Anti-Biotic ResistancePhase 1/2NCT00722410
Probiotics for Eradication of Carbapenem Resistant Klebsiella Pneumonia
A Phase 1/2 study testing VSL#3 and Polyethylene glycol in people with Anti-Biotic Resistance and Klebsiella Pneumoniae, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti-Biotic Resistance, Klebsiella Pneumoniae
- What is being tested?
- VSL#3 and Polyethylene glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Sep 2010
- Phase
- Phase 1/2
- 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
- Subjects who are > 18 years of age.
- Signing of informed consent by subject or legal custodian.
- Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
- Negative cultures for CRKP from extra-intestinal sites excluding urine.
Who cannot join
- Subjects who have participated in another clinical trial within the last three months.
- Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
- Subjects who are pregnant or breast feeding.
- Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
- Subjects with chronic diarrhea (>4 weeks).
- Subjects with inflammatory bowel disease.
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- Subjects whose stool is positive for Clostridium difficile toxin.
- Subjects receiving immunosuppressive treatment (i.e. corticosteroids; azathioprine or 6-MP; cyclosporine; tacrolimus; OKT3, methotrexate; anti TNF agents; chemotherapy).
- Subjects who underwent solid organ or hematopoietic stem cell transplantation.
- Subjects with primary or secondary immunodeficiency disorders, including HIV.
- Subjects with chronic advanced cardiac, respiratory, renal or liver disease.
- Subjects with advanced malignant disease.
- Subjects with severe acute organ failure.
- Subjects in whom CRKP is isolated from sites other than stool or urine (i.e. blood, sputum or wound cultures).
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lamberg, PhD, : 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.
Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.
Read the detailed description
CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry.
- Conditions
- Anti-Biotic Resistance, Klebsiella Pneumoniae
- Being tested
- VSL#3, Polyethylene glycol
- Keywords
- Carbapenem, resistant, Klebsiella pneumoniae, Carpapenemases, Probiotics, VSL3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
A probiotic preparation.
Polyethylene glycolDrug
Also called New Meroken., Precolonoscopy solution.
Oral ingestion of 3 liters of polyethylene glycol solution.
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Not described |
| B | Experimental | VSL#3 for 4 weeks Receives: Dietary Supplement: VSL#3 |
| C | Experimental | Mechanical bowel cleansing followed by VSL#3 for 4 weeks. Receives: Dietary Supplement: VSL#3; Drug: Polyethylene glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
Measured: 4 weeks.
Secondary outcomes (1)
A negative stool culture and/or PCR assay for CRKP at twelve weeks after initiation of probiotics (i.e - 8 weeks after cessation of probiotic treatment).
Measured: 12 weeks beginning of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anti-Biotic ResistanceStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Investigators
- Maya Margalit, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722410
- Sponsor's protocol ID
- CRKP-HMO-CTIL
- Status last verified
- Jul 2008
- First submitted
- 23 Jul 2008
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Leavitt A, Navon-Venezia S, Chmelnitsky I, Schwaber MJ, Carmeli Y. Emergence of KPC-2 and KPC-3 in carbapenem-resistant Klebsiella pneumoniae strains in an Israeli hospital. Antimicrob Agents Chemother. 2007 Aug;51(8):3026-9. doi: 10.1128/AAC.00299-07. Epub 2007 Jun 11.
PubMed 17562800Manley KJ, Fraenkel MB, Mayall BC, Power DA. Probiotic treatment of vancomycin-resistant enterococci: a randomised controlled trial. Med J Aust. 2007 May 7;186(9):454-7. doi: 10.5694/j.1326-5377.2007.tb00995.x.
PubMed 17484706
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Eradication of Carbapenem Resistant Klebsiella Pneumonia From the Gastrointestinal Tract by Probiotics.
- ClinicalTrials.gov ID
- NCT00722410
- Acronym / sponsor ID
- CRKP-HMO-CTIL
- Conditions
- Anti-Biotic Resistance, Klebsiella Pneumoniae
- Keywords
- Carbapenem, resistant, Klebsiella pneumoniae, Carpapenemases, Probiotics, VSL3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 25 Jul 2008 (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.
Infection by Klebsiella pneumonia producing class A carbapenemases is a major clinical and public health problem in Israel and worldwide. The aim of this study is to determine the safety and efficacy of alteration of the gut microflora by probiotics, alone or in combination with mechanical bowel cleansing, as a strategy to eradicate colonization of the gastrointestinal tract by CRKP. We hypothesize that administration of probiotics will decrease the rate of GI colonization by CRKP.
Detailed description
CRKP colonization will be determined by culture and PCR of rectal swabs. The study will include 3 arms - no intervention, probiotics and mechanical bowel cleansing + probiotics. Followup examination of rectal swab samples for the presence of CRKP will be performed at 4 weeks and 12 weeks from study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | – |
| B | Experimental | Dietary Supplement: VSL#3VSL#3 for 4 weeks |
| C | Experimental | Dietary Supplement: VSL#3, Drug: Polyethylene glycolMechanical bowel cleansing followed by VSL#3 for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are > 18 years of age.
- Signing of informed consent by subject or legal custodian.
- Colonization of the gastrointestinal tract by CRKP as determined by stool culture or PCR of stool for the blakpc gene.
- Negative cultures for CRKP from extra-intestinal sites excluding urine.
Key exclusion criteria (14 listed)
- Subjects who have participated in another clinical trial within the last three months.
- Women with childbearing potential unless using adequate contraception (IUD, oral or depot contraceptive or barrier plus spermicide).
- Subjects who are pregnant or breast feeding.
- Subjects who will be unavailable for the duration of the trial, are likely to be non-compliant with the protocol, or who are felt to be unsuitable by the investigator for any other reason.
- Subjects with chronic diarrhea (>4 weeks).
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 |
|---|---|---|
| VSL#3A probiotic preparation. | Dietary supplement | B, C |
| Polyethylene glycolAlso: New Meroken., Precolonoscopy solution.Oral ingestion of 3 liters of polyethylene glycol solution. | Drug | C |
Primary outcome
A negative stool culture for Carbapenem resistant Klebsiella pneumonia.
Time frame: 4 weeks.
1 secondary outcome
A negative stool culture and/or PCR assay for CRKP at twelve weeks after initiation of probiotics (i.e - 8 weeks after cessation of probiotic treatment).
Time frame: 12 weeks beginning of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2008.
- Background: PubMed 17562800Leavitt A, Navon-Venezia S, Chmelnitsky I, Schwaber MJ, Carmeli Y. Emergence of KPC-2 and KPC-3 in carbapenem-resistant Klebsiella pneumoniae strains in an Israeli hospital. Antimicrob Agents Chemother. 2007 Aug;51(8):3026-9. doi: 10.1128/AAC.00299-07. Epub 2007 Jun 11.
- Background: PubMed 17484706Manley KJ, Fraenkel MB, Mayall BC, Power DA. Probiotic treatment of vancomycin-resistant enterococci: a randomised controlled trial. Med J Aust. 2007 May 7;186(9):454-7. doi: 10.5694/j.1326-5377.2007.tb00995.x.
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.
Maya Margalit, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VSL#3 and Polyethylene glycol in people with Anti-Biotic Resistance and Klebsiella Pneumoniae, run by Hadassah Medical Organization at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Jul 2008. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maya Margalit, MD (972-50-7874561, mayam@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A negative stool culture for Carbapenem resistant Klebsiella pneumonia. (time frame: 4 weeks.). 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 NCT00722410, which also lists 2 linked publications.
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 25 Jul 2008.