Stem Cell Transplant ComplicationsPhase 2NCT03030989
A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients
A Phase 2 study testing Chlorhexidine Gluconate 2% Wipe in people with Stem Cell Transplant Complications, run by University of Chicago at 1 site in United States.
Trial summary
This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant Complications
- What is being tested?
- Chlorhexidine Gluconate 2% Wipe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant
- Age 18 and up
Who cannot join
- Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
- Extensive open wounds
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.
- Conditions
- Stem Cell Transplant Complications
- Being tested
- Chlorhexidine Gluconate 2% Wipe, Placebo Wipe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine Gluconate 2% WipeDrug
Placebo WipeDrug
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Active comparator | Not described Receives: Drug: Chlorhexidine Gluconate 2% Wipe |
| Placebo wipe | Placebo comparator | Not described Receives: Drug: Placebo Wipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Primary Blood Stream Infections
Blood stream infections are defined by the presence of bacteria in the blood
Measured: 14 weeks
Number of Participants With Clinical (Culture-negative) Sepsis
Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion2 Jan 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030989
- Sponsor's protocol ID
- IRB16-1059
- Status last verified
- Nov 2020
- First submitted
- 23 Jan 2017
- Last updated
- 10 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Placebo Controlled Clinical Trial Evaluating Effect of Chlorhexidine Gluconate 2% Cloth vs Placebo Cloth Baths on the Incidence of Central Line-Associated Blood Stream Infections in Outpatient Hematopoietic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT03030989
- Acronym / sponsor ID
- IRB16-1059
- Conditions
- Stem Cell Transplant Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- 2 Jan 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of 2% CHG washcloths in an outpatient setting for adults after hematopoietic stem cell transplant in prevention of central line associated blood stream infections. Half of the participants will use 2% CHG washcloths and other half will use placebo washcloths.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Active comparator | Drug: Chlorhexidine Gluconate 2% Wipe |
| Placebo wipe | Placebo comparator | Drug: Placebo Wipe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted to the University of Chicago Hematopoietic Stem Cell Transplant Unit for transplant
- Age 18 and up
Key exclusion criteria (2 listed)
- Experienced an allergy or rash related to use of chlorhexidine washcloths or other chlorhexidine products
- Extensive open wounds
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 |
|---|---|---|
| Chlorhexidine Gluconate 2% Wipe | Drug | Chlorhexidine Gluconate 2% Wipe |
| Placebo Wipe | Drug | Placebo wipe |
Primary outcome
Number of Participants With Primary Blood Stream Infections
Time frame: 14 weeks
Blood stream infections are defined by the presence of bacteria in the blood
Number of Participants With Clinical (Culture-negative) Sepsis
Time frame: 14 weeks
Clinical (culture-negative) sepsis is defined by the presence of low blood pressure without bacteria in the blood
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Stem Cell Transplant Complications
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Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Active, not recruitingObservational study
Delirium in Children Undergoing Stem Cell Transplantation
Stem Cell Transplant Complications, Delirium
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
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.
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 Chlorhexidine Gluconate 2% Wipe in people with Stem Cell Transplant Complications, run by University of Chicago at 1 site in United States.
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 2 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 10 Dec 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Primary Blood Stream Infections (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2020.