Trial · NCT00761267
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
NCT00761267, Phase 3, Completed, Pfizer; results first posted 2018-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis. Trials, record NCT00761267. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00761267
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
- NCT number
- NCT00761267
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 70 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Candidemia
- Interventions
- Anidulafungin, Fluconazole
- First posted
- 2008-09-29
- Last updated
- 2019-04-04
- Other registries' IDs
- eudract:2008-004150-32
- Results first posted
- 2018-09-14
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 6 weeks after EOT (up to 91 days) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after end of treatment (EOT) (up to 91 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. EOT visit defined as last day of study treatment (IV or oral). |
| Primary | Number of Participants With Laboratory Abnormalities | Baseline up to 6 weeks after EOT (up to 91 days) | Criteria for laboratory abnormalities: Hematology parameters: red blood cell count: \<0.8\*lower limit of normal (LLN); reticulocytes count (absolute or percent): \<0.5\*LLN or greater than (\>) 1.5\*upper limit of normal (ULN); Platelets: \<0.5\*LLN or \>1.75\*ULN; white blood cell count: \<0.6\*LLN or \>1.5\*ULN; neutrophils (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; basophils (absolute or percent): \>1.2\*ULN; lymphocytes (absolute or percent): \<0.8\*LLN or \>1.2\*ULN; monocytes (absolute or percent): \>1.2\*ULN. Serum Chemistry parameters: sodium: \<0.95\*LLN or \>1.05\*ULN, potassium, chloride, bicarbonate, calcium: \<0.9\*LLN or \>1.1\*ULN; magnesium: \>1.1\*ULN or \<0.9\*LLN; BUN (blood urea nitrogen): \>1.3\* ULN, creatinine: \>1.3\*ULN; aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase : \>3.0\*ULN ; total bilirubin: \>1.5\*ULN; albumin: \<0.8\*LLN or \>1.2\*ULN and glucose: \<0.6\*LLN or \>1.5\*ULN.EOT visit defined as last day of study treatment (IV or oral). |
| Secondary | Number of Participants With Global Response | End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) | Global response categorized: success, failure, indeterminate.Success:clinical response(CR) of cure(resolution of sign, symptoms attributed to Candida infection\[CI\]; no additional systemic/oral antifungal) or improvement (significant but incomplete resolution of signs symptoms of CI; no additional systemic antifungal) and microbiological eradication/presumed eradication(Baseline pathogen not isolated from original site culture/culture data not available for participant with successful outcome).Failure:CR of failure(no significant improvement in signs symptoms/ death due to CI)and/or microbiological failure(persistence/new infection at follow-up/relapse of infection at follow-up). Indeterminate:CR of indeterminate(evaluation not made or failure assessment)and/or microbiological response of indeterminate(Culture data not available for participant with clinical outcome of indeterminate) and neither response was failure.EOT visit:last day of study treatment (IV or oral). |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion | Non-compartmental PK analysis was performed on individual plasma anidulafungin concentration-time data collected by serial sampling from participants in the PK sub-study. AUC24 was calculated based on the trapezoidal rule. |
| Secondary | Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion | Cmax was obtained directly from the observed concentration data on Day 2. |
| Secondary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 microgram per milliliter (mcg/mL). PK time points were assessed on Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. |
| Secondary | Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose | Excipient PS 80 is a solubilizing agent contained in the IV formulation of anidulafungin. The lower limit of quantitation (LLOQ) for all the observations of PS 80 was 5.0 mcg/ml. PK time points were assessed on at Day 1, Day 3, Day 5, Day 7 and Day 9. Summarized data for all the time points was reported. |
| Secondary | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | AUC24 values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. |
| Secondary | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | Cmin values were calculated using the individual parameter estimates obtained from the final population PK model. PK time points were assessed on Days 1-3, Day 5, Day 7, and Day 9. Data for all time points were included in the model. |
| Secondary | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days) | The probability of having at least one hepatic adverse event was compared with AUC0-24,ss quantile. Individual parameter estimates from the final PK model were used for estimation of Anidulafungin exposures. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 6 weeks after EOT (up to 91 days) | The safety population included all randomized participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities | Baseline up to 6 weeks after EOT (up to 91 days) | The safety population included all randomized participants who received at least 1 dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Global Response | End of intravenous treatment (EOIVT) (maximum of 35 days), EOT (maximum of 49 days), during 2 week follow-up after EOT (up to 63 days) and during 6 week follow-up after EOT (up to 91 days) | The mITT population was defined as all participants who had received at least 1 dose of study drug and who had microbiological confirmation of Candida infection. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12 and 24 hours after the start of infusion | PK subgroup population included the first 6 participants aged between 1 month to \<2 years. | nanogram*hour per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Anidulafungin for Pharmacokinetic (PK) Subgroup | Day 2: Just prior to the start of infusion, 2 minutes before the end of infusion, 6, 12, and 24 hours after the start of infusion | PK subgroup population included the first 6 participants aged between 1 month to \<2 years. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration Versus Time Curve From Time Zero to 24 Hours (AUC24) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours and 24 hours delayed post-dose | The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Polysorbate 80 (PS 80) Following Infusion of Anidulafungin for PK Subgroup | Day 1: 0 to 2 hours post dose; Day 3 and Day 9:pre-dose; Day 5: 0 to 3 hours post dose; Day 7: 6 to 12 hours delayed post-dose | The PK subgroup population for PS80 included the last eight participants aged between 1 month to \<2 years. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Estimated Area Under the Plasma Curve Over a 24-Hour Dosing Interval at Steady State (AUC0-24ss) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | PK population included all those participants who had 1 or more PK samples available. | microgram*hour per milliliter(mcg*hr/ml) | MEAN |
| SECONDARY | Estimated Minimum Plasma Concentration (Cmin) of Anidulafungin | Sparse Sampling:Day 1:0-2 hr after end of infusion (EOI); Day3&9:pre-dose;Day 5:0-3hr post EOI; Day 7:6-12hr after EOI.For 1st 6 infants:< 2 years:Day 1:2 minutes before EOI; Day 2:pre infusion, 2 minutes before EOI, 6, 12,24 hours after start of infusion | PK population included all those participants who had 1 or more PK samples available. | microgram per milliliter (mcg/ml) | MEAN |
| SECONDARY | Number of Participants With Greater Than or Equal to 1 Hepatic Adverse Event Categorized on the Basis of Exposure to Anidulafungin (AUC0-24,ss) | Baseline to End of intravenous treatment (EOIVT) (maximum of 35 days) | Analysis performed on all participants who received at least one dose of the study treatment (Anidulafungin) and had estimable exposure parameters available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group118
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | AEs | 17 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin: Participants Aged 2 to <5 Years | AEs | 19 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin: Participants Aged 5 to <18 Years | AEs | 30 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | SAEs | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin: Participants Aged 2 to <5 Years | SAEs | 10 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Anidulafungin: Participants Aged 5 to <18 Years | SAEs | 13 | Participants | |
| Number of Participants With Laboratory Abnormalities | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 19 | Participants | ||
| Number of Participants With Laboratory Abnormalities | Anidulafungin: Participants Aged 2 to <5 Years | 18 | Participants | ||
| Number of Participants With Laboratory Abnormalities | Anidulafungin: Participants Aged 5 to <18 Years | 30 | Participants | ||
| Number of Participants With Global Response | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | EOIVT / Success | 11 | Participants |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 20 | |
| Overall Study | STARTED | Anidulafungin: Participants Aged 2 to <5 Years | 20 | |
| Overall Study | STARTED | Anidulafungin: Participants Aged 5 to <18 Years | 30 | |
| Overall Study | Treated | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 19 | |
| Overall Study | Treated | Anidulafungin: Participants Aged 2 to <5 Years | 19 | |
| Overall Study | Treated | Anidulafungin: Participants Aged 5 to <18 Years | 30 | |
| Overall Study | COMPLETED | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 18 | |
| Overall Study | COMPLETED | Anidulafungin: Participants Aged 2 to <5 Years | 16 | |
| Overall Study | COMPLETED | Anidulafungin: Participants Aged 5 to <18 Years | 24 | |
| Overall Study | NOT COMPLETED | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events762
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agranulocytosis | Blood and lymphatic system disorders | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 0 | 19 | |
| other | Agranulocytosis | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 2 to <5 Years | 1 | 19 | |
| other | Agranulocytosis | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 5 to <18 Years | 0 | 30 | |
| other | Anaemia | Blood and lymphatic system disorders | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 5 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 2 to <5 Years | 3 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 5 to <18 Years | 1 | 30 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 0 | 19 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 2 to <5 Years | 0 | 19 | |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Anidulafungin: Participants Aged 5 to <18 Years | 1 | 30 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 0 | 19 |
1 to 10 of 762Source ClinicalTrials.gov
See all 762 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 1 | 19 |
| Total, all-cause mortality | Anidulafungin: Participants Aged 2 to <5 Years | 2 | 19 |
| Total, all-cause mortality | Anidulafungin: Participants Aged 5 to <18 Years | 5 | 30 |
| Total, other adverse events | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 17 | 19 |
| Total, other adverse events | Anidulafungin: Participants Aged 2 to <5 Years | 17 | 19 |
| Total, other adverse events | Anidulafungin: Participants Aged 5 to <18 Years | 30 | 30 |
| Total, serious adverse events | Anidulafungin:Participants Aged 1 Month to Less Than(<)2 Years | 7 | 19 |
| Total, serious adverse events | Anidulafungin: Participants Aged 2 to <5 Years | 10 | 19 |
| Total, serious adverse events | Anidulafungin: Participants Aged 5 to <18 Years | 13 | 30 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT00761267/results?page=2