Infection Due to Resistant OrganismPhase 1PREMIXNCT02922816
FMT for MDRO Colonization After Infection in Renal Transplant Recipients
A Phase 1 study testing Fecal Microbiota Transplant (FMT), Bowel preparation and Stool or perirectal swab sampling in people with Infection Due to Resistant Organism, run by Emory University at 1 site in United States.
Trial summary
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Due to Resistant Organism
- What is being tested?
- Fecal Microbiota Transplant (FMT), Bowel preparation and Stool or perirectal swab sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2016to 3 Dec 2021
- Phase
- Phase 1
- 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
- Ability to understand and willingness to sign a written informed consent document.
- Ability and willingness to comply with study protocol requirements and receive an enema.
- History of MDRO infection with at least one of the following target MDROs: CRE, VRE, ESBL, or MDR Pseudomonas.
- Prior receipt of a renal transplant.
- If applicable, willingness to discontinue probiotics or other microbiota restoration therapies during screening at least seven days prior to study Day 1.
- The effects of FMT on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
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- Negative blood or urine human chorionic gonadotropin (hCG) testing on the day of FMT for WOCBP with documentation of negative test result.
- Negative baseline Human Immunodeficiency Virus (HIV) test.
- Known serology CMV status confirmed by Medical History (if positive). If no mention of positivity in medical records, serology is tested within 30 days of enrollment for:
- Cytomegalovirus (CMV) by polymerase chain reaction (PCR)
- Cytomegalovirus (CMV), serology Immunoglobulin G (IgG)
Who cannot join
- Female participants who are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product).
- Prior gastrointestinal surgery or intervention:
- Ileostomy (in the last 3 months)
- Colostomy (in the last 3 months)
- Gastric or colon resection (in the last 3 months)
- Bariatric surgery (any prior history)
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- Total colectomy (any prior history)
- Any of the following gastrointestinal conditions:
- Irritable Bowel Syndrome (IBS) with diarrhea in the last 12 months
- Crohn's disease
- Ulcerative Colitis
- Celiac disease
- Untreated in-situ colorectal cancer
- Microscopic colitis
- Toxic megacolon or ileus
- Tube feeding (current or planned)
- Known positive stool studies or cultures in the last 30 days for: Ova or parasites, Salmonella, Shigella, Campylobacter
- Other enteropathogens - defined as any positive result other than C. difficile on the Biofire FilmArray gastrointestinal panel, (Campylobacter, Plesiomonas, Salmonella, Vibrio, Yersinia, Enteroaggregative Escherichia coli (EAEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic Escherichia coli (ETEC), Shigella, Cryptosporidium, Cyclospora, Entamoeba, Giardia, Adenovirus, Astrovirus, Norovirus, Rotavirus, Sapovirus).
- Known uncontrolled intercurrent illness(es) such as, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Acute coronary syndrome
- Cardiac arrhythmia
- Any other intercurrent acute illness that in the opinion of the investigator will preclude subject from entering the study
- On systemic antibiotics for any reason other than recent MDRO infection. If a potential participant is taking antibiotics for treatment (not prophylaxis) of MDRO infection, then the participant must complete the planned antibiotic course by study Day -2.
- Compromised immune system other than transplant immunosuppression:
- HIV-positive as identified by one of the following: Positive HIV test, prior diagnosis of HIV, or active or history of administration of antiretroviral therapy (ART) other than for pre-exposure prophylaxis or post-exposure prophylaxis.
- Known Absolute Neutrophil (ANC) <1000 neutrophils per cubic millimeter (mm^3) in the last 3 months
- Active malignancy requiring intensive induction chemotherapy, radiotherapy, or biologic treatment either concurrently or in the last 2 months
- Acute leukemia
- History of hematopoietic cell transplantation, either allogeneic or autologous in the last 3 years
- History of solid organ transplant rejection in the last 6 months
- Significant food allergy to foods that are part of the stool donor participant's diet.
- Life expectancy is 24 weeks or less.
- Any condition that, in the opinion of the investigator, might interfere with study objectives or limit compliance with study requirements, including but not limited to:
- Known active intravenous drug or alcohol abuse
- Psychiatric illness
- Social situation
- Participated in an investigational study that also meets one of the following criteria:
- Received an interventional agent (drug, device, or procedure) in the last 28 days
- Enrollment on this study or any other interventional study for MDROs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization After Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics.
This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.
Read the detailed description
Potential participants who meet key eligibility criteria [adults who have undergone renal transplantation and have a history of infection with the Target Multidrug Resistant Organisms (MDRO)] will be approached for consideration of study participation. For this study, Target MDRO colonization is defined as a positive bacterial culture of either carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE), Extended Spectrum Beta-Lactamases (ESBL), and/or multidrug resistant (MDR) Pseudomonas from stool or perirectal swab sampling.
The 20 trial participants will be randomized in a 1:1 ratio to one of two arms: the control arm [not receiving Allogeneic Human Stool in Glycerol (10%; AHSG) via Fecal Microbiota Transplant (FMT)] and the experimental arm (receiving AHSG via FMT). Participants in the control arm participants can crossover to receive the treatment after completing a study cycle without FMT. Each cycle lasts 6 weeks and participants will complete a maximum of 2 treatment cycles; participants randomized to the experimental arm will complete a maximum of two cycles and those randomized to the control arm will complete up to three cycles. Upon completion of the final cycle, all trial participants will be followed for just over 6 months.
In addition to the trial participants, there will also be one stool donor participant. The consented, screened, and eligible stool donor will be identified from an established group of stool donors and will undergo screening procedures that are specific to this study. This individual will donate human stool for the preparation of the AHSG (known as the investigational new drug (IND) product for this study). Upon processing of AHSG, the stool donor will enter the Follow-Up Period and remain available for communication to the study team (if necessary) until the Study Completion Date. However, no scheduled study assessments are required of the stool donor.
- Conditions
- Infection Due to Resistant Organism
- Being tested
- Fecal Microbiota Transplant (FMT), Bowel preparation, Stool or perirectal swab sampling, Fasting
- Keywords
- Carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-resistant Enterococcus (VRE), Multidrug Resistant Organism (MDRO), Fecal Microbiota Transplant (FMT), Renal Transplant, Colonization, Infection, Antibiotic Resistance, Resistome, Multidrug Resistant (MDR) Pseudomonas
- Medical subject headings
- Infections, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT)Biological
The Fecal Microbiota Transplant (FMT) using Allogeneic human stool in glycerol (10%) (AHSG) intervention will be administered via rectal retention enema and performed in either an inpatient or outpatient clinic.
Bowel preparationProcedure or surgery
Trial participants will undergo the bowel preparation by taking magnesium citrate the day before the cycle begins (Day -1).
Stool or perirectal swab samplingProcedure or surgery
Stool or perirectal swabs will be collected at screening (for eligibility determination) and Days 1, 2, 15, and 36 of each cycle.
FastingOther
In Cycle 1 and Cycle 2, participants cannot consume food, alcohol, or other liquids on Day 1 prior to the intervention. Trial participants will not be fasting on Day 1 of Cycle 0.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | The control arm will participate in the bowel preparation and stool or perirectal swab sampling but will not receive Fecal Microbiota Transplant (FMT) nor will they be fasting during their first study cycle (Cycle 0). Participants testing positive for a multi-drug resistant organism at the of Cycle 0 will be eligible to receive microbiota restoration transplant (MRT) for up to two cycles, as necessary (Cycles 1 and 2). Receives: Procedure: Bowel preparation; Procedure: Stool or perirectal swab sampling |
| Fecal Microbiota Transplant (FMT) | Experimental | The experimental arm will participate in the bowel preparation, stool or perirectal swab sampling, and will receive Fecal Microbiota Transplant (FMT) using Allogeneic Human Stool in Glycerol 10% (AHSG) on Day 1 of each cycle (Cycles 1 and 2). Receives: Biological: Fecal Microbiota Transplant (FMT); Procedure: Bowel preparation; Procedure: Stool or perirectal swab sampling; Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
The safety and feasibility of using FMT in adult participants with Target MDRO colonization after infection will be measured by comparing the number of adverse events (assessed by CTCAE v4.0) after Day 1 of each cycle as compared to baseline.
Measured: Up to 30 weeks
Change in Target MDRO Growth
The primary outcome is target MDRO growth on perirectal swab or stool culture on Day 36 of each cycle compared Screening and Day 1 culture results. Participants will be classified as having a complete response, partial response, refractory response or progression based on their Day 36 culture results. Partial response, refractory response, and progression may be collapsed in a non-response category for analytic purposes.
Measured: Day 1, Up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start1 Dec 2016
- Primary completion3 Dec 2021
- Study completion3 Dec 2021
Why it stopped: This study was paused and was not resumed due to the COVID-19 pandemic.
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 Infection Due to Resistant OrganismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid
- Responsible party
- Principal investigator, Colleen S. Kraft, Emory University
- Investigators
- Colleen S Kraft, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922816
- Sponsor's protocol ID
- IRB00090101
- Acronym
- PREMIX
- Status last verified
- Nov 2023
- First submitted
- 27 Sep 2016
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified sequencing data may be made available to outside collaborators upon request and approval by study team.
Publications
Woodworth MH, Conrad RE, Haldopoulos M, Pouch SM, Babiker A, Mehta AK, Sitchenko KL, Wang CH, Strudwick A, Ingersoll JM, Philippe C, Lohsen S, Kocaman K, Lindner BG, Hatt JK, Jones RM, Miller C, Neish AS, Friedman-Moraco R, Karadkhele G, Liu KH, Jones DP, Mehta CC, Ziegler TR, Weiss DS, Larsen CP, Konstantinidis KT, Kraft CS. Fecal microbiota transplantation promotes reduction of antimicrobial resistance by strain replacement. Sci Transl Med. 2023 Nov;15(720):eabo2750. doi: 10.1126/scitranslmed.abo2750. Epub 2023 Nov 1.
PubMed 37910603Woodworth MH, Kwon JH, Kraft CS. An Ounce of Prevention Is Equivalent to How Much Decolonization Exactly? Clin Infect Dis. 2021 Jun 1;72(11):e924. doi: 10.1093/cid/ciaa1524. No abstract available.
PubMed 33029623
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using Fecal Microbiota Transplant in Renal Transplant Recipients to Eliminate Multidrug-Resistant Organism Colonization After Infection and Examine Gastrointestinal Carriage in a Randomized Placebo-Controlled Design
- ClinicalTrials.gov ID
- NCT02922816
- Acronym / sponsor ID
- PREMIX / IRB00090101
- Conditions
- Infection Due to Resistant Organism
- Keywords
- Carbapenem-resistant Enterobacteriaceae (CRE), Vancomycin-resistant Enterococcus (VRE), Multidrug Resistant Organism (MDRO), Fecal Microbiota Transplant (FMT), Renal Transplant, Colonization, Infection, Antibiotic Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was paused and was not resumed due to the COVID-19 pandemic.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Cepheid
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 3 Dec 2021 (actual)
- First posted
- 4 Oct 2016 (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.
Transplant patients are at increased risk of colonization and infection with Multidrug Resistant Organisms (MDROs) due to medications that modify their immune systems, increased healthcare and antibiotic exposure, and surgical manipulation of mucosa. In this study, kidney transplant patients who have infections with resistant bacteria will be given a Fecal Microbiota Transplant (FMT), also known as a fecal transplant, after they receive antibiotic treatment. This study will see if FMT will eliminate the resistant bacteria so that the kidney transplant patients do not have to use last resort antibiotics.
This Phase 1 pilot study is to obtain preliminary safety data for FMT in renal transplant patients to support the rationale for a subsequent clinical trial, not to establish efficacy or toxicity. This trial is designed to test the safety of FMT, identify clinical outcomes, assess feasibility, and refine the target population in participants with MDRO colonization and intestinal dysbiosis. Data from this study should provide directions for the design of future clinical trials.
Detailed description
Potential participants who meet key eligibility criteria [adults who have undergone renal transplantation and have a history of infection with the Target Multidrug Resistant Organisms (MDRO)] will be approached for consideration of study participation. For this study, Target MDRO colonization is defined as a positive bacterial culture of either carbapenem-resistant Enterobacteriaceae (CRE), vancomycin-resistant Enterococcus (VRE), Extended Spectrum Beta-Lactamases (ESBL), and/or multidrug resistant (MDR) Pseudomonas from stool or perirectal swab sampling.
The 20 trial participants will be randomized in a 1:1 ratio to one of two arms: the control arm [not receiving Allogeneic Human Stool in Glycerol (10%; AHSG) via Fecal Microbiota Transplant (FMT)] and the experimental arm (receiving AHSG via FMT). Participants in the control arm participants can crossover to receive the treatment after completing a study cycle without FMT. Each cycle lasts 6 weeks and participants will complete a maximum of 2 treatment cycles; participants randomized to the experimental arm will complete a maximum of two cycles and those randomized to the control arm will complete up to three cycles. Upon completion of the final cycle, all trial participants will be followed for just over 6 months.
In addition to the trial participants, there will also be one stool donor participant. The consented, screened, and eligible stool donor will be identified from an established group of stool donors and will undergo screening procedures that are specific to this study. This individual will donate human stool for the preparation of the AHSG (known as the investigational new drug (IND) product for this study). Upon processing of AHSG, the stool donor will enter the Follow-Up Period and remain available for communication to the study team (if necessary) until the Study Completion Date. However, no scheduled study assessments are required of the stool donor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Procedure: Bowel preparation, Procedure: Stool or perirectal swab samplingThe control arm will participate in the bowel preparation and stool or perirectal swab sampling but will not receive Fecal Microbiota Transplant (FMT) nor will they be fasting during their first study cycle (Cycle 0). Participants testing positive for a multi-drug resistant organism at the of Cycle 0 will be eligible to receive microbiota restoration transplant (MRT) for up to two cycles, as necessary (Cycles 1 and 2). |
| Fecal Microbiota Transplant (FMT) | Experimental | Biological: Fecal Microbiota Transplant (FMT), Procedure: Bowel preparation, Procedure: Stool or perirectal swab sampling, Other: FastingThe experimental arm will participate in the bowel preparation, stool or perirectal swab sampling, and will receive Fecal Microbiota Transplant (FMT) using Allogeneic Human Stool in Glycerol 10% (AHSG) on Day 1 of each cycle (Cycles 1 and 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Ability and willingness to comply with study protocol requirements and receive an enema.
- History of MDRO infection with at least one of the following target MDROs: CRE, VRE, ESBL, or MDR Pseudomonas.
- Prior receipt of a renal transplant.
- If applicable, willingness to discontinue probiotics or other microbiota restoration therapies during screening at least seven days prior to study Day 1.
Key exclusion criteria (41 listed)
- Female participants who are pregnant, breastfeeding, lactating, or planning a pregnancy during study duration (through 4 weeks after the last dose of investigational product).
- Prior gastrointestinal surgery or intervention:
- Any of the following gastrointestinal conditions:
- Known positive stool studies or cultures in the last 30 days for: Ova or parasites, Salmonella, Shigella, Campylobacter
- Other enteropathogens - defined as any positive result other than C. difficile on the Biofire FilmArray gastrointestinal panel, (Campylobacter, Plesiomonas, Salmonella, Vibrio, Yersinia, Enteroaggregative Escherichia coli (EAEC), Enteropathogenic Escherichia coli (EPEC), Enterotoxigenic Escherichia coli (ETEC), Shigella, Cryptosporidium, Cyclospora, Entamoeba, Giardia, Adenovirus, Astrovirus, Norovirus, Rotavirus, Sapovirus).
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 Transplant (FMT)The Fecal Microbiota Transplant (FMT) using Allogeneic human stool in glycerol (10%) (AHSG) intervention will be administered via rectal retention enema and performed in either an inpatient or outpatient clinic. | Biological | Fecal Microbiota Transplant (FMT) |
| Bowel preparationTrial participants will undergo the bowel preparation by taking magnesium citrate the day before the cycle begins (Day -1). | Procedure or surgery | Control arm, Fecal Microbiota Transplant (FMT) |
| Stool or perirectal swab samplingStool or perirectal swabs will be collected at screening (for eligibility determination) and Days 1, 2, 15, and 36 of each cycle. | Procedure or surgery | Control arm, Fecal Microbiota Transplant (FMT) |
| FastingIn Cycle 1 and Cycle 2, participants cannot consume food, alcohol, or other liquids on Day 1 prior to the intervention. Trial participants will not be fasting on Day 1 of Cycle 0. | Other | Fecal Microbiota Transplant (FMT) |
Primary outcome
Number of Adverse Events
Time frame: Up to 30 weeks
The safety and feasibility of using FMT in adult participants with Target MDRO colonization after infection will be measured by comparing the number of adverse events (assessed by CTCAE v4.0) after Day 1 of each cycle as compared to baseline.
Change in Target MDRO Growth
Time frame: Day 1, Up to 30 weeks
The primary outcome is target MDRO growth on perirectal swab or stool culture on Day 36 of each cycle compared Screening and Day 1 culture results. Participants will be classified as having a complete response, partial response, refractory response or progression based on their Day 36 culture results. Partial response, refractory response, and progression may be collapsed in a non-response category for analytic purposes.
Results and safety
The study was stopped early (reason given: This study was paused and was not resumed due to the COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Results publication: PubMed 37910603Woodworth MH, Conrad RE, Haldopoulos M, Pouch SM, Babiker A, Mehta AK, Sitchenko KL, Wang CH, Strudwick A, Ingersoll JM, Philippe C, Lohsen S, Kocaman K, Lindner BG, Hatt JK, Jones RM, Miller C, Neish AS, Friedman-Moraco R, Karadkhele G, Liu KH, Jones DP, Mehta CC, Ziegler TR, Weiss DS, Larsen CP, Konstantinidis KT, Kraft CS. Fecal microbiota transplantation promotes reduction of antimicrobial resistance by strain replacement. Sci Transl Med. 2023 Nov;15(720):eabo2750. doi: 10.1126/scitranslmed.abo2750. Epub 2023 Nov 1.
- Derived from this study: PubMed 33029623Woodworth MH, Kwon JH, Kraft CS. An Ounce of Prevention Is Equivalent to How Much Decolonization Exactly? Clin Infect Dis. 2021 Jun 1;72(11):e924. doi: 10.1093/cid/ciaa1524. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified sequencing data may be made available to outside collaborators upon request and approval by study team.
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.
Colleen S Kraft, MD, MSc principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fecal Microbiota Transplant (FMT), Bowel preparation and Stool or perirectal swab sampling in people with Infection Due to Resistant Organism, run by Emory University 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 11 inclusion and 41 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 15 Nov 2023. 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 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.
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: This study was paused and was not resumed due to the COVID-19 pandemic.). 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?
Number of Adverse Events (time frame: Up to 30 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?
On the ClinicalTrials.gov record for NCT02922816, 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 15 Nov 2023.