Patients Colonized by Klebsiella Pneumoniae.NCT02604849
Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin
An observational study of Patients Colonized by Klebsiella Pneumoniae., run by Maimónides Biomedical Research Institute of Córdoba.
Trial summary
The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Colonized by Klebsiella Pneumoniae.
- What is being tested?
- Neomycin, Streptomycin and Gentamicins
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Nov 2015
- Phase
- Observational
- 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
Study population: The sample consists of all patients who received therapy desconolizacion against Klebsiella Pneumoniae versus those not receiving such therapy.
Who may be able to join
- Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
- Surgery in two weeks
- Transplant in two weeks
- Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
- Recurrent or severe infections
- Institution admission
- Fragile patients at high risk of readmission.
Who cannot join
- The presence of an active infection for Klebsiella Pneumoniae.
- Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.
About this study
The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.
- Being tested
- Neomycin, Streptomycin, Gentamicins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeomycinDrug
StreptomycinDrug
GentamicinsDrug
| Study group | Role | What they receive |
|---|---|---|
| Received therapy desconolizacion against Klebsiella pneumoniae | Not described Receives: Drug: Neomycin; Drug: Streptomycin; Drug: Gentamicins | |
| Patients who do not receive the therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality for any cause during a six-months period after oral therapy gut decontamination.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJul 2012
- Primary completionJul 2015
- Study completionNov 2015
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 Patients Colonized by Klebsiella Pneumoniae.Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604849
- Sponsor's protocol ID
- FCO-NEE-2015-01
- Status last verified
- Nov 2015
- First submitted
- 10 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Machuca I, Gutierrez-Gutierrez B, Perez Cortes S, Gracia-Ahufinger I, Serrano J, Madrigal MD, Barcala J, Rodriguez-Lopez F, Rodriguez-Bano J, Torre-Cisneros J. Oral decontamination with aminoglycosides is associated with lower risk of mortality and infections in high-risk patients colonized with colistin-resistant, KPC-producing Klebsiella pneumoniae. J Antimicrob Chemother. 2016 Nov;71(11):3242-3249. doi: 10.1093/jac/dkw272. Epub 2016 Jul 26.
PubMed 27494911
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intestinal Decontamination in Patients Colonized by Carbapenem-resistant Klebsiella Pneumoniae and Colistin
- ClinicalTrials.gov ID
- NCT02604849
- Acronym / sponsor ID
- FCO-NEE-2015-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015
- First posted
- 13 Nov 2015 (estimated)
- 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.
The identification of all cases (44 patients) was carried out from the database of microbiology, University Hospital Reina Sofía and the University Hospital of Jerez. For the identification of controls, in case of neutropenic patients, all colonized patients that were included during the study period did not receive any decolonitation treatment; in case of non-neutropenic patients it was studied a paired control by the presence of risk factors that indicated the beginning of decolonitation treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received therapy desconolizacion against Klebsiella pneumoniae | – | Drug: Neomycin, Drug: Streptomycin, Drug: Gentamicins |
| Patients who do not receive the therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample consists of all patients who received therapy desconolizacion against Klebsiella Pneumoniae versus those not receiving such therapy.
Key inclusion criteria (7 listed)
- Patients with intestinal colonization by Klebsiella pneumoniae, defined as the presence of a positive rectal swab culture at least 7 days prior to initiation of therapy; and patients considered at risk of developing an invasive infection by Klebsiella pneumoniae:
- Surgery in two weeks
- Transplant in two weeks
- Require medical intervention or has a clinical situation that may predispose to the development of a serious infection (chemotherapy, immunosuppression or neutropenia)
- Recurrent or severe infections
Key exclusion criteria (2 listed)
- The presence of an active infection for Klebsiella Pneumoniae.
- Concomitant use of systemic antibiotics in the 14 days before the start of decolonization therapy.
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 |
|---|---|---|
| Neomycin | Drug | Received therapy desconolizacion against Klebsiella pneumoniae |
| Streptomycin | Drug | Received therapy desconolizacion against Klebsiella pneumoniae |
| Gentamicins | Drug | Received therapy desconolizacion against Klebsiella pneumoniae |
Primary outcome
Mortality for any cause during a six-months period after oral therapy gut decontamination.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Derived from this study: PubMed 27494911Machuca I, Gutierrez-Gutierrez B, Perez Cortes S, Gracia-Ahufinger I, Serrano J, Madrigal MD, Barcala J, Rodriguez-Lopez F, Rodriguez-Bano J, Torre-Cisneros J. Oral decontamination with aminoglycosides is associated with lower risk of mortality and infections in high-risk patients colonized with colistin-resistant, KPC-producing Klebsiella pneumoniae. J Antimicrob Chemother. 2016 Nov;71(11):3242-3249. doi: 10.1093/jac/dkw272. Epub 2016 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Colonized by Klebsiella Pneumoniae., run by Maimónides Biomedical Research Institute of Córdoba.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality for any cause during a six-months period after oral therapy gut decontamination. (time frame: 6 months). 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 NCT02604849, 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 13 Nov 2015.