaceae Infection, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of elegible population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decolonization (time frame: 30 days after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.