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CandidemiaPhase 2STRIVENCT02734862

CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension

A Phase 2 study testing CD101, Caspofungin and Fluconazole in people with Candidemia and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 63 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Candidemia, Mycoses, Fungal Infection
What is being tested?
CD101, Caspofungin and Fluconazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
207 participants
Where
63 sitesin 10 countries
Study dates
26 Jul 2016to Jul 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

  • mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
  • willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
  • female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
  • male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
  • willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on their behalf.
  • presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis

Who cannot join

  • Any of the following forms of IC:
  • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
  • Osteomyelitis
  • Endocarditis or myocarditis
  • Meningitis, endophthalmitis, or any central nervous system infection
  • neutropenia
Show all 16Show fewer
  • alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal
  • severe hepatic impairment in subjects with a history of chronic cirrhosis
  • greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia
  • pregnant females
  • lactating females who are nursing
  • known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients
  • previous participation in this or any previous CD101 study
  • recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening
  • Principal Investigator considers the subject should not participate
  • presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia

Trial locations and contacts

63 sites in 10 countries.

63 sites in 10 countries

United States16 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Augusta University

    Augusta, Georgia, 30912

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Mercury Street Medical

    Butte, Montana, 59701

  • University of California - Davis

    Davis, California, 95817

  • Harper University Hospital

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Virginia Tech, Carillion School of Medicine

    Roanoke, Virginia, 24016

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Health - St. Vincent Medical Center - ID Clinical Research

    Toledo, Ohio, 43608

  • Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19611

Other trials in United States

Spain12 sites

  • University Hospital Cruces, Unit of Infectious Diseases

    Barakaldo, 48903

  • University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases

    Barcelona, Catalonia, 08035

  • Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases

    Barcelona, Catalonia, 08036

  • Hospital del Mar, Department of Infectious Diseases

    Barcelona, 08003

  • General University Hospital Gregorio Maranon

    Madrid, 28007

  • University Hospital Ramon y Cajal

    Madrid, 28034

  • University Hospital Clinical San Carlos

    Madrid, 28040

  • University Hospital La Paz

    Madrid, 28046

  • University Hospital Virgen Macarena

    Seville, 41009

  • University Hospital Nuestra Senora de Valme,

    Seville, 41014

  • University Hospital Virgen del Rocio (HUVR)

    Seville

  • University Hospital La Fe

    Valencia, 46026

Other trials in Spain

Belgium8 sites

  • Jules Bordet Institute

    Brussels, 1000

  • CHU Brugman

    Brussels, 1020

  • Erasme Hospital

    Brussels, 1070

  • UCL Saint-LUC

    Brussels, 1200

  • UZ Gent Algemene Inwendige Zietken

    Ghent, 9000

  • University Hospital Brussels

    Jette, 1090

  • University Hospital Leuven

    Leuven, 3000

  • CHU Sart-Tillman

    Liège, 4000

Other trials in Belgium

Greece6 sites

  • University General Hospital "Attikon", 2nd Department of Critical Care

    Athens, Chaidari, 12 462

  • General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit

    Athens, 10676

  • Laiko General Hospital of Athens

    Athens, 115 27

  • Henry Dunant Hospital Center

    Athens, 11526

  • General Hospital of Athens "Evangelismos", Department of Critical Care

    Athens

  • University Hospital of Larissa, Department of Critical Care Unit

    Thessaloniki, 41110

Other trials in Greece

Italy6 sites

  • Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases

    Bologna, 40138

  • University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I

    Modena, 41124

  • University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases

    Pisa, 56124

  • University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2

    Rome, 00168

  • Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID

    Trieste, 34125

  • University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases

    Udine, 33100

Other trials in Italy

Canada4 sites

  • Juravinski Hospital and Cancer Centre/Hamilton Health Sciences

    Hamilton, Ontario, L8V 1C3

  • CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre-Research Institute

    Montreal, Quebec, H4A 3J1

  • Toronto General Hospital-University Health Network

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Romania4 sites

  • Institute of Infectious Diseases

    Bucharest, Sector 2, 021105

  • Craiova County Emergency Clinical Hospital, ATI Clinic

    Craiova, Dolj, 200642

  • Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases

    Iași, 700116

  • Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania)

    Timișoara, Timiș County, 300723

Other trials in Romania

Russia3 sites

  • Kuban State Medical University

    Krasnodar, 350063

  • Territorial Clinical Hospital

    Krasnoyarsk, 660022

  • Mariinskaya City Hospital

    Saint Petersburg, 191104

Other trials in Russia

Bulgaria2 sites

  • University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care

    Sofia, 1606

Other trials in Bulgaria

Hungary2 sites

  • Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department

    Budapest, 1134

  • Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit

    Szeged, 6725

Other trials in Hungary

About this study

Official title: A Phase 2, Multicenter, Randomized, Double-blind Study of the Safety, Tolerability, and Efficacy of Intravenous CD101 vs Intravenous Caspofungin Followed by Oral Fluconazole Step-down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis

The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Read the detailed description

This Bridging Extension is to determine if intravenous CD101 is safe [Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia] and effective [Day 14 (± 1 day)] in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).

Being tested
CD101, Caspofungin, Fluconazole, intravenous placebo, oral placebo
Keywords
mycoses
Medical subject headings
Candidemia, Mycoses, Fungemia, Candidiasis, Invasive

What participants receive

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

  • CD101Drug

    Also called CD101 for Injection

    Intravenous antifungal therapy

  • CaspofunginDrug

    Also called Cancidas

    Intravenous antifungal therapy

  • FluconazoleDrug

    Also called generic fluconazole

    oral antifungal therapy

  • intravenous placeboDrug

    Also called placebo infusion

    normal saline

  • oral placeboDrug

    Also called encapsulated cellulose

    microcrystalline cellulose

Study groups in NCT02734862
Study groupRoleWhat they receive
Group 1ExperimentalSubjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.
Receives: Drug: CD101; Drug: intravenous placebo; Drug: oral placebo
Group 3Active comparatorSubjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg [4 capsules] on the first day followed by 400 mg [2 capsules]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind.
Receives: Drug: Caspofungin; Drug: Fluconazole; Drug: intravenous placebo
Group 2ExperimentalSubjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down.
Receives: Drug: CD101; Drug: intravenous placebo; Drug: oral placebo

What is being measured

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

  1. Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]

    Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.

    Measured: From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

  2. Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]

    Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline

    Measured: Day 14 (± 1 day)

Secondary outcomes (6)

  1. Mycological Eradication and Resolution of Systemic Signs

    Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.

    Measured: Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

  2. Mycological Eradication

    Evaluate mycological success (eradication) in the mITT population.

    Measured: Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia)

  3. Clinical Cure

    Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements:

    • Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline
    • No new systemic signs or symptoms attributable to candidemia/IC
    • No additional systemic antifungal therapy administered for candidemia/IC
    • The subject is alive

    Measured: Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).

  4. Evaluate PK (Cmax)

    Evaluate maximum plasma concentration (Cmax) (Part A only)

    Measured: Day 1, 10 minutes before end of infusion (EOI)

  5. Evaluate PK (Cmin)

    Evaluate minimum plasma concentration (Cmin) (Part A only)

    Measured: Day 8, predose

  6. Evaluate PK (Cmin)

    Evaluate minimum plasma concentration (Cmin) (Part A only)

    Measured: Day 15, predose

Timeline

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

  1. First posted12 Apr 2016 (estimated)
  2. Study start26 Jul 2016
  3. Primary completionJun 2019
  4. Study completionJul 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02734862
Sponsor's protocol ID
CD101.IV.2.03
Other IDs
2015-005599-51, 2015
Acronym
STRIVE
Status last verified
Dec 2020
First submitted
16 Mar 2016
Last updated
8 Dec 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ostrosky-Zeichner L, Aram JA, Redell M, Thompson GR 3rd, Cornely OA, McKinnell JA, Spec A, Pappas PG. Exploring Early Antifungal Activity of Rezafungin as a Stepping-Stone for Shorter Treatment Duration for Candidemia: Pooled Analysis of 2 Randomized Trials. Open Forum Infect Dis. 2026 Mar 21;13(4):ofag143. doi: 10.1093/ofid/ofag143. eCollection 2026 Apr.

    PubMed 41940006

  • Honore PM, Bassetti M, Cornely OA, Dupont H, Fortun J, Kollef MH, Pappas P, Pullman J, Vazquez J, Bielicka I, Dickerson S, Manamley N, Sandison T, Thompson GR. Length of hospital and intensive care unit stay in patients with invasive candidiasis and/or candidemia treated with rezafungin: a pooled analysis of two randomised controlled trials. Crit Care. 2024 Nov 11;28(1):361. doi: 10.1186/s13054-024-05152-2.

    PubMed 39529079

  • Honore PM, Girardis M, Kollef M, Cornely OA, Thompson GR 3rd, Bassetti M, Soriano A, Huang H, Vazquez J, Kullberg BJ, Pappas PG, Manamley N, Sandison T, Pullman J, Nseir S. Rezafungin versus caspofungin for patients with candidaemia or invasive candidiasis in the intensive care unit: pooled analyses of the ReSTORE and STRIVE randomised trials. Crit Care. 2024 Oct 28;28(1):348. doi: 10.1186/s13054-024-05117-5.

    PubMed 39468640

  • Smith HL, Bensman TJ, Mishra S, Li X, Dixon CA, Sheikh J, McMaster OG, Joshi A, Rubin DB, Goodwin A, Miller TJ, Danielsen ZY, Syed I, Shukla SJ, Iarikov D, Kim PW, Farley JJ. Regulatory Considerations in the Approval of Rezafungin (Rezzayo) for the Treatment of Candidemia and Invasive Candidiasis in Adults. J Infect Dis. 2024 Aug 16;230(2):505-513. doi: 10.1093/infdis/jiae146.

    PubMed 38502709

  • Thompson GR 3rd, Soriano A, Honore PM, Bassetti M, Cornely OA, Kollef M, Kullberg BJ, Pullman J, Hites M, Fortun J, Horcajada JP, Kotanidou A, Das AF, Sandison T, Aram JA, Vazquez JA, Pappas PG. Efficacy and safety of rezafungin and caspofungin in candidaemia and invasive candidiasis: pooled data from two prospective randomised controlled trials. Lancet Infect Dis. 2024 Mar;24(3):319-328. doi: 10.1016/S1473-3099(23)00551-0. Epub 2023 Nov 23.

    PubMed 38008099

  • Thompson GR, Soriano A, Skoutelis A, Vazquez JA, Honore PM, Horcajada JP, Spapen H, Bassetti M, Ostrosky-Zeichner L, Das AF, Viani RM, Sandison T, Pappas PG. Rezafungin Versus Caspofungin in a Phase 2, Randomized, Double-blind Study for the Treatment of Candidemia and Invasive Candidiasis: The STRIVE Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3647-e3655. doi: 10.1093/cid/ciaa1380.

    PubMed 32955088

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CD101, Caspofungin and Fluconazole in people with Candidemia and Mycoses, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 63 sites in 10 countries.

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 6 inclusion and 16 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 8 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 63 sites in United States, Spain, Belgium, Greece, Italy and 5 more countries. 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 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 8 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?

Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] (time frame: From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.). 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 NCT02734862, which also lists 6 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 8 Dec 2020.

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