Candidiasis, EsophagealPhase 2NCT01165320
A Study of Caspofungin (MK-0991) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections (MK-0991-074)
A Phase 2 study testing Caspofungin in people with Candidiasis, Esophageal and Candidiasis, Invasive, run by Merck Sharp & Dohme LLC.
Trial summary
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections. Read more about this study
- Who is it for?
- Ages 3 months to 17 years
- Conditions the study is for
- Candidiasis, Esophageal, Candidiasis, Invasive, Aspergillosis
- What is being tested?
- Caspofungin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2010to 17 Sep 2013
- 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 3 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.
Who cannot join
- Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
- Patients who will receive other systemic antifungal agents for the first time in screening period
About this study
Official title: A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokinetics of MK-0991 (Caspofungin) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
- Being tested
- Caspofungin
- Medical subject headings
- Candidiasis, Candidiasis, Invasive, Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
Also called MK-0991, CANCIDAS®
| Study group | Role | What they receive |
|---|---|---|
| Participants with Esophageal Candidiasis | Experimental | Candida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively. Receives: Drug: Caspofungin |
| Participants with Invasive Candidiasis | Experimental | Candida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively. Receives: Drug: Caspofungin |
| Participants with Aspergillosis | Experimental | Aspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively. Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With an Overall Favorable Response to Therapy
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
Measured: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Percentage of Participants With One or More Drug-Related Adverse Experiences
An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
Measured: Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study start6 Jul 2010
- Primary completion17 Sep 2013
- Study completion17 Sep 2013
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 (1)Papers the sponsor has linked to this study.
- Other trials for Candidiasis, EsophagealStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165320
- Sponsor's protocol ID
- 0991-074
- Other IDs
- 132240
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2010
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Mori M, Imaizumi M, Ishiwada N, Kaneko T, Goto H, Kato K, Hara J, Kosaka Y, Koike K, Kawamoto H, Maeda N, Yoshinari T, Kishino H, Takahashi K, Kawahara S, Kartsonis NA, Komada Y. Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis. J Infect Chemother. 2015 Jun;21(6):421-6. doi: 10.1016/j.jiac.2015.01.009. Epub 2015 Jan 30.
PubMed 25701307
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Noncomparative, Open-label Study to Estimate the Safety, Efficacy, and Pharmacokinetics of MK-0991 (Caspofungin) in Japanese Children and Adolescents With Documented Candida or Aspergillus Infections
- ClinicalTrials.gov ID
- NCT01165320
- Acronym / sponsor ID
- 0991-074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2010 (actual)
- Primary completion
- 17 Sep 2013 (actual)
- Study completion
- 17 Sep 2013 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Posted 23 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study estimates the safety, efficacy, and pharmacokinetics of caspofungin (MK-0991) in Japanese children and adolescents with documented Candida or Aspergillus infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants with Esophageal Candidiasis | Experimental | Drug: CaspofunginCandida infection is strongly suspected based on clinical symptoms and the participant's clinical course, white moss (plaque) is observed on the esophageal mucosa, and therapy via intravenous infusion is judged to be suitable for the present episode of esophageal candidiasis. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively. |
| Participants with Invasive Candidiasis | Experimental | Drug: CaspofunginCandida infection is strongly suspected based on the presence of refractory fever not responding to an antibiotic agent, or clinical symptoms at the site of disease, or the participant's clinical course. In addition, at least 1 of the following criteria must be met: 1) Candida infection is strongly suspected based on radiographic imaging findings and positive serological test for fungus, 2) yeast is observed by direct microscopy or histopathological test of tissue biopsied from the site of disease, or 3) Candida species are observed by culture test of specimens sampled from the site of disease. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively. |
| Participants with Aspergillosis | Experimental | Drug: CaspofunginAspergillus infection is strongly suspected based on clinical symptoms and the participant's clinical course, and characteristic radiographic imaging findings are observed. In addition, at least 1 of the following criteria must be met: 1) risk factors predisposing to an Aspergillus infection, 2) positive serological test for Aspergillus, 3) acute-branching mold with separated hyphae are observed by direct microscopy or histopathological test, or 4) Aspergillus species are observed by culture test. MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively. |
Who may qualify
- Ages
- 3 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.
Key exclusion criteria (2 listed)
- Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
- Patients who will receive other systemic antifungal agents for the first time in screening period
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 |
|---|---|---|
| CaspofunginAlso: MK-0991, CANCIDAS® | Drug | Participants with Aspergillosis, Participants with Esophageal Candidiasis, Participants with Invasive Candidiasis |
Primary outcome
Percentage of Participants With an Overall Favorable Response to Therapy
Time frame: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days
Invasive candidiasis: favorable overall response required resolved clinical findings and negative culture test for Candida species on follow-up. If Candida species were not observed in the baseline blood culture, favorable overall response required resolved clinical findings and resolved or improved radiographic findings. Aspergillosis: favorable overall response required resolved, improved, or unchanged clinical findings and resolved or improved radiographic findings, or resolved or improved clinical findings and resolved, improved, or stable radiographic findings.
Percentage of Participants With One or More Drug-Related Adverse Experiences
Time frame: Invasive candidiasis: up to 70 days; aspergillosis: up to 98 days
An adverse experience (AE) is defined as any unfavorable or unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an AE. A drug-related AE is one judged to be definitely, probably, or possibly related to the study drug.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25701307Mori M, Imaizumi M, Ishiwada N, Kaneko T, Goto H, Kato K, Hara J, Kosaka Y, Koike K, Kawamoto H, Maeda N, Yoshinari T, Kishino H, Takahashi K, Kawahara S, Kartsonis NA, Komada Y. Pharmacokinetics, efficacy, and safety of caspofungin in Japanese pediatric patients with invasive candidiasis and invasive aspergillosis. J Infect Chemother. 2015 Jun;21(6):421-6. doi: 10.1016/j.jiac.2015.01.009. Epub 2015 Jan 30.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caspofungin in people with Candidiasis, Esophageal and Candidiasis, Invasive, run by Merck Sharp & Dohme LLC.
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 1 inclusion and 2 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 27 Aug 2018. 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 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 23 Apr 2014). 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?
Percentage of Participants With an Overall Favorable Response to Therapy (time frame: Invasive candidiasis: up to 56 days; aspergillosis: up to 84 days). 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 NCT01165320, which also lists 1 linked publication.
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 27 Aug 2018.