CandidiasisPhase 2NCT00330395
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
A Phase 2 study testing caspofungin acetate in people with Candidiasis, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection). Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Candidiasis
- What is being tested?
- caspofungin acetate
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates and infants <3 months of age
- Patient has a body weight greater than or equal to 500 grams
- Patient has documented or highly suspected Candida infection
Who cannot join
- Patient is greater than 3 months of age
- Patient has a body weight of less than 500 grams
- Patient does not meet certain laboratory testing criteria
- Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
- Patient has documented HIV infection of any stage
- Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class
About this study
Official title: A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).
- Conditions
- Candidiasis
- Being tested
- caspofungin acetate
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caspofungin acetateDrug
Also called MK0991
Duration of Treatment 28 Days
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of drug exposure
Secondary outcomes (1)
Safety and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CandidiasisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330395
- Sponsor's protocol ID
- 0991-058
- Other IDs
- MK0991-058, 2006_025
- Status last verified
- Feb 2017
- First submitted
- 24 May 2006
- Last updated
- 23 Feb 2017
- Results posted
- No
Publications
Saez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.
PubMed 19075070
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.
- ClinicalTrials.gov ID
- NCT00330395
- Acronym / sponsor ID
- 0991-058
- Conditions
- Candidiasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 26 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants <3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates and infants <3 months of age
- Patient has a body weight greater than or equal to 500 grams
- Patient has documented or highly suspected Candida infection
Key exclusion criteria (6 listed)
- Patient is greater than 3 months of age
- Patient has a body weight of less than 500 grams
- Patient does not meet certain laboratory testing criteria
- Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
- Patient has documented HIV infection of any stage
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 |
|---|---|---|
| caspofungin acetateAlso: MK0991Duration of Treatment 28 Days | Drug | – |
Primary outcome
Pharmacokinetic parameters of drug exposure
1 secondary outcome
Safety and tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 19075070Saez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing caspofungin acetate in people with Candidiasis, 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 3 inclusion and 6 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 23 Feb 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetic parameters of drug exposure. 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 NCT00330395, 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 23 Feb 2017.