Invasive CandidiasisPhase 4MSG-01NCT00520234
Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)
A Phase 4 study testing Caspofungin and Normal Saline in people with Invasive Candidiasis, run by Mycoses Study Group at 12 sites in United States.
Trial summary
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis
- What is being tested?
- Caspofungin and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 222 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2007to Mar 2010
- Phase
- Phase 4
- 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
- Non-pregnant >18 yrs of age
- Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
- Subjects meeting the clinical prediction rule
Who cannot join
- Subjects with an allergy/intolerance to caspofungin or echinocandin analog
- absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
- acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
- moderate or severe hepatic insufficiency
- subjects who are pregnant or lactating
- unlikely to survive < 24 hours
Show all 10Show fewer
- subjects who have received systemic antifungal therapy within 10 days prior to study entry
- Documented active proven or probable invasive fungal infection upon enrollment
- previously enrolled in this study
- Currently on another investigational agent or have received an investigational agent within 10 days prior to study entry.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35124
Cooper University Hospital
Camden, New Jersey, 08103
Medical Center of South Carolina
Charleston, South Carolina, 29425
The Ohio State University
Columbus, Ohio, 43210
University of Colorado
Denver, Colorado, 80262
Harper University Hospital/ Wayne State
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
University of Southern California
Los Angeles, California, 29425
St. Patrick's Hospital
Missoula, Montana, 59802
Tulane University
New Orleans, Louisiana, 70112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
- Conditions
- Invasive Candidiasis
- Being tested
- Caspofungin, Normal Saline
- Keywords
- Candida, Prophylaxis, High risk adults, Intensive care unit (ICU)
- Medical subject headings
- Candidiasis, Invasive, Torulopsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
50 mg IV daily
Normal SalineDrug
Also called placebo
100 cc IV daily
| Study group | Role | What they receive |
|---|---|---|
| 1 prophylaxis | Active comparator | Caspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy Receives: Drug: Caspofungin |
| 2 placebo | Placebo comparator | Normal Saline 100 cc IV daily Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.
Measured: Within 7 days after end of therapy
Secondary outcomes (10)
Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.
Measured: Within 7 days of end of therapy
All Cause Mortality
Measured: Within 7 days of end of therapy
Initiation of Other Antifungals
Measured: Within 7 days after end of therapy
Time to Development of Proven or Probable Invasive Candidiasis
Measured: Within 7 days after end of therapy
Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.
Measured: Within 7 days after end of therapy
Time to Beta Glucan Negativity in Pre-emptive Phase.
Measured: Within 14 days after end of therapy
Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.
Measured: Within 14 days after end of therapy
Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.
Measured: Hospital discharge
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event
Measured: Up to 14 days after end of therapy
Subjects With 1 or More Serious Drug-related Adverse Event(s)
Measured: Up to 14 days after end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2010
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 (5)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mycoses Study Group
- Sponsor type
- Research network
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Luis Ostrosky-Zeichner, MD, Principal investigator, The University of Texas Health Science Center, HoustonPeter G Pappas, MD, Principal investigator, Mycoses Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520234
- Sponsor's protocol ID
- MSG-01
- Acronym
- MSG-01
- Status last verified
- Apr 2011
- First submitted
- 21 Aug 2007
- Last updated
- 9 May 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302. doi: 10.1128/JCM.40.4.1298-1302.2002.
PubMed 11923348Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.
PubMed 7548503Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
PubMed 1542320Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. doi: 10.1093/jac/dkf045. No abstract available.
PubMed 12039879Ostrosky-Zeichner L, Shoham S, Vazquez J, Reboli A, Betts R, Barron MA, Schuster M, Judson MA, Revankar SG, Caeiro JP, Mangino JE, Mushatt D, Bedimo R, Freifeld A, Nguyen MH, Kauffman CA, Dismukes WE, Westfall AO, Deerman JB, Wood C, Sobel JD, Pappas PG. MSG-01: A randomized, double-blind, placebo-controlled trial of caspofungin prophylaxis followed by preemptive therapy for invasive candidiasis in high-risk adults in the critical care setting. Clin Infect Dis. 2014 May;58(9):1219-26. doi: 10.1093/cid/ciu074. Epub 2014 Feb 18.
PubMed 24550378
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Trial of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in High-risk Adults in the Critical Care Setting
- ClinicalTrials.gov ID
- NCT00520234
- Acronym / sponsor ID
- MSG-01 / MSG-01
- Conditions
- Invasive Candidiasis
- Keywords
- Candida, Prophylaxis, High risk adults, Intensive care unit (ICU)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Mycoses Study GroupResearch network
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Posted 9 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adults admitted to intensive care units are at risk for a variety of complications. Infections due to the fungus called candida are of particular concern. The study will test the possibility that caspofungin, a new therapy for fungal infections, can successfully reduce the rate of candida infections in subjects at risk. It will also test if caspofungin is useful in treating subjects for this disease when diagnosed using a new blood test that is performed twice weekly, permitting earlier diagnosis than current practice standards.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 prophylaxis | Active comparator | Drug: CaspofunginCaspofungin 50 mg Intravenous (IV) daily up to 28 days of therapy |
| 2 placebo | Placebo comparator | Drug: Normal SalineNormal Saline 100 cc IV daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant >18 yrs of age
- Subjects admitted to ICU during the preceding 3 days and expected to stay in the ICU for at least another 48 hours.Subjects can be enrolled on days 3-5 of ICU admission.
- Subjects meeting the clinical prediction rule
Key exclusion criteria (10 listed)
- Subjects with an allergy/intolerance to caspofungin or echinocandin analog
- absolute neutrophil count <500/mm3 at study entry or likely to develop such a count during therapy
- acquired immunodeficiency syndrome, aplastic anemia or chronic granulomatous disease
- moderate or severe hepatic insufficiency
- subjects who are pregnant or lactating
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 |
|---|---|---|
| Caspofungin50 mg IV daily | Drug | 1 prophylaxis |
| Normal SalineAlso: placebo100 cc IV daily | Drug | 2 placebo |
Primary outcome
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.
Time frame: Within 7 days after end of therapy
Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.
10 secondary outcomes
Incidence of Proven Invasive Candidiasis by MSG/ EORTC Criteria.
Time frame: Within 7 days of end of therapy
All Cause Mortality
Time frame: Within 7 days of end of therapy
Initiation of Other Antifungals
Time frame: Within 7 days after end of therapy
Time to Development of Proven or Probable Invasive Candidiasis
Time frame: Within 7 days after end of therapy
Incidence of Proven and Probable Invasive Fungal Infections Other Than Invasive Candidiasis.
Time frame: Within 7 days after end of therapy
Time to Beta Glucan Negativity in Pre-emptive Phase.
Time frame: Within 14 days after end of therapy
Incidence of Complete and Partial Response by Clinical and Microbiological or Serological Evidence for Subjects on the Pre-emptive Therapy Phase.
Time frame: Within 14 days after end of therapy
Hospital Metrics (to be Evaluated Separately for Prophylaxis and Pre-emptive Therapy Phases); Length of Stay in the Hospital, Length of Stay in the ICU, and the Costs Data for the ICU Stay and the Hospitalization, if Available.
Time frame: Hospital discharge
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event
Time frame: Up to 14 days after end of therapy
Subjects With 1 or More Serious Drug-related Adverse Event(s)
Time frame: Up to 14 days after end of therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11923348Diekema DJ, Messer SA, Brueggemann AB, Coffman SL, Doern GV, Herwaldt LA, Pfaller MA. Epidemiology of candidemia: 3-year results from the emerging infections and the epidemiology of Iowa organisms study. J Clin Microbiol. 2002 Apr;40(4):1298-302. doi: 10.1128/JCM.40.4.1298-1302.2002.
- Background: PubMed 7548503Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis. 1995 Jun;20(6):1526-30. doi: 10.1093/clinids/20.6.1526.
- Background: PubMed 1542320Goodman JL, Winston DJ, Greenfield RA, Chandrasekar PH, Fox B, Kaizer H, Shadduck RK, Shea TC, Stiff P, Friedman DJ, et al. A controlled trial of fluconazole to prevent fungal infections in patients undergoing bone marrow transplantation. N Engl J Med. 1992 Mar 26;326(13):845-51. doi: 10.1056/NEJM199203263261301.
- Background: PubMed 12039879Denning DW. Echinocandins: a new class of antifungal. J Antimicrob Chemother. 2002 Jun;49(6):889-91. doi: 10.1093/jac/dkf045. No abstract available.
- Derived from this study: PubMed 24550378Ostrosky-Zeichner L, Shoham S, Vazquez J, Reboli A, Betts R, Barron MA, Schuster M, Judson MA, Revankar SG, Caeiro JP, Mangino JE, Mushatt D, Bedimo R, Freifeld A, Nguyen MH, Kauffman CA, Dismukes WE, Westfall AO, Deerman JB, Wood C, Sobel JD, Pappas PG. MSG-01: A randomized, double-blind, placebo-controlled trial of caspofungin prophylaxis followed by preemptive therapy for invasive candidiasis in high-risk adults in the critical care setting. Clin Infect Dis. 2014 May;58(9):1219-26. doi: 10.1093/cid/ciu074. Epub 2014 Feb 18.
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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.
Luis Ostrosky-Zeichner, MD principal investigator
The University of Texas Health Science Center, Houston
Peter G Pappas, MD principal investigator
Mycoses Study Group
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caspofungin and Normal Saline in people with Invasive Candidiasis, run by Mycoses Study Group at 12 sites 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 3 inclusion and 10 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 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 May 2011). 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?
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria. (time frame: Within 7 days after end of therapy). 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 NCT00520234, which also lists 5 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 9 May 2011.