A Phase 3 interventional study of Active anidulafungin and Active Caspofungin in Candidiasis and Fungemia, sponsored by Pfizer. Terminated at 18 sites in 9 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-08-01.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.
This study's enrollment of 41 is below the median of 91 across 86 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Drug: Active anidulafungin
Drug: Active Caspofungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
Time frame: End of Treatment (Day 14 to Day 42)
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
Time frame: 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Response Based on Clinical Cure and Microbiological Success
A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.
Time frame: EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With Clinical Response
A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.
Time frame: Day 10
Percentage of Participants With Relapse
Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.
Time frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With New Infection
New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.
Time frame: 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Time to Negative Blood Culture
Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.
Time frame: Baseline up to 6-week follow-up (6 weeks after EOT)
Percentage of Participants With All-cause Mortality
All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.
Time frame: Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT)
Time to Death
Time to death (days) was assessed as date of death minus first treatment date plus 1.
Time frame: Baseline up to 6-week follow-up (6 weeks after EOT)
| Milestone | Anidulafungin | Caspofungin |
|---|---|---|
| Started | 28 | 13 |
| Treated | 26 | 13 |
| Completed | 17 | 9 |
| Not completed | 11 | 4 |
| Withdrew: Death | 7 | 4 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Randomized, but not treated | 2 | 0 |
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42) | 83.3 (62.6 to 95.3) | 61.5 (31.6 to 86.1) |
Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| 2-week follow-up | 76.2 (52.8 to 91.8) | 54.5 (23.4 to 83.3) |
| 6-week follow-up | 66.7 (43.0 to 85.4) | 54.5 (23.4 to 83.3) |
A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| EOT (n=21,8) | 81.0 | 62.5 |
| 2-week follow-up (n=16,6) | 87.5 | 100.0 |
| 6-week follow-up (n=15,6) | 93.3 | 100.0 |
A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| Percentage of Participants With Clinical Response | 70.8 (48.9 to 87.4) | 76.9 (46.2 to 95.0) |
Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| 2-week follow-up | 0 | 0 |
| 6-week follow-up | 0 | 0 |
New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| 2-week follow-up | 0 | 0 |
| 6-week follow-up | 0 | 0 |
Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1.
| days | Anidulafungin | Caspofungin |
|---|---|---|
| Time to Negative Blood Culture | 2.0 (2 to 7) | 3.5 (2 to 10) |
All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up.
| percentage of participants | Anidulafungin | Caspofungin |
|---|---|---|
| Baseline to EOT | 3.8 | 15.4 |
| After EOT to 2-week follow-up | 15.4 | 15.4 |
| After 2-week follow-up to 6-week follow-up | 7.7 | 0.0 |
Time to death (days) was assessed as date of death minus first treatment date plus 1.
| days | Anidulafungin | Caspofungin |
|---|---|---|
| Time to Death | 23.0 (6 to 67) | 11.5 (9 to 51) |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anidulafungin | — | 12/26 (46.2%) | 23/26 (88.5%) |
| Caspofungin | — | 7/13 (53.8%) | 11/13 (84.6%) |
| Event | Anidulafungin | Caspofungin |
|---|---|---|
| Cardiac arrestCardiac disorders | 0/26 | 2/13 |
| BradycardiaCardiac disorders | 0/26 | 1/13 |
| Abdominal painGastrointestinal disorders | 2/26 | 0/13 |
| Abdominal sepsisInfections and infestations | 0/26 | 1/13 |
| PeritonitisInfections and infestations | 0/26 | 1/13 |
| Splenic haematomaInjury, poisoning and procedural complications | 0/26 | 1/13 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/26 | 1/13 |
| Hypoxic-ischaemic encephalopathyNervous system disorders | 0/26 | 1/13 |
| Renal failure acuteRenal and urinary disorders | 0/26 | 1/13 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/26 | 1/13 |
| Event | Anidulafungin | Caspofungin |
|---|---|---|
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/26 | 4/13 |
| AnaemiaBlood and lymphatic system disorders | 1/26 | 3/13 |
| VomitingGastrointestinal disorders | 0/26 | 3/13 |
| Staphylococcus test positiveInvestigations | 1/26 | 3/13 |
| Streptococcus test positiveInvestigations | 1/26 | 3/13 |
| HypotensionVascular disorders | 3/26 | 3/13 |
| CoagulopathyBlood and lymphatic system disorders | 0/26 | 2/13 |
| Atrial fibrillationCardiac disorders | 1/26 | 2/13 |
| DiarrhoeaGastrointestinal disorders | 0/26 | 2/13 |
| NauseaGastrointestinal disorders | 1/26 | 2/13 |
| Age Continuous(years) | Anidulafungin | Caspofungin | Total |
|---|---|---|---|
| Mean | 56.3 ± 16.2 | 63.4 ± 16.3 | 58.6 ± 16.4 |
| Sex: Female, Male(Participants) | Anidulafungin | Caspofungin | Total |
|---|---|---|---|
| Female | 9 | 5 | 14 |
| Male | 17 | 8 | 25 |
The record gives a start of Apr 2009, a primary completion of Jun 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2013, 1 year 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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