Clostridium Difficile InfectionPhase 3NCT01597505

Study of CB-183,315 in Participants With Clostridium Difficile Associated Diarrhea (MK-4261-005)

A Phase 3 study testing Surotomycin and Vancomycin in people with Clostridium Difficile Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

606 participants with Clostridium Difficile Associated Diarrhea (CDAD) participated in this study and received either oral vancomycin or CB-183,315 (surotomycin) in a blinded fashion. Treatment lasted for 10 days and participants were followed up for at least 40 days and a maximum of 100 days. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Clostridium Difficile Infection
What is being tested?: Surotomycin and Vancomycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 606 participants
Where: No sites listed yet
Study dates: 16 May 2012to 20 Mar 2015
Phase: Phase 3
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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

To be included in this study, participants must:

Sign a consent form;
Be >= 18 and < 90 years of age;
Have diarrhea, at least 3 times during one day, or 200 mL or liquid stool if using a rectal device;
Test positive for Clostridium difficile;
If female, must not be pregnant or nursing and take appropriate measures to not get pregnant during the study.

Participants will not be allowed into the study if they:

Have toxic megacolon and/or known small bowel ileus;
Have received treatment with intravenous immune globulin (IVIG) within the past 30 days;
Have received treatment with a fecal transplant within 7 days, and/or if the doctor anticipates to give the participant a fecal transplant during the study;
Have received a certain amount of antibacterial therapy specific for current CDAD, unless it is not working;
Have received an investigational vaccine against C. difficile;
Have received an investigational product containing monoclonal antibodies against toxin A or B within 180 days;
Had more than 2 episodes of CDAD within 90 days;
Had major gastrointestinal (GI) surgery (i.e. significant bowel resection) within 3 months (this does not include appendectomy or cholecystectomy);
Have history of prior inflammatory bowel disease: ulcerative colitis, Crohn's disease, or microscopic colitis;
Are unable to discontinue loperamide, diphenoxylate/atropine, or cholestyramine during the duration of the study;
Are unable to discontinue opiate treatment unless on a stable dose;
Has known positive stool cultures for other enteropathogens including but not limited to Salmonella, Shigella, and Campylobacter;
Had stool studies positive for pathogenic ova and/or parasites;
Have an intolerance or hypersensitivity to daptomycin and/or vancomycin;
Have life-threatening illness at the time of enrollment;
Have poor concurrent medical risks that in the opinion of the Investigator the participant should not enroll;
Have received an investigational drug or participated in any experimental procedure within 1 month;
Have human immunodeficiency virus (HIV), a cluster of differentiation 4 (CD4) < 200 cells/mm3 within 6 months of start of study therapy;
Anticipate that certain antibacterial therapy for a non-CDAD infection will be required for > 7 days;
Are unable to discontinue Saccharomyces or similar probiotic;
Are on a concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy;
Are unable to comply with the protocol requirements;
Have any condition that, in the opinion of the Investigator, might interfere;
Are not expected to live for less than 8 weeks.

About this study

Official title: A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea

Conditions: Clostridium Difficile Infection
Being tested: Surotomycin, Vancomycin, Placebo
Keywords: CDAD, Clostridium difficile Associated Diarrhea, CDI, Clostridium difficile Infection, Diarrhea
Medical subject headings: Clostridium Infections, Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurotomycinDrug
Also called CB-183,315
250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days
VancomycinDrug
125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
PlaceboDrug
Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days

Study groups in NCT01597505
Study group	Role	What they receive
Surotomycin	Experimental	250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days Receives: Drug: Surotomycin; Drug: Placebo
Vancomycin	Active comparator	125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days Receives: Drug: Vancomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
Measured: Up to 13 days
Percentage of Participants With at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
Measured: Up to Day 50
Percentage of Participants With at Least One Serious Adverse Event (SAE)
A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.
Measured: Up to Day 50
Percentage of Participants Who Discontinued Treatment Due to an AE
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
Measured: Up to Day 13

Secondary outcomes (10)

Number of Participants With Clinical Response Over Time
Clinical response over time as measured by those without treatment failure, recurrence, death, or lost to follow-up, measured as the number of participants without failure events (survivors) through the end of therapy (reported for Day 14) and from end of therapy to Day 40 (reported for Day 41).
Measured: Up to Day 41
Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study
Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 50
Adjusted Percentage of Participants With Sustained Clinical Response at Day 24
Sustained clinical response at Day 24 was defined as participants who had a clinical outcome of cure at Day 24, who did not experience a recurrence of CDAD, did not die, were not lost to follow-up. Only the first failure event was counted per participant. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Day 24
Adjusted Percentage of Participants With Recurrence of CDAD at End of Study
Participants with recurrences were defined as those who were cured at the end of therapy and had a recurrence or were lost to follow-up, died or had a Day 40 -50 contact prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 50
Time to Resolution of Diarrhea
Time to resolution of diarrhea with =< 2 unformed bowel movements (UBM) per 24-hour period was calculated as the date/time of last UBM minus the date/time of the first dose of study drug.
Measured: Up to Day 13
Time to Reappearance of Diarrhea From End of Treatment to the End of Study
Time to reappearance of diarrhea with >= 3 UBM per 24-hour period was calculated as the last date/time of study drug dose to the date/time of first reappearance of 3 or more UBMs among participants who were cured at end of treatment.
Measured: Up to Day 50
Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 13
Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment
Clinical response corresponded to a clinical outcome of cure at the end of treatment, and was achieved by participants who did not fail treatment, did not die, or were not lost to follow-up at the end of treatment. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 13
Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
Sustained clinical response at the end of study was achieved by participants with infections deemed to be caused by the C. difficile BI/NAP1/027 strain at baseline, who had a clinical outcome of cure at the end of treatment (Day 13) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 50
Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study
Sustained clinical response at the end of study was achieved by participants who had a clinical outcome of cure at the end of treatment (Days 40-50) and did not experience a recurrence of CDAD, did not die, were not lost to follow-up, and did not have end of study visit prior to Day 40. Only the first failure event per participant was counted. The estimated adjusted percentage was a weighted average across all strata, constructed using MRc stratum weights.
Measured: Up to Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 201220 Mar 2015

First posted14 May 2012 (estimated)
Study start16 May 2012
Primary completion20 Mar 2015
Study completion20 Mar 2015

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Clostridium Difficile 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01597505
Sponsor's protocol ID: 4261-005
Other IDs: LCD-CDAD-10-07, MK-4261-005, 2012-000252-34
Status last verified: Jul 2019
First submitted: 10 May 2012
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Boix V, Fedorak RN, Mullane KM, Pesant Y, Stoutenburgh U, Jin M, Adedoyin A, Chesnel L, Guris D, Larson KB, Murata Y. Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With Clostridium difficile Infection. Open Forum Infect Dis. 2017 Jan 19;4(1):ofw275. doi: 10.1093/ofid/ofw275. eCollection 2017 Winter.
PubMed 28480267
Cheknis A, Devaris D, Chesnel L, Dale SE, Nary J, Sambol SP, Citron DM, Goering RV, Johnson S. Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities. J Antimicrob Chemother. 2020 Nov 1;75(11):3120-3125. doi: 10.1093/jac/dkaa297.
PubMed 32747931

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Clostridium Difficile Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blinded, Active-Controlled Study of CB-183,315 in Patients With Clostridium Difficile Associated Diarrhea
ClinicalTrials.gov ID: NCT01597505
Acronym / sponsor ID: 4261-005
Conditions: Clostridium Difficile Infection
Keywords: CDAD, Clostridium difficile Associated Diarrhea, CDI, Clostridium difficile Infection, Diarrhea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 16 May 2012 (actual)
Primary completion: 20 Mar 2015 (actual)
Study completion: 20 Mar 2015 (actual)
First posted: 14 May 2012 (estimated)
Results: Posted 28 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Surotomycin	Experimental	Drug: Surotomycin, Drug: Placebo250 mg Surotomycin over- encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg; and Placebo over encapsulated tablet administered orally, twice daily for 10 days
Vancomycin	Active comparator	Drug: Vancomycin125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
SurotomycinAlso: CB-183,315250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days	Drug	Surotomycin
Vancomycin125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days	Drug	Vancomycin
PlaceboPlacebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days	Drug	Surotomycin

Primary outcome

Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)
Time frame: Up to 13 days
A clinical outcome of cure at EOT was determined by resolution of diarrhea, defined as ≤ 2 loose stools per 24-hour period for at least 2 consecutive days and the lack of need for additional antibiotics to treat the current CDAD episode after completion of the study treatment period. Participants requiring a collection device were considered to have resolution of diarrhea when the volume of stool (over a 24-hour period) was decreased by 75% as compared to baseline or the participant was no longer passing liquid stool. The estimated adjusted percentage was a weighted average across all strata, constructed using Mehrotra-Railkar continuity-corrected minimum risk (MRc) stratum weights.
Percentage of Participants With at Least One Adverse Event (AE)
Time frame: Up to Day 50
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).
Percentage of Participants With at Least One Serious Adverse Event (SAE)
Time frame: Up to Day 50
A SAE is any adverse experience occurring at any dose that results in any of the following outcomes: death; a life-threatening experience, referring to a situation in which the participant was at risk of death at the time of the event, requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; or is considered to be an important medical event.
Percentage of Participants Who Discontinued Treatment Due to an AE
Time frame: Up to Day 13
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. AEs may be new events or may be pre-existing conditions that have become aggravated or have worsened in severity or frequency; or may be clinically significant changes from baseline in physical examination, laboratory tests, or other diagnostic investigation (e.g. laboratory results, x-ray findings).

10 secondary outcomes

Number of Participants With Clinical Response Over Time
Time frame: Up to Day 41
Adjusted Percentage of Participants With Sustained Clinical Response at the End of Study
Time frame: Up to Day 50
Adjusted Percentage of Participants With Sustained Clinical Response at Day 24
Time frame: Day 24
Adjusted Percentage of Participants With Recurrence of CDAD at End of Study
Time frame: Up to Day 50
Time to Resolution of Diarrhea
Time frame: Up to Day 13
Time to Reappearance of Diarrhea From End of Treatment to the End of Study
Time frame: Up to Day 50
Adjusted Percentage of Participants With a Clinical Response at the End of Treatment for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
Time frame: Up to Day 13
Adjusted Percentage of Participants Per Protocol 1 Population With a Clinical Response at the End of Treatment
Time frame: Up to Day 13
Adjusted Percentage of Participants With a Sustained Clinical Response at the End of Study for Infections Deemed to be Caused by the C. Difficile BI/NAP1/027 Strain at Baseline
Time frame: Up to Day 50
Adjusted Percentage of Participants From the Per Protocol 2 Population With a Sustained Clinical Response at the End of Study
Time frame: Up to Day 50

Results and safety

Results posted to the registry on 28 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surotomycin	308	264
Vancomycin	298	265

Primary outcome: Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT)

Time frame: Up to 13 days. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Surotomycin n = 290	Vancomycin n = 280
Value	79.0 (73.9 to 83.2)	83.6 (78.8 to 87.4)

Surotomycin vs Vancomycin: Difference in percentage of participants: -4.6 (95% CI -11.0 to 1.9)

Population analysed: The population analyzed is the Microbiological Modified Intent-To-Treat (mMITT) population consisting of all randomized participants who had a confirmed diagnosis of CDAD regardless of whether they received any amount of study drug, based on the treatment to which they were randomized.

Primary outcome: Percentage of Participants With at Least One Adverse Event (AE)

Time frame: Up to Day 50. Number. Unit: Percentage of participants

Measure	Surotomycin n = 305	Vancomycin n = 286
Value	48.5	55.2

Population analysed: All randomized participants who received any amount of study drug

Primary outcome: Percentage of Participants With at Least One Serious Adverse Event (SAE)

Time frame: Up to Day 50. Number. Unit: Percentage of participants

Measure	Surotomycin n = 305	Vancomycin n = 286
Value	14.4	12.9

Population analysed: All randomized participants who received any amount of study drug

Primary outcome: Percentage of Participants Who Discontinued Treatment Due to an AE

Time frame: Up to Day 13. Number. Unit: Percentage of participants

Measure	Surotomycin n = 305	Vancomycin n = 286
Value	5.6	2.8

Population analysed: All randomized participants who received any amount of study drug

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs were collected up to Day 13; only SAEs and drug related AEs were collected thereafter 30 days after end of treatment (up to Day 50). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surotomycin	44 of 305 (14.4%)	38 of 305 (12.5%)	18 of 305
Vancomycin	37 of 286 (12.9%)	38 of 286 (13.3%)	9 of 286

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28480267Boix V, Fedorak RN, Mullane KM, Pesant Y, Stoutenburgh U, Jin M, Adedoyin A, Chesnel L, Guris D, Larson KB, Murata Y. Primary Outcomes From a Phase 3, Randomized, Double-Blind, Active-Controlled Trial of Surotomycin in Subjects With Clostridium difficile Infection. Open Forum Infect Dis. 2017 Jan 19;4(1):ofw275. doi: 10.1093/ofid/ofw275. eCollection 2017 Winter.
Derived from this study: PubMed 32747931Cheknis A, Devaris D, Chesnel L, Dale SE, Nary J, Sambol SP, Citron DM, Goering RV, Johnson S. Characterization of Clostridioides difficile isolates recovered from two Phase 3 surotomycin treatment trials by restriction endonuclease analysis, PCR ribotyping and antimicrobial susceptibilities. J Antimicrob Chemother. 2020 Nov 1;75(11):3120-3125. doi: 10.1093/jac/dkaa297.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Surotomycin and Vancomycin in people with Clostridium Difficile Infection, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 23 Jul 2019. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 28 Feb 2018). 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?

Adjusted Percentage of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT) (time frame: Up to 13 days). The study lists 4 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 NCT01597505, 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 23 Jul 2019.